265 results on '"Ewer, Katie J."'
Search Results
2. Safety and efficacy of malaria vaccine candidate R21/Matrix-M in African children: a multicentre, double-blind, randomised, phase 3 trial
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Mahamar, Almahamoudou, Sanogo, Koualy, Sidibe, Youssoufa, Diarra, Kalifa, Samassekou, Mamoudou, Attaher, Oumar, Tapily, Amadou, Diallo, Makonon, Dicko, Oumar Mohamed, Kaya, Mahamadou, Maguiraga, Seydina Oumar, Sankare, Yaya, Yalcouye, Hama, Diarra, Soumaila, Niambele, Sidi Mohamed, Thera, Ismaila, Sagara, Issaka, Sylla, Mala, Dolo, Amagana, Misidai, Nsajigwa, Simando, Sylvester, Msami, Hania, Juma, Omary, Gutapaka, Nicolaus, Paul, Rose, Mswata, Sarah, Sasamalo, Ibrahim, Johaness, Kasmir, Sultan, Mwantumu, Alexander, Annastazia, Kimaro, Isaac, Lwanga, Kauye, Mtungwe, Mwajuma, Khamis, Kassim, Rugarabam, Lighton, Kalinga, Wilmina, Mohammed, Mohammed, Kamange, Janeth, Msangi, Jubilate, Mwaijande, Batuli, Mtaka, Ivanny, Mhapa, Matilda, Mlaganile, Tarsis, Mbaga, Thabit, Yerbanga, Rakiswende Serge, Samtouma, Wendkouni, Sienou, Abdoul Aziz, Kabre, Zachari, Ouedraogo, Wendinpui Jedida Muriel, Yarbanga, G Armel Bienvenu, Zongo, Issaka, Savadogo, Hamade, Sanon, Joseph, Compaore, Judicael, Kere, Idrissa, Yoni, Ferdinand Lionel, Sanre, Tewende Martine, Ouattara, Seydou Bienvenu, Provstgaard-Morys, Samuel, Woods, Danielle, Snow, Robert W., Amek, Nyaguara, Ngetsa, Caroline J., Ochola-Oyier, Lynette Isabella, Musyoki, Jennifer, Munene, Marianne, Mumba, Noni, Adetifa, Uche Jane, Muiruri, Charles Mwangi, Mwawaka, Jimmy Shangala, Mwaganyuma, Mwatasa Hussein, Ndichu, Martha Njeri, Weya, Joseph Ochieng, Njogu, Kelvin, Grant, Jane, Webster, Jayne, Lakhkar, Anand, Ido, N. Félix André, Traore, Ousmane, Tahita, Marc Christian, Bonko, Massa dit Achille, Rouamba, Toussaint, Ouedraogo, D. Florence, Soma, Rachidatou, Millogo, Aida, Ouedraogo, Edouard, Sorgho, Faizatou, Konate, Fabé, Valea, Innocent, Datoo, Mehreen S, Dicko, Alassane, Tinto, Halidou, Ouédraogo, Jean-Bosco, Hamaluba, Mainga, Olotu, Ally, Beaumont, Emma, Ramos Lopez, Fernando, Natama, Hamtandi Magloire, Weston, Sophie, Chemba, Mwajuma, Compaore, Yves Daniel, Issiaka, Djibrilla, Salou, Diallo, Some, Athanase M, Omenda, Sharon, Lawrie, Alison, Bejon, Philip, Rao, Harish, Chandramohan, Daniel, Roberts, Rachel, Bharati, Sandesh, Stockdale, Lisa, Gairola, Sunil, Greenwood, Brian M, Ewer, Katie J, Bradley, John, Kulkarni, Prasad S, Shaligram, Umesh, and Hill, Adrian V S
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- 2024
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3. Safety and immunogenicity of a ChAdOx1 vaccine against Rift Valley fever in UK adults: an open-label, non-randomised, first-in-human phase 1 clinical trial
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Jenkin, Daniel, Wright, Daniel, Folegatti, Pedro M, Platt, Abigail, Poulton, Ian, Lawrie, Alison, Tran, Nguyen, Boyd, Amy, Turner, Cheryl, Gitonga, John N, Karanja, Henry K, Mugo, Daisy, Ewer, Katie J, Bowden, Thomas A, Gilbert, Sarah C, Charleston, Bryan, Kaleebu, Pontiano, Hill, Adrian V S, and Warimwe, George M
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- 2023
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4. Efficacy and immunogenicity of R21/Matrix-M vaccine against clinical malaria after 2 years' follow-up in children in Burkina Faso: a phase 1/2b randomised controlled trial
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Datoo, Mehreen S, Natama, Hamtandi Magloire, Somé, Athanase, Bellamy, Duncan, Traoré, Ousmane, Rouamba, Toussaint, Tahita, Marc Christian, Ido, N Félix André, Yameogo, Prisca, Valia, Daniel, Millogo, Aida, Ouedraogo, Florence, Soma, Rachidatou, Sawadogo, Seydou, Sorgho, Faizatou, Derra, Karim, Rouamba, Eli, Ramos-Lopez, Fernando, Cairns, Matthew, Provstgaard-Morys, Samuel, Aboagye, Jeremy, Lawrie, Alison, Roberts, Rachel, Valéa, Innocent, Sorgho, Hermann, Williams, Nicola, Glenn, Gregory, Fries, Louis, Reimer, Jenny, Ewer, Katie J, Shaligram, Umesh, Hill, Adrian V S, and Tinto, Halidou
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- 2022
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5. Safety and immunogenicity of a simian-adenovirus-vectored rabies vaccine: an open-label, non-randomised, dose-escalation, first-in-human, single-centre, phase 1 clinical trial
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Jenkin, Daniel, Ritchie, Adam J, Aboagye, Jeremy, Fedosyuk, Sofiya, Thorley, Luke, Provstgaad-Morys, Samuel, Sanders, Helen, Bellamy, Duncan, Makinson, Rebecca, Xiang, Zhi Quan, Bolam, Emma, Tarrant, Richard, Ramos Lopez, Fernando, Platt, Abigail, Poulton, Ian, Green, Catherine, Ertl, Hildegund C J, Ewer, Katie J, and Douglas, Alexander D
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- 2022
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6. Reactogenicity and immunogenicity after a late second dose or a third dose of ChAdOx1 nCoV-19 in the UK: a substudy of two randomised controlled trials (COV001 and COV002)
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Adlou, Syed, Aley, Robert, Ali, Aabidah, Anslow, Rachel, Baker, Megan, Baker, Phillip, Barrett, Jordan R., Bates, Louise, Beadon, Kirsten, Beckley, Rebecca, Bell, Jonathan, Bellamy, Duncan, Beveridge, Amy, Bissett, Cameron, Blackwell, Luke, Bletchly, Heather, Boyd, Amy, Bridges-Webb, Alice, Brown, Charlie, Byard, Nicholas, Camara, Susana, Cifuentes Gutierrez, Liliana, Collins, Andrea M., Cooper, Rachel, Crocker, Wendy E.M., Darton, Thomas C., Davies, Hannah, Davies, Judith, Demissie, Tesfaye, Di Maso, Claudio, Dinesh, Tanya, Donnellan, Francesca R., Douglas, Alexander D., Drake-Brockman, Rachael, Duncan, Christopher J.A., Elias, Sean C., Emary, Katherine R.W., Ghulam Farooq, Mutjaba, Faust, Saul N., Felle, Sally, Ferreira, Daniela, Ferreira Da Silva, Carla, Finn, Adam, Ford, Karen J., Francis, Emma, Furze, Julie, Fuskova, Michelle, Galiza, Eva, Gibertoni Cruz, Ana, Godfrey, Leila, Goodman, Anna L., Green, Catherine, Green, Christopher A., Greenwood, Nicola, Harrison, Daisy, Hart, Thomas C., Hawkins, Sophia, Heath, Paul T., Hill, Helen, Hillson, Kushalinii, Horsington, Bryn, Hou, Mimi M., Howe, Elizabeth, Howell, Nicola, Joe, Carina, Jones, Elizabeth, Kasanyinga, Mwila, Keen, Jade, Kelly, Sarah, Kerr, David, Khan, Liaquat, Khozoee, Baktash, Kinch, Jasmin, Kinch, Patrick, Koleva, Stanislava, Kwok, Jonathan, Larkworthy, Colin W., Lawrie, Alison M., Lazarus, Rajeka, Lees, Emily A., Li, Grace, Libri, Vincenzo, Lillie, Patrick J., Linder, Aline, Long, Fei, Lopez Ramon, Raquel, Mabbett, Reece, Makinson, Rebecca, Marinou, Spyridoula, Marlow, Emma, Marshall, Julia L., Mazur, Olga, McEwan, Joanne, McGregor, Alastair C., Mokaya, Jolynne, Morey, Ella, Morshead, Gertraud, Morter, Richard, Muller, Jilly, Mweu, Philomena, Noristani, Rabiullah, Owino, Nelly, Polo Peralta Alvarez, Marco, Platt, Abigail, Pollock, Katrina M., Poulton, Ian, Provstgaard-Morys, Samuel, Pulido-Gomez, David, Rajan, Matthew, Ramos Lopez, Fernando, Ritchie, Adam, Roberts, Hannah, Rollier, Christine, Rudiansyah, Indra, Sanders, Katherine, Saunders, Jack E., Seddiqi, Samiullah, Sharpe, Hannah R., Shaw, Robert, Silva-Reyes, Laura, Singh, Nisha, Smith, David J., Smith, Catherine C., Smith, Andrew, Spencer, Alexandra J., Stuart, Arabella S.V., Sutherland, Rebecca, Szigeti, Anna, Tang, Karly, Thomas, Merin, Thomas, Tonia M., Thompson, Amber, Thomson, Emma C., Török, Estée M., Toshner, Mark, Tran, Nguyen, Trivett, Rose, Turnbull, Iain, Turner, Cheryl, Turner, David P.J., Ulaszewska, Marta, Vichos, Iason, Walker, Laura, Watson, Marion E., Whelan, Conor, White, Rachel, Williams, Sarah J., Williams, Christopher J.A., Wright, Daniel, Yao, Andy, Flaxman, Amy, Marchevsky, Natalie G, Jenkin, Daniel, Aboagye, Jeremy, Aley, Parvinder K, Angus, Brian, Belij-Rammerstorfer, Sandra, Bibi, Sagida, Bittaye, Mustapha, Cappuccini, Federica, Cicconi, Paola, Clutterbuck, Elizabeth A, Davies, Sophie, Dejnirattisai, Wanwisa, Dold, Christina, Ewer, Katie J, Folegatti, Pedro M, Fowler, Jamie, Hill, Adrian V S, Kerridge, Simon, Minassian, Angela M, Mongkolsapaya, Juthathip, Mujadidi, Yama F, Plested, Emma, Ramasamy, Maheshi N, Robinson, Hannah, Sanders, Helen, Sheehan, Emma, Smith, Holly, Snape, Matthew D, Song, Rinn, Woods, Danielle, Screaton, Gavin, Gilbert, Sarah C, Voysey, Merryn, Pollard, Andrew J, and Lambe, Teresa
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- 2021
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7. Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 in HIV infection: a single-arm substudy of a phase 2/3 clinical trial
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Watson, Marion E.E., Song, Rinn, Cicconi, Paola, Minassian, Angela M., Bibi, Sagida, Kerridge, Simon, Singh, Nisha, Green, Catherine M., Douglas, Alexander D., Lawrie, Alison M., Clutterbuck, Elizabeth A., Frater, John, Ewer, Katie J, Ogbe, Ane, Pace, Mathew, Adele, Sandra, Adland, Emily, Alagaratnam, Jasmini, Aley, Parvinder K, Ali, Mohammad, Ansari, M Azim, Bara, Anna, Bittaye, Mustapha, Broadhead, Samantha, Brown, Anthony, Brown, Helen, Cappuccini, Federica, Cooney, Enya, Dejnirattisai, Wanwisa, Dold, Christina, Fairhead, Cassandra, Fok, Henry, Folegatti, Pedro M, Fowler, Jamie, Gibbs, Charlotte, Goodman, Anna L, Jenkin, Daniel, Jones, Mathew, Makinson, Rebecca, Marchevsky, Natalie G, Mujadidi, Yama F, Nguyen, Hanna, Parolini, Lucia, Petersen, Claire, Plested, Emma, Pollock, Katrina M, Ramasamy, Maheshi N, Rhead, Sarah, Robinson, Hannah, Robinson, Nicola, Rongkard, Patpong, Ryan, Fiona, Serrano, Sonia, Tipoe, Timothy, Voysey, Merryn, Waters, Anele, Zacharopoulou, Panagiota, Barnes, Eleanor, Dunachie, Susanna, Goulder, Philip, Klenerman, Paul, Screaton, Gavin R, Winston, Alan, Hill, Adrian V S, Gilbert, Sarah C, Pollard, Andrew J, Fidler, Sarah, Fox, Julie, and Lambe, Teresa
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- 2021
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8. T cell and antibody responses induced by a single dose of ChAdOx1 nCoV-19 (AZD1222) vaccine in a phase 1/2 clinical trial
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Ewer, Katie J., Barrett, Jordan R., Belij-Rammerstorfer, Sandra, Sharpe, Hannah, Makinson, Rebecca, Morter, Richard, Flaxman, Amy, Alderson, Jennifer, Bittaye, Mustapha, Dold, Christina, Provine, Nicholas M., Aboagye, Jeremy, Fowler, Jamie, Silk, Sarah E., Aley, Parvinder K., Bellamy, Duncan, and Wright, Daniel
- Subjects
T cells -- Physiological aspects ,Biological sciences ,Health - Abstract
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of Coronavirus Disease 2019 (COVID-19), has caused a global pandemic, and safe, effective vaccines are urgently needed.sup.1. Strong, Th1-skewed T cell responses can drive protective humoral and cell-mediated immune responses.sup.2 and might reduce the potential for disease enhancement.sup.3. Cytotoxic T cells clear virus-infected host cells and contribute to control of infection.sup.4. Studies of patients infected with SARS-CoV-2 have suggested a protective role for both humoral and cell-mediated immune responses in recovery from COVID-19 (refs. .sup.5,6). ChAdOx1 nCoV-19 (AZD1222) is a candidate SARS-CoV-2 vaccine comprising a replication-deficient simian adenovirus expressing full-length SARS-CoV-2 spike protein. We recently reported preliminary safety and immunogenicity data from a phase 1/2 trial of the ChAdOx1 nCoV-19 vaccine (NCT04400838).sup.7 given as either a one- or two-dose regimen. The vaccine was tolerated, with induction of neutralizing antibodies and antigen-specific T cells against the SARS-CoV-2 spike protein. Here we describe, in detail, exploratory analyses of the immune responses in adults, aged 18-55 years, up to 8 weeks after vaccination with a single dose of ChAdOx1 nCoV-19 in this trial, demonstrating an induction of a Th1-biased response characterized by interferon-[gamma] and tumor necrosis factor-[alpha] cytokine secretion by CD4.sup.+ T cells and antibody production predominantly of IgG1 and IgG3 subclasses. CD8.sup.+ T cells, of monofunctional, polyfunctional and cytotoxic phenotypes, were also induced. Taken together, these results suggest a favorable immune profile induced by ChAdOx1 nCoV-19 vaccine, supporting the progression of this vaccine candidate to ongoing phase 2/3 trials to assess vaccine efficacy. A single dose of the ChAdOx1 nCoV-19 vaccine elicits antibodies and cytokine-producing T cells that might help control or prevent SARS-CoV-2 infection., Author(s): Katie J. Ewer [sup.1] , Jordan R. Barrett [sup.1] , Sandra Belij-Rammerstorfer [sup.1] , Hannah Sharpe [sup.1] , Rebecca Makinson [sup.1] , Richard Morter [sup.1] , Amy Flaxman [sup.1] [...]
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- 2021
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9. Phase 1/2 trial of SARS-CoV-2 vaccine ChAdOx1 nCoV-19 with a booster dose induces multifunctional antibody responses
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Barrett, Jordan R., Belij-Rammerstorfer, Sandra, Dold, Christina, Ewer, Katie J., Folegatti, Pedro M., Gilbride, Ciaran, Halkerston, Rachel, Hill, Jennifer, Jenkin, Daniel, Stockdale, Lisa, Verheul, Marije K., Aley, Parvinder K., Angus, Brian, Bellamy, Duncan, Berrie, Eleanor, Bibi, Sagida, and Bittaye, Mustapha
- Subjects
AstraZeneca PLC -- Product development ,Immune response -- Health aspects ,Viral antibodies -- Health aspects ,Antibodies -- Health aspects ,Pharmaceutical industry -- Product development ,Biological sciences ,Health ,AZD1222 (Vaccine) -- Physiological aspects -- Testing - Abstract
More than 190 vaccines are currently in development to prevent infection by the novel severe acute respiratory syndrome coronavirus 2. Animal studies suggest that while neutralizing antibodies against the viral spike protein may correlate with protection, additional antibody functions may also be important in preventing infection. Previously, we reported early immunogenicity and safety outcomes of a viral vector coronavirus vaccine, ChAdOx1 nCoV-19 (AZD1222), in a single-blinded phase 1/2 randomized controlled trial of healthy adults aged 18-55 years (NCT04324606). Now we describe safety and exploratory humoral and cellular immunogenicity of the vaccine, from subgroups of volunteers in that trial, who were subsequently allocated to receive a homologous full-dose (SD/SD D56; n = 20) or half-dose (SD/LD D56; n = 32) ChAdOx1 booster vaccine 56 d following prime vaccination. Previously reported immunogenicity data from the open-label 28-d interval prime-boost group (SD/SD D28; n = 10) are also presented to facilitate comparison. Additionally, we describe volunteers boosted with the comparator vaccine (MenACWY; n = 10). In this interim report, we demonstrate that a booster dose of ChAdOx1 nCoV-19 is safe and better tolerated than priming doses. Using a systems serology approach we also demonstrate that anti-spike neutralizing antibody titers, as well as Fc-mediated functional antibody responses, including antibody-dependent neutrophil/monocyte phagocytosis, complement activation and natural killer cell activation, are substantially enhanced by a booster dose of vaccine. A booster dose of vaccine induced stronger antibody responses than a dose-sparing half-dose boost, although the magnitude of T cell responses did not increase with either boost dose. These data support the two-dose vaccine regime that is now being evaluated in phase 3 clinical trials. Two doses of the coronavirus disease 2019 vaccine ChAdOx1 nCoV-19 boost antibody responses and functions in phase 1/2 trial participants., Author(s): Jordan R. Barrett [sup.1] , Sandra Belij-Rammerstorfer [sup.1] , Christina Dold [sup.2] , Katie J. Ewer [sup.1] , Pedro M. Folegatti [sup.1] , Ciaran Gilbride [sup.1] , Rachel Halkerston [...]
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- 2021
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10. A single dose of ChAdOx1 Chik vaccine induces neutralizing antibodies against four chikungunya virus lineages in a phase 1 clinical trial
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Folegatti, Pedro M., Harrison, Kate, Preciado-Llanes, Lorena, Lopez, Fernando Ramos, Bittaye, Mustapha, Kim, Young Chan, Flaxman, Amy, Bellamy, Duncan, Makinson, Rebecca, Sheridan, Jonathan, Azar, Sasha R., Campos, Rafael Kroon, Tilley, Mark, Tran, Nguyen, Jenkin, Daniel, Poulton, Ian, Lawrie, Alison, Roberts, Rachel, Berrie, Eleanor, Rossi, Shannan L., Hill, Adrian, Ewer, Katie J., and Reyes-Sandoval, Arturo
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- 2021
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11. Safety and immunogenicity of varied doses of R21/Matrix-M™ vaccine at three years follow-up: A phase 1b age de-escalation, dose-escalation trial in adults, children, and infants in Kilifi-Kenya
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Sang, Samuel, primary, Datoo, Mehreen S., additional, Otieno, Edward, additional, Muiruri, Charles, additional, Bellamy, Duncan, additional, Gathuri, Emmaloise, additional, Ngoto, Omar, additional, Musembi, Janet, additional, Provstgaard-Morys, Sam, additional, Stockdale, Lisa, additional, Aboagye, Jeremy, additional, Woods, Daniel, additional, Lawrie, Alison, additional, Roberts, Racheal, additional, Keter, Kelvias, additional, Kimani, Domtila, additional, Ndungu, Francis, additional, Kapulu, Melissa, additional, Njau, Irene, additional, Orindi, Benedict, additional, Ewer, Katie J., additional, Hill, Adrian V.S., additional, Bejon, Philip, additional, and Hamaluba, Mainga, additional
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- 2023
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12. A review of Phase I trials of Ebola virus vaccines: what can we learn from the race to develop novel vaccines?
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Lambe, Teresa, Bowyer, Georgina, and Ewer, Katie J
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- 2017
13. Correlations between three ELISA protocols measurements of RTS,S/AS01-induced anti-CSP IgG antibodies
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Mugo, Robert M., primary, Orindi, Benedict, additional, Shee, Faiz M., additional, Bellamy, Duncan, additional, Mwacharo, Jedidah, additional, Ewer, Katie J., additional, Bejon, Philip, additional, and Ndungu, Francis M., additional
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- 2023
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14. Safety and efficacy of malaria vaccine candidate R21/Matrix-M in African children: a multicentre, double-blind, randomised, phase 3 trial
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Datoo, Mehreen S, Dicko, Alassane, Tinto, Halidou, Ouédraogo, Jean-Bosco, Hamaluba, Mainga, Olotu, Ally, Beaumont, Emma, Ramos Lopez, Fernando, Natama, Hamtandi Magloire, Weston, Sophie, Chemba, Mwajuma, Compaore, Yves Daniel, Issiaka, Djibrilla, Salou, Diallo, Some, Athanase M, Omenda, Sharon, Lawrie, Alison, Bejon, Philip, Rao, Harish, Chandramohan, Daniel, Roberts, Rachel, Bharati, Sandesh, Stockdale, Lisa, Gairola, Sunil, Greenwood, Brian M, Ewer, Katie J, Bradley, John, Kulkarni, Prasad S, Shaligram, Umesh, Hill, Adrian V S, Mahamar, Almahamoudou, Sanogo, Koualy, Sidibe, Youssoufa, Diarra, Kalifa, Samassekou, Mamoudou, Attaher, Oumar, Tapily, Amadou, Diallo, Makonon, Dicko, Oumar Mohamed, Kaya, Mahamadou, Maguiraga, Seydina Oumar, Sankare, Yaya, Yalcouye, Hama, Diarra, Soumaila, Niambele, Sidi Mohamed, Thera, Ismaila, Sagara, Issaka, Sylla, Mala, Dolo, Amagana, Misidai, Nsajigwa, Simando, Sylvester, Msami, Hania, Juma, Omary, Gutapaka, Nicolaus, Paul, Rose, Mswata, Sarah, Sasamalo, Ibrahim, Johaness, Kasmir, Sultan, Mwantumu, Alexander, Annastazia, Kimaro, Isaac, Lwanga, Kauye, Mtungwe, Mwajuma, Khamis, Kassim, Rugarabam, Lighton, Kalinga, Wilmina, Mohammed, Mohammed, Kamange, Janeth, Msangi, Jubilate, Mwaijande, Batuli, Mtaka, Ivanny, Mhapa, Matilda, Mlaganile, Tarsis, Mbaga, Thabit, Yerbanga, Rakiswende Serge, Samtouma, Wendkouni, Sienou, Abdoul Aziz, Kabre, Zachari, Ouedraogo, Wendinpui Jedida Muriel, Yarbanga, G Armel Bienvenu, Zongo, Issaka, Savadogo, Hamade, Sanon, Joseph, Compaore, Judicael, Kere, Idrissa, Yoni, Ferdinand Lionel, Sanre, Tewende Martine, Ouattara, Seydou Bienvenu, Provstgaard-Morys, Samuel, Woods, Danielle, Snow, Robert W., Amek, Nyaguara, Ngetsa, Caroline J., Ochola-Oyier, Lynette Isabella, Musyoki, Jennifer, Munene, Marianne, Mumba, Noni, Adetifa, Uche Jane, Muiruri, Charles Mwangi, Mwawaka, Jimmy Shangala, Mwaganyuma, Mwatasa Hussein, Ndichu, Martha Njeri, Weya, Joseph Ochieng, Njogu, Kelvin, Grant, Jane, Webster, Jayne, Lakhkar, Anand, Ido, N. Félix André, Traore, Ousmane, Tahita, Marc Christian, Bonko, Massa dit Achille, Rouamba, Toussaint, Ouedraogo, D. Florence, Soma, Rachidatou, Millogo, Aida, Ouedraogo, Edouard, Sorgho, Faizatou, Konate, Fabé, and Valea, Innocent
- Abstract
Recently, we found that a new malaria vaccine, R21/Matrix-M, had over 75% efficacy against clinical malaria with seasonal administration in a phase 2b trial in Burkina Faso. Here, we report on safety and efficacy of the vaccine in a phase 3 trial enrolling over 4800 children across four countries followed for up to 18 months at seasonal sites and 12 months at standard sites.
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- 2024
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15. Cryopreservation-related loss of antigen-specific IFNγ producing CD4+ T-cells can skew immunogenicity data in vaccine trials: Lessons from a malaria vaccine trial substudy
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Ford, Tom, Wenden, Claire, Mbekeani, Alison, Dally, Len, Cox, Josephine H., Morin, Merribeth, Winstone, Nicola, Hill, Adrian V.S., Gilmour, Jill, and Ewer, Katie J.
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- 2017
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16. A tool for evaluating heterogeneity in avidity of polyclonal antibodies
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Li, Kan, primary, Dodds, Michael, additional, Spreng, Rachel L., additional, Abraha, Milite, additional, Huntwork, Richard H. C., additional, Dahora, Lindsay C., additional, Nyanhete, Tinashe, additional, Dutta, Sheetij, additional, Wille-Reece, Ulrike, additional, Jongert, Erik, additional, Ewer, Katie J., additional, Hill, Adrian V. S., additional, Jin, Celina, additional, Hill, Jennifer, additional, Pollard, Andrew J., additional, Munir Alam, S., additional, Tomaras, Georgia D., additional, and Dennison, S. Moses, additional
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- 2023
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17. Persistence of the immune response after two doses of ChAdOx1 nCov-19 (AZD1222): 1 year of follow-up of two randomized controlled trials
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Voysey, Merryn, primary, Flaxman, Amy, additional, Aboagye, Jeremy, additional, Aley, Parvinder K, additional, Belij-Rammerstorfer, Sandra, additional, Bibi, Sagida, additional, Bittaye, Mustapha, additional, Cappuccini, Federica, additional, Charlton, Sue, additional, Clutterbuck, Elizabeth A, additional, Davies, Sophie, additional, Dold, Christina, additional, Edwards, Nick J, additional, Ewer, Katie J, additional, Faust, Saul N, additional, Folegatti, Pedro M, additional, Fowler, Jamie, additional, Gilbride, Ciaran, additional, Gilbert, Sarah C, additional, Godfrey, Leila, additional, Hallis, Bassam, additional, Humphries, Holly E, additional, Jenkin, Daniel, additional, Kerridge, Simon, additional, Mujadidi, Yama F, additional, Plested, Emma, additional, Ramasamy, Maheshi N, additional, Robinson, Hannah, additional, Sanders, Helen, additional, Snape, Matthew D, additional, Song, Rinn, additional, Thomas, Kelly M, additional, Ulaszewska, Marta, additional, Woods, Danielle, additional, Wright, Daniel, additional, Pollard, Andrew J, additional, and Lambe, Teresa, additional
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- 2023
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18. Safety and High Level Efficacy of the Combination Malaria Vaccine Regimen of RTS,S/AS01 B With Chimpanzee Adenovirus 63 and Modified Vaccinia Ankara Vectored Vaccines Expressing ME-TRAP
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Rampling, Tommy, Ewer, Katie J., Bowyer, Georgina, Bliss, Carly M., Edwards, Nick J., Wright, Danny, Payne, Ruth O., Venkatraman, Navin, de Barra, Eoghan, Snudden, Claudia M., Poulton, Ian D., de Graaf, Hans, Sukhtankar, Priya, Roberts, Rachel, Ivinson, Karen, Weltzin, Rich, Rajkumar, Bebi-Yassin, Wille-Reece, Ulrike, Lee, Cynthia K., Ockenhouse, Christian F., Sinden, Robert E., Gerry, Stephen, Lawrie, Alison M., Vekemans, Johan, Morelle, Danielle, Lievens, Marc, Ballou, Ripley W., Cooke, Graham S., Faust, Saul N., Gilbert, Sarah, and Hill, Adrian V. S.
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- 2016
19. Progress with viral vectored malaria vaccines: A multi-stage approach involving “unnatural immunity”
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Ewer, Katie J., Sierra-Davidson, Kailan, Salman, Ahmed M., Illingworth, Joseph J., Draper, Simon J., Biswas, Sumi, and Hill, Adrian V.S.
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- 2015
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20. A Phase 1b Clinical Trial to Determine the Safety, Tolerability and Immunogenicity of the Candidate Mycobacterium Avium Complex Subspecies Vaccines ChAdOx2 HAV and MVA HAV in Patients with Active Crohn's Disease
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Sanderson, Jeremy, primary, Aboagye, Jeremy, additional, Makinson, Rebecca, additional, Rapi, Katerina, additional, Provstgaard-Morys, Samuel, additional, Stockdale, Lisa, additional, Lawrie, Alison M., additional, Lanigan, Isabelle, additional, Halim, Nishat, additional, Douiri, Abdel, additional, Greenlay, Emily, additional, Malek, Rayka, additional, Gray, Emma, additional, West, Lindsey, additional, El Oulidi, Fatima, additional, Cross, Paul Ian, additional, Stallibrass, Michael, additional, Gilbert, Sarah C., additional, Hill, Adrian V. S., additional, and Ewer, Katie J., additional
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- 2023
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21. Impact of exposure to malaria and nutritional status on responses to the experimental malaria vaccine ChAd63 MVA ME-TRAP in 5-17 month-old children in Burkina Faso
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Morter, Richard, primary, Tiono, Alfred B., additional, Nébié, Issa, additional, Hague, Oliver, additional, Ouedraogo, Alphonse, additional, Diarra, Amidou, additional, Viebig, Nicola K., additional, Hill, Adrian V. S., additional, Ewer, Katie J., additional, and Sirima, Sodiomon B., additional
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- 2022
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22. Tolerability and immunogenicity of an intranasally-administered adenovirus-vectored COVID-19 vaccine: An open-label partially-randomised ascending dose phase I trial
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Madhavan, Meera, primary, Ritchie, Adam J., additional, Aboagye, Jeremy, additional, Jenkin, Daniel, additional, Provstgaad-Morys, Samuel, additional, Tarbet, Iona, additional, Woods, Danielle, additional, Davies, Sophie, additional, Baker, Megan, additional, Platt, Abigail, additional, Flaxman, Amy, additional, Smith, Holly, additional, Belij-Rammerstorfer, Sandra, additional, Wilkins, Deidre, additional, Kelly, Elizabeth J., additional, Villafana, Tonya, additional, Green, Justin A., additional, Poulton, Ian, additional, Lambe, Teresa, additional, Hill, Adrian V.S., additional, Ewer, Katie J., additional, and Douglas, Alexander D., additional
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- 2022
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23. Evaluation of the Efficacy of ChAd63-MVA Vectored Vaccines Expressing Circumsporozoite Protein and ME-TRAP Against Controlled Human Malaria Infection in Malaria-Naive Individuals
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Hodgson, Susanne H., Ewer, Katie J., Bliss, Carly M., Edwards, Nick J., Rampling, Thomas, Anagnostou, Nicholas A., de Barra, Eoghan, Havelock, Tom, Bowyer, Georgina, Poulton, Ian D., de Cassan, Simone, Longley, Rhea, Illingworth, Joseph J., Douglas, Alexander D., Mange, Pooja B., Collins, Katharine A., Roberts, Rachel, Gerry, Stephen, Berrie, Eleanor, Moyle, Sarah, Colloca, Stefano, Cortese, Riccardo, Sinden, Robert E., Gilbert, Sarah C., Bejon, Philip, Lawrie, Alison M., Nicosia, Alfredo, Faust, Saul N., and Hill, Adrian V. S.
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- 2015
24. Safety and efficacy of novel malaria vaccine regimens of RTS,S/AS01B alone, or with concomitant ChAd63-MVA-vectored vaccines expressing ME-TRAP
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Rampling, Tommy, Ewer, Katie J., Bowyer, Georgina, Edwards, Nick J., Wright, Danny, Sridhar, Saranya, Payne, Ruth, Powlson, Jonathan, Bliss, Carly, Venkatraman, Navin, Poulton, Ian D., de Graaf, Hans, Gbesemete, Diane, Grobbelaar, Amy, Davies, Huw, Roberts, Rachel, Angus, Brian, Ivinson, Karen, Weltzin, Rich, Rajkumar, Bebi-Yassin, Wille-Reece, Ulrike, Lee, Cynthia, Ockenhouse, Chris, Sinden, Robert E., Gerry, Stephen C., Lawrie, Alison M., Vekemans, Johan, Morelle, Danielle, Lievens, Marc, Ballou, Ripley W., Lewis, David J. M., Cooke, Graham S., Faust, Saul N., Gilbert, Sarah, and Hill, Adrian V. S
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- 2018
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25. Clinical Assessment of a Recombinant Simian Adenovirus ChAd63: A Potent New Vaccine Vector
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O'Hara, Geraldine A., Duncan, Christopher J. A., Ewer, Katie J., Collins, Katharine A., Elias, Sean C., Halstead, Fenella D., Goodman, Anna L., Edwards, Nick J., Reyes-Sandoval, Arturo, Bird, Prudence, Rowland, Rosalind, Sheehy, Susanne H., Poulton, Ian D., Hutchings, Claire, Todryk, Stephen, Andrews, Laura, Folgori, Antonella, Berrie, Eleanor, Moyle, Sarah, Nicosia, Alfredo, Colloca, Stefano, Cortese, Riccardo, Siani, Loredana, Lawrie, Alison M., Gilbert, Sarah C., and Hill, Adrian V. S.
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- 2012
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26. Durability of ChAdOx1 nCoV-19 vaccination in people living with HIV
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Ogbe, Ane, primary, Pace, Matthew, additional, Bittaye, Mustapha, additional, Tipoe, Timothy, additional, Adele, Sandra, additional, Alagaratnam, Jasmini, additional, Aley, Parvinder K., additional, Ansari, M. Azim, additional, Bara, Anna, additional, Broadhead, Samantha, additional, Brown, Anthony, additional, Brown, Helen, additional, Cappuccini, Federica, additional, Cinardo, Paola, additional, Dejnirattisai, Wanwisa, additional, Ewer, Katie J., additional, Fok, Henry, additional, Folegatti, Pedro M., additional, Fowler, Jamie, additional, Godfrey, Leila, additional, Goodman, Anna L., additional, Jackson, Bethany, additional, Jenkin, Daniel, additional, Jones, Mathew, additional, Longet, Stephanie, additional, Makinson, Rebecca A., additional, Marchevsky, Natalie G., additional, Mathew, Moncy, additional, Mazzella, Andrea, additional, Mujadidi, Yama F., additional, Parolini, Lucia, additional, Petersen, Claire, additional, Plested, Emma, additional, Pollock, Katrina M., additional, Rajeswaran, Thurkka, additional, Ramasamy, Maheshi N., additional, Rhead, Sarah, additional, Robinson, Hannah, additional, Robinson, Nicola, additional, Sanders, Helen, additional, Serrano, Sonia, additional, Tipton, Tom, additional, Waters, Anele, additional, Zacharopoulou, Panagiota, additional, Barnes, Eleanor, additional, Dunachie, Susanna, additional, Goulder, Philip, additional, Klenerman, Paul, additional, Screaton, Gavin R., additional, Winston, Alan, additional, Hill, Adrian V.S., additional, Gilbert, Sarah C., additional, Carroll, Miles, additional, Pollard, Andrew J., additional, Fidler, Sarah, additional, Fox, Julie, additional, Lambe, Teresa, additional, and Frater, John, additional
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- 2022
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27. CMV-associated T cell and NK cell terminal differentiation does not affect immunogenicity of ChAdOx1 vaccination
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Sharpe, Hannah R., primary, Provine, Nicholas M., additional, Bowyer, Georgina S., additional, Moreira Folegatti, Pedro, additional, Belij-Rammerstorfer, Sandra, additional, Flaxman, Amy, additional, Makinson, Rebecca, additional, Hill, Adrian V.S., additional, Ewer, Katie J., additional, Pollard, Andrew J., additional, Klenerman, Paul, additional, Gilbert, Sarah, additional, and Lambe, Teresa, additional
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- 2022
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28. Deep Immune Phenotyping and Single-Cell Transcriptomics Allow Identification of Circulating TRM-Like Cells Which Correlate With Liver-Stage Immunity and Vaccine-Induced Protection From Malaria
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Noé, Andrés, primary, Datoo, Mehreen S., additional, Flaxman, Amy, additional, Husainy, Mohammad Ali, additional, Jenkin, Daniel, additional, Bellamy, Duncan, additional, Makinson, Rebecca A., additional, Morter, Richard, additional, Ramos Lopez, Fernando, additional, Sheridan, Jonathan, additional, Voukantsis, Dimitrios, additional, Prasad, Naveen, additional, Hill, Adrian V. S., additional, Ewer, Katie J., additional, and Spencer, Alexandra J., additional
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- 2022
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29. Reactogenicity and immunogenicity after a late second dose or a third dose of ChAdOx1 nCoV-19 in the UK: a substudy of two randomised controlled trials (COV001 and COV002)
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Flaxman, Amy, Marchevsky, Natalie G, Jenkin, Daniel, Aboagye, Jeremy, Aley, Parvinder K, Angus, Brian, Belij-Rammerstorfer, Sandra, Bibi, Sagida, Bittaye, Mustapha, Cappuccini, Federica, Cicconi, Paola, Clutterbuck, Elizabeth A, Davies, Sophie, Dejnirattisai, Wanwisa, Dold, Christina, Ewer, Katie J, Folegatti, Pedro M, Fowler, Jamie, Hill, Adrian VS, Kerridge, Simon, Minassian, Angela M, Mongkolsapaya, Juthathip, Mujadidi, Yama F, Plested, Emma, Ramasamy, Maheshi N, Robinson, Hannah, Sanders, Helen, Sheehan, Emma, Smith, Holly, Snape, Matthew D, Song, Rinn, Woods, Danielle, Screaton, Gavin, Gilbert, Sarah C, Voysey, Merryn, Pollard, Andrew J, Lambe, Teresa, and Oxford COVID Vaccine Trial group
- Abstract
BACKGROUND: COVID-19 vaccine supply shortages are causing concerns about compromised immunity in some countries as the interval between the first and second dose becomes longer. Conversely, countries with no supply constraints are considering administering a third dose. We assessed the persistence of immunogenicity after a single dose of ChAdOx1 nCoV-19 (AZD1222), immunity after an extended interval (44-45 weeks) between the first and second dose, and response to a third dose as a booster given 28-38 weeks after the second dose. METHODS: In this substudy, volunteers aged 18-55 years who were enrolled in the phase 1/2 (COV001) controlled trial in the UK and had received either a single dose or two doses of 5 × 1010 viral particles were invited back for vaccination. Here we report the reactogenicity and immunogenicity of a delayed second dose (44-45 weeks after first dose) or a third dose of the vaccine (28-38 weeks after second dose). Data from volunteers aged 18-55 years who were enrolled in either the phase 1/2 (COV001) or phase 2/3 (COV002), single-blinded, randomised controlled trials of ChAdOx1 nCoV-19 and who had previously received a single dose or two doses of 5 × 1010 viral particles are used for comparison purposes. COV001 is registered with ClinicalTrials.gov, NCT04324606, and ISRCTN, 15281137, and COV002 is registered with ClinicalTrials.gov, NCT04400838, and ISRCTN, 15281137, and both are continuing but not recruiting. FINDINGS: Between March 11 and 21, 2021, 90 participants were enrolled in the third-dose boost substudy, of whom 80 (89%) were assessable for reactogenicity, 75 (83%) were assessable for evaluation of antibodies, and 15 (17%) were assessable for T-cells responses. The two-dose cohort comprised 321 participants who had reactogenicity data (with prime-boost interval of 8-12 weeks: 267 [83%] of 321; 15-25 weeks: 24 [7%]; or 44-45 weeks: 30 [9%]) and 261 who had immunogenicity data (interval of 8-12 weeks: 115 [44%] of 261; 15-25 weeks: 116 [44%]; and 44-45 weeks: 30 [11%]). 480 participants from the single-dose cohort were assessable for immunogenicity up to 44-45 weeks after vaccination. Antibody titres after a single dose measured approximately 320 days after vaccination remained higher than the titres measured at baseline (geometric mean titre of 66·00 ELISA units [EUs; 95% CI 47·83-91·08] vs 1·75 EUs [1·60-1·93]). 32 participants received a late second dose of vaccine 44-45 weeks after the first dose, of whom 30 were included in immunogenicity and reactogenicity analyses. Antibody titres were higher 28 days after vaccination in those with a longer interval between first and second dose than for those with a short interval (median total IgG titre: 923 EUs [IQR 525-1764] with an 8-12 week interval; 1860 EUs [917-4934] with a 15-25 week interval; and 3738 EUs [1824-6625] with a 44-45 week interval). Among participants who received a third dose of vaccine, antibody titres (measured in 73 [81%] participants for whom samples were available) were significantly higher 28 days after a third dose (median total IgG titre: 3746 EUs [IQR 2047-6420]) than 28 days after a second dose (median 1792 EUs [IQR 899-4634]; Wilcoxon signed rank test p=0·0043). T-cell responses were also boosted after a third dose (median response increased from 200 spot forming units [SFUs] per million peripheral blood mononuclear cells [PBMCs; IQR 127-389] immediately before the third dose to 399 SFUs per milion PBMCs [314-662] by day 28 after the third dose; Wilcoxon signed rank test p=0·012). Reactogenicity after a late second dose or a third dose was lower than reactogenicity after a first dose. INTERPRETATION: An extended interval before the second dose of ChAdOx1 nCoV-19 leads to increased antibody titres. A third dose of ChAdOx1 nCoV-19 induces antibodies to a level that correlates with high efficacy after second dose and boosts T-cell responses. FUNDING: UK Research and Innovation, Engineering and Physical Sciences Research Council, National Institute for Health Research, Coalition for Epidemic Preparedness Innovations, National Institute for Health Research Oxford Biomedical Research Centre, Chinese Academy of Medical Sciences Innovation Fund for Medical Science, Thames Valley and South Midlands NIHR Clinical Research Network, AstraZeneca, and Wellcome.
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- 2021
30. T-cell mediated immunity after AZD1222 vaccination: A polyfunctional spike-specific Th1 response with a diverse TCR repertoire
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Swanson, Phillip A., Padilla, Marcelino, Hoyland, Wesley, McGlinchey, Kelly, Fields, Paul A., Bibi, Sagida, Faust, Saul N., McDermott, Adrian B., Lambe, Teresa, Pollard, Andrew J., Durham, Nicholas M., Kelly, Elizabeth J., Adlou, Syed, Aley, Parvinder K., Angus, Brian, Anslow, Rachel, Baker, Philip, Bansal, Himanshu, Beveridge, Amy, Bridges-Webb, Alice, Ching, Steven, Cicconi, Paola, Clutterbuck, Elizabeth A., Collins, Andrea M., Darton, Thomas C., Demissie, Tesfaye, Dinesh, Tanya, Douglas, Alexander D., Duncan, Christopher J. A., Ewer, Katie J., Felle, Sally, Finn, Adam, Folegatti, Pedro M., Fuskova, Michelle, Gilbert, Sarah C., Goodman, Anna, Green, Christopher A., Harbolick, Elizabeth, Hart, Thomas C., Hayes, Susana, Hill, Adrian V. S., Jenkin, Daniel, Jepson, Brett M., Kasanyinga, Mwila, Kerridge, Simon, Libri, Vincenzo, Lillie, Patrick J., McGregor, Alastair C., Minassian, Angela M., Mujadidi, Yama F., Pilataxi, Fernanda, Plested, Emma, Provstgaard-Morys, Samuel, Ramasamy, Maheshi, Robinson, Hannah, Sanders, Katherine, Smith, Andrew, Snape, Matthew D., Song, Rinn, Sutherland, Rebecca K., Thomson, Emma C., Toshner, Mark, Turner, David P. J., Voysey, Merryn, and Williams, Christopher J.
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COVID-19 Vaccines ,SARS-CoV-2 ,Immunogenicity ,T cell ,Vaccination ,T-cell receptor ,Receptors, Antigen, T-Cell ,COVID-19 ,Biology ,Peripheral blood mononuclear cell ,Article ,T cell mediated immunity ,medicine.anatomical_structure ,ChAdOx1 nCoV-19 ,Spike Glycoprotein, Coronavirus ,Immunology ,medicine ,Humans ,Receptor ,CD8 - Abstract
AZD1222 (ChAdOx1 nCoV-19), a replication-deficient simian adenovirus-vectored vaccine, has demonstrated safety, efficacy, and immunogenicity against coronavirus disease 2019 (COVID-19) in clinical trials and real-world studies. We characterized CD4+ and CD8+ T-cell responses induced by AZD1222 vaccination in peripheral blood mononuclear cells (PBMCs) from 280 unique vaccine recipients aged 18–85 years who enrolled in the phase 2/3 COV002 trial. Total spike-specific CD4+ T cell helper type 1 (Th1) and CD8+ T-cell responses were significantly increased in AZD1222-vaccinated adults of all ages following two doses of AZD1222. CD4+ Th2 responses following AZD1222 vaccination were not detected. Furthermore, AZD1222-specific Th1 and CD8+ T cells both displayed a high degree of polyfunctionality in all adult age groups. T-cell receptor (TCR) β sequences from vaccinated participants mapped against TCR sequences known to react to SARS-CoV-2 revealed substantial breadth and depth across the SARS-CoV-2 spike protein for the AZD1222-induced CD4+ and CD8+ T-cell responses. Overall, AZD1222 vaccination induced a robust, polyfunctional Th1-dominated T-cell response, with broad CD4+ and CD8+ T-cell coverage across the SARS-CoV-2 spike protein.One Sentence SummaryPolyfunctional CD4+ and CD8+ T-cell responses are elicited against the SARS-CoV-2 spike protein following vaccination with AZD1222
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- 2021
31. Efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 VOC 202012/01 (B.1.1.7), an exploratory analysis of a randomised controlled trial
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Emary, Katherine RW, Golubchik, Tanya, Aley, Parvinder K, Ariani, Cristina V, Angus, Brian, Bibi, Sagida, Blane, Beth, Bonsall, David, Cicconi, Paola, Charlton, Sue, Clutterbuck, Elizabeth A, Collins, Andrea M, Cox, Tony, Darton, Thomas C, Dold, Christina, Douglas, Alexander D, Duncan, Christopher JA, Ewer, Katie J, Flaxman, Amy L, Faust, Saul N, Ferreir, Daniela M, Feng, Shuo, Finn, Adam, Folegatti, Pedro M, Fuskova, Michelle, Galiza, Eva, Goodman, Anna L, Green, Catherine M, Green, Christopher A, Greenland, Melanie, Hallis, Bassam, Heath, Paul T, Hay, Jodie, Hill, Helen C, Jenkin, Daniel, Kerridge, Simon, Lazarus, Rajeka, Libri, Vincenzo, Lillie, Patrick J, Ludden, Catherine, Marchevsky, Natalie G, Minassian, Angela M, McGregor, Alastair C, Mujadidi, Yama F, Phillips, Daniel J, Plested, Emma, Pollock, Katrina M, Robinson, Hannah, Smith, Andrew, Song, Rinn, Snape, Matthew D, Sutherland, Rebecca K, Thomson, Emma C, Toshner, Mark, Turner, David PJ, Vekemans, Johan, Villafana, Tonya L, Williams, Christopher J, Hill, Adrian VS, Lambe, Teresa, Gilbert, Sarah C, Voysey, Merryn, Ramasamy, Maheshi N, Pollard, Andrew J, Consortium, The COVID-19 Genomics UK, Project, The AMPHEUS, Group, The Oxford COVID-19 Vaccine Trial, Toshner, Mark [0000-0002-3969-6143], and Apollo - University of Cambridge Repository
- Abstract
A new variant of SARS-CoV-2, B.1.1.7, emerged as the dominant cause of COVID-19 disease in the United Kingdom from November 2020. Here we report efficacy of the adenoviral vector vaccine, ChAdOx1 nCoV-19, against this variant., COVID-19 Genomics UK is supported by funding from the Medical Research Council, part of UK Research and Innovation, the NIHR, and Genome Research, operating as the Wellcome Sanger Institute.
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- 2021
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32. Durability of ChAdOx1 nCov-19 (AZD1222) vaccination in people living with HIV - responses to SARS-CoV-2, variants of concern and circulating coronaviruses
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Ogbe, Ane, primary, Pace, Mathew, additional, Bittaye, Mustapha, additional, Tipoe, Timothy, additional, Adele, Sandra, additional, Alagaratnam, Jasmini, additional, Aley, Parvinder K, additional, Ansari, M. Azim, additional, Bara, Anna, additional, Broadhead, Samantha, additional, Brown, Anthony, additional, Brown, Helen, additional, Cappuccini, Federica, additional, Cinardo, Paola, additional, Dejnirattisai, Wanwisa, additional, Ewer, Katie J., additional, Fok, Henry, additional, Folegatti, Pedro M., additional, Fowler, Jamie, additional, Godfrey, Leila, additional, Goodman, Anna L., additional, Jackson, Bethany, additional, Jenkin, Daniel, additional, Jones, Mathew, additional, Longet, Stephanie, additional, Makinson, Rebecca, additional, Marchevsky, Natalie G., additional, Mathew, Moncy, additional, Mazzella, Andrea, additional, Mujadidi, Yama F., additional, Parolini, Lucia, additional, Petersen, Claire, additional, Plested, Emma, additional, Pollock, Katrina M., additional, Rajeswaran, Thurkka, additional, Ramasamy, Maheshi N., additional, Rhead, Sarah, additional, Robinson, Hannah, additional, Robinson, Nicola, additional, Sanders, Helen, additional, Serrano, Sonia, additional, Stockmann, Helen, additional, Tipton, Tom, additional, Waters, Anele, additional, Zacharopoulou, Panagiota, additional, Barnes, Eleanor, additional, Dunachie, Susanna, additional, Goulder, Philip, additional, Klenerman, Paul, additional, Screaton, Gavin R., additional, Winston, Alan, additional, Hill, Adrian V. S., additional, Gilbert, Sarah C., additional, Carroll, Miles, additional, Pollard, Andrew J, additional, Fidler, Sarah, additional, Fox, Julie, additional, Lambe, Teresa, additional, and Frater, John, additional
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- 2021
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33. Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 in HIV infection: a single-arm substudy of a phase 2/3 clinical trial
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Frater, John, primary, Ewer, Katie J, additional, Ogbe, Ane, additional, Pace, Mathew, additional, Adele, Sandra, additional, Adland, Emily, additional, Alagaratnam, Jasmini, additional, Aley, Parvinder K, additional, Ali, Mohammad, additional, Ansari, M Azim, additional, Bara, Anna, additional, Bittaye, Mustapha, additional, Broadhead, Samantha, additional, Brown, Anthony, additional, Brown, Helen, additional, Cappuccini, Federica, additional, Cooney, Enya, additional, Dejnirattisai, Wanwisa, additional, Dold, Christina, additional, Fairhead, Cassandra, additional, Fok, Henry, additional, Folegatti, Pedro M, additional, Fowler, Jamie, additional, Gibbs, Charlotte, additional, Goodman, Anna L, additional, Jenkin, Daniel, additional, Jones, Mathew, additional, Makinson, Rebecca, additional, Marchevsky, Natalie G, additional, Mujadidi, Yama F, additional, Nguyen, Hanna, additional, Parolini, Lucia, additional, Petersen, Claire, additional, Plested, Emma, additional, Pollock, Katrina M, additional, Ramasamy, Maheshi N, additional, Rhead, Sarah, additional, Robinson, Hannah, additional, Robinson, Nicola, additional, Rongkard, Patpong, additional, Ryan, Fiona, additional, Serrano, Sonia, additional, Tipoe, Timothy, additional, Voysey, Merryn, additional, Waters, Anele, additional, Zacharopoulou, Panagiota, additional, Barnes, Eleanor, additional, Dunachie, Susanna, additional, Goulder, Philip, additional, Klenerman, Paul, additional, Screaton, Gavin R, additional, Winston, Alan, additional, Hill, Adrian V S, additional, Gilbert, Sarah C, additional, Pollard, Andrew J, additional, Fidler, Sarah, additional, Fox, Julie, additional, Lambe, Teresa, additional, Watson, Marion E.E., additional, Song, Rinn, additional, Cicconi, Paola, additional, Minassian, Angela M., additional, Bibi, Sagida, additional, Kerridge, Simon, additional, Singh, Nisha, additional, Green, Catherine M., additional, Douglas, Alexander D., additional, Lawrie, Alison M., additional, and Clutterbuck, Elizabeth A., additional
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- 2021
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34. Author Correction: Phase 1/2 trial of SARS-CoV-2 vaccine ChAdOx1 nCoV-19 with a booster dose induces multifunctional antibody responses
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Barrett, Jordan R., Belij-Rammerstorfer, Sandra, Dold, Christina, Ewer, Katie J., Folegatti, Pedro M., Gilbride, Ciaran, and Halkerston, Rachel
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Biological sciences ,Health - Abstract
A Correction to this paper has been published: https://doi.org/10.1038/s41591-021-01372-z., Author(s): Jordan R. Barrett [sup.1] , Sandra Belij-Rammerstorfer [sup.1] , Christina Dold [sup.2] , Katie J. Ewer [sup.1] , Pedro M. Folegatti [sup.1] , Ciaran Gilbride [sup.1] , Rachel Halkerston [...]
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- 2021
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35. Author Correction: T cell and antibody responses induced by a single dose of ChAdOx1 nCoV-19 (AZD1222) vaccine in a phase 1/2 clinical trial
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Ewer, Katie J., Barrett, Jordan R., Belij-Rammerstorfer, Sandra, Sharpe, Hannah, Makinson, Rebecca, Morter, Richard, and Flaxman, Amy
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Biological sciences ,Health - Abstract
Author(s): Katie J. Ewer [sup.1] , Jordan R. Barrett [sup.1] , Sandra Belij-Rammerstorfer [sup.1] , Hannah Sharpe [sup.1] , Rebecca Makinson [sup.1] , Richard Morter [sup.1] , Amy Flaxman [sup.1] [...]
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- 2021
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36. Efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 variant of concern 202012/01 (B.1.1.7): an exploratory analysis of a randomised controlled trial
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Emary, Katherine RW, Golubchik, Tanya, Aley, Parvinder K, Ariani, Cristina V, Angus, Brian, Bibi, Sagida, Blane, Beth, Bonsall, David, Cicconi, Paola, Charlton, Sue, Clutterbuck, Elizabeth A, Collins, Andrea M, Cox, Tony, Darton, Thomas C, Dold, Christina, Douglas, Alexander D, Duncan, Christopher JA, Ewer, Katie J, Flaxman, Amy L, Faust, Saul N, Ferreira, Daniela M, Feng, Shuo, Finn, Adam, Folegatti, Pedro M, Fuskova, Michelle, Galiza, Eva, Goodman, Anna L, Green, Catherine M, Green, Christopher A, Greenland, Melanie, Hallis, Bassam, Heath, Paul T, Hay, Jodie, Hill, Helen C, Jenkin, Daniel, Kerridge, Simon, Lazarus, Rajeka, Libri, Vincenzo, Lillie, Patrick J, Ludden, Catherine, Marchevsky, Natalie G, Minassian, Angela M, McGregor, Alastair C, Mujadidi, Yama F, Phillips, Daniel J, Plested, Emma, Pollock, Katrina M, Robinson, Hannah, Smith, Andrew, Song, Rinn, Snape, Matthew D, Sutherland, Rebecca K, Thomson, Emma C, Toshner, Mark, Turner, David PJ, Vekemans, Johan, Villafana, Tonya L, Williams, Christopher J, Hill, Adrian VS, Lambe, Teresa, Gilbert, Sarah C, Voysey, Merryn, Ramasamy, Maheshi N, Pollard, Andrew J, COVID-19 Genomics UK Consortium, AMPHEUS Project, Oxford COVID-19 Vaccine Trial Group, Toshner, Mark [0000-0002-3969-6143], and Apollo - University of Cambridge Repository
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Adult ,Male ,COVID-19 Vaccines ,Adolescent ,SARS-CoV-2 ,COVID-19 ,Middle Aged ,Viral Load ,Antibodies, Neutralizing ,United Kingdom ,Young Adult ,COVID-19 Nucleic Acid Testing ,ChAdOx1 nCoV-19 ,Humans ,Female ,Single-Blind Method ,Nucleic Acid Amplification Techniques ,Pandemics - Abstract
BACKGROUND: A new variant of SARS-CoV-2, B.1.1.7, emerged as the dominant cause of COVID-19 disease in the UK from November, 2020. We report a post-hoc analysis of the efficacy of the adenoviral vector vaccine, ChAdOx1 nCoV-19 (AZD1222), against this variant. METHODS: Volunteers (aged ≥18 years) who were enrolled in phase 2/3 vaccine efficacy studies in the UK, and who were randomly assigned (1:1) to receive ChAdOx1 nCoV-19 or a meningococcal conjugate control (MenACWY) vaccine, provided upper airway swabs on a weekly basis and also if they developed symptoms of COVID-19 disease (a cough, a fever of 37·8°C or higher, shortness of breath, anosmia, or ageusia). Swabs were tested by nucleic acid amplification test (NAAT) for SARS-CoV-2 and positive samples were sequenced through the COVID-19 Genomics UK consortium. Neutralising antibody responses were measured using a live-virus microneutralisation assay against the B.1.1.7 lineage and a canonical non-B.1.1.7 lineage (Victoria). The efficacy analysis included symptomatic COVID-19 in seronegative participants with a NAAT positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to vaccine received. Vaccine efficacy was calculated as 1 - relative risk (ChAdOx1 nCoV-19 vs MenACWY groups) derived from a robust Poisson regression model. This study is continuing and is registered with ClinicalTrials.gov, NCT04400838, and ISRCTN, 15281137. FINDINGS: Participants in efficacy cohorts were recruited between May 31 and Nov 13, 2020, and received booster doses between Aug 3 and Dec 30, 2020. Of 8534 participants in the primary efficacy cohort, 6636 (78%) were aged 18-55 years and 5065 (59%) were female. Between Oct 1, 2020, and Jan 14, 2021, 520 participants developed SARS-CoV-2 infection. 1466 NAAT positive nose and throat swabs were collected from these participants during the trial. Of these, 401 swabs from 311 participants were successfully sequenced. Laboratory virus neutralisation activity by vaccine-induced antibodies was lower against the B.1.1.7 variant than against the Victoria lineage (geometric mean ratio 8·9, 95% CI 7·2-11·0). Clinical vaccine efficacy against symptomatic NAAT positive infection was 70·4% (95% CI 43·6-84·5) for B.1.1.7 and 81·5% (67·9-89·4) for non-B.1.1.7 lineages. INTERPRETATION: ChAdOx1 nCoV-19 showed reduced neutralisation activity against the B.1.1.7 variant compared with a non-B.1.1.7 variant in vitro, but the vaccine showed efficacy against the B.1.1.7 variant of SARS-CoV-2. FUNDING: UK Research and Innovation, National Institute for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midlands NIHR Clinical Research Network, and AstraZeneca.
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- 2021
37. Single-dose administration and the influence of the timing of the booster dose on immunogenicity and efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine: a pooled analysis of four randomised trials
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Voysey, Merryn, Costa Clemens, Sue Ann, Madhi, Shabir A, Weckx, Lily Y, Folegatti, Pedro M, Aley, Parvinder K, Angus, Brian, Baillie, Vicky L, Barnabas, Shaun L, Bhorat, Qasim E, Bibi, Sagida, Briner, Carmen, Cicconi, Paola, Clutterbuck, Elizabeth A, Collins, Andrea M, Cutland, Clare L, Darton, Thomas C, Dheda, Keertan, Dold, Christina, Duncan, Christopher JA, Emary, Katherine RW, Ewer, Katie J, Flaxman, Amy, Fairlie, Lee, Faust, Saul N, Feng, Shuo, Ferreira, Daniela M, Finn, Adam, Galiza, Eva, Goodman, Anna L, Green, Catherine M, Green, Christopher A, Greenland, Melanie, Hill, Catherine, Hill, Helen C, Hirsch, Ian, Izu, Alane, Jenkin, Daniel, Joe, Carina CD, Kerridge, Simon, Koen, Anthonet, Kwatra, Gaurav, Lazarus, Rajeka, Libri, Vincenzo, Lillie, Patrick J, Marchevsky, Natalie G, Marshall, Richard P, Mendes, Ana VA, Milan, Eveline P, Minassian, Angela M, McGregor, Alastair, Mujadidi, Yama F, Nana, Anusha, Padayachee, Sherman D, Phillips, Daniel J, Pittella, Ana, Plested, Emma, Pollock, Katrina M, Ramasamy, Maheshi N, Ritchie, Adam J, Robinson, Hannah, Schwarzbold, Alexandre V, Smith, Andrew, Song, Rinn, Snape, Matthew D, Sprinz, Eduardo, Sutherland, Rebecca K, Thomson, Emma C, Török, M Estée, Toshner, Mark, Turner, David PJ, Vekemans, Johan, Villafana, Tonya L, White, Thomas, Williams, Christopher J, Douglas, Alexander D, Hill, Adrian VS, Lambe, Teresa, Gilbert, Sarah C, Pollard, Andrew J, and Oxford COVID Vaccine Trial Group
- Abstract
Background\ud The ChAdOx1 nCoV-19 (AZD1222) vaccine has been approved for emergency use by the UK regulatory authority, Medicines and Healthcare products Regulatory Agency, with a regimen of two standard doses given with an interval of 4-12 weeks. The planned roll-out in the UK will involve vaccinating people in high-risk categories with their first dose immediately, and delivering the second dose 12 weeks later. Here, we provide both a further prespecified pooled analysis of trials of ChAdOx1 nCoV-19 and exploratory analyses of the impact on immunogenicity and efficacy of extending the interval between priming and booster doses. In addition, we show the immunogenicity and protection afforded by the first dose, before a booster dose has been offered.MethodsWe present data from three single-blind randomised controlled trials-one phase 1/2 study in the UK (COV001), one phase 2/3 study in the UK (COV002), and a phase 3 study in Brazil (COV003)-and one double-blind phase 1/2 study in South Africa (COV005). As previously described, individuals 18 years and older were randomly assigned 1:1 to receive two standard doses of ChAdOx1 nCoV-19 (5 × 1010 viral particles) or a control vaccine or saline placebo. In the UK trial, a subset of participants received a lower dose (2·2 × 1010 viral particles) of the ChAdOx1 nCoV-19 for the first dose. The primary outcome was virologically confirmed symptomatic COVID-19 disease, defined as a nucleic acid amplification test (NAAT)-positive swab combined with at least one qualifying symptom (fever ≥37·8°C, cough, shortness of breath, or anosmia or ageusia) more than 14 days after the second dose. Secondary efficacy analyses included cases occuring at least 22 days after the first dose. Antibody responses measured by immunoassay and by pseudovirus neutralisation were exploratory outcomes. All cases of COVID-19 with a NAAT-positive swab were adjudicated for inclusion in the analysis by a masked independent endpoint review committee. The primary analysis included all participants who were SARS-CoV-2 N protein seronegative at baseline, had had at least 14 days of follow-up after the second dose, and had no evidence of previous SARS-CoV-2 infection from NAAT swabs. Safety was assessed in all participants who received at least one dose. The four trials are registered at ISRCTN89951424 (COV003) and ClinicalTrials.gov, NCT04324606 (COV001), NCT04400838 (COV002), and NCT04444674 (COV005).FindingsBetween April 23 and Dec 6, 2020, 24 422 participants were recruited and vaccinated across the four studies, of whom 17 178 were included in the primary analysis (8597 receiving ChAdOx1 nCoV-19 and 8581 receiving control vaccine). The data cutoff for these analyses was Dec 7, 2020. 332 NAAT-positive infections met the primary endpoint of symptomatic infection more than 14 days after the second dose. Overall vaccine efficacy more than 14 days after the second dose was 66·7% (95% CI 57·4-74·0), with 84 (1·0%) cases in the 8597 participants in the ChAdOx1 nCoV-19 group and 248 (2·9%) in the 8581 participants in the control group. There were no hospital admissions for COVID-19 in the ChAdOx1 nCoV-19 group after the initial 21-day exclusion period, and 15 in the control group. 108 (0·9%) of 12 282 participants in the ChAdOx1 nCoV-19 group and 127 (1·1%) of 11 962 participants in the control group had serious adverse events. There were seven deaths considered unrelated to vaccination (two in the ChAdOx1 nCov-19 group and five in the control group), including one COVID-19-related death in one participant in the control group. Exploratory analyses showed that vaccine efficacy after a single standard dose of vaccine from day 22 to day 90 after vaccination was 76·0% (59·3-85·9). Our modelling analysis indicated that protection did not wane during this initial 3-month period. Similarly, antibody levels were maintained during this period with minimal waning by day 90 (geometric mean ratio [GMR] 0·66 [95% CI 0·59-0·74]). In the participants who received two standard doses, after the second dose, efficacy was higher in those with a longer prime-boost interval (vaccine efficacy 81·3% [95% CI 60·3-91·2] at ≥12 weeks) than in those with a short interval (vaccine efficacy 55·1% [33·0-69·9] at InterpretationThe results of this primary analysis of two doses of ChAdOx1 nCoV-19 were consistent with those seen in the interim analysis of the trials and confirm that the vaccine is efficacious, with results varying by dose interval in exploratory analyses. A 3-month dose interval might have advantages over a programme with a short dose interval for roll-out of a pandemic vaccine to protect the largest number of individuals in the population as early as possible when supplies are scarce, while also improving protection after receiving a second dose.FundingUK Research and Innovation, National Institutes of Health Research (NIHR), The Coalition for Epidemic Preparedness Innovations, the Bill & Melinda Gates Foundation, the Lemann Foundation, Rede D'Or, the Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca.
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- 2021
38. Efficacy of a low-dose candidate malaria vaccine, R21 in adjuvant Matrix-M, with seasonal administration to children in Burkina Faso: a randomised controlled trial
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Datoo, Mehreen S, primary, Natama, Magloire H, additional, Somé, Athanase, additional, Traoré, Ousmane, additional, Rouamba, Toussaint, additional, Bellamy, Duncan, additional, Yameogo, Prisca, additional, Valia, Daniel, additional, Tegneri, Moubarak, additional, Ouedraogo, Florence, additional, Soma, Rachidatou, additional, Sawadogo, Seydou, additional, Sorgho, Faizatou, additional, Derra, Karim, additional, Rouamba, Eli, additional, Orindi, Benedict, additional, Ramos Lopez, Fernando, additional, Flaxman, Amy, additional, Cappuccini, Federica, additional, Kailath, Reshma, additional, Elias, Sean, additional, Mukhopadhyay, Ekta, additional, Noe, Andres, additional, Cairns, Matthew, additional, Lawrie, Alison, additional, Roberts, Rachel, additional, Valéa, Innocent, additional, Sorgho, Hermann, additional, Williams, Nicola, additional, Glenn, Gregory, additional, Fries, Louis, additional, Reimer, Jenny, additional, Ewer, Katie J, additional, Shaligram, Umesh, additional, Hill, Adrian V S, additional, and Tinto, Halidou, additional
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- 2021
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39. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK
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Voysey, Merryn, Clemens, Sue Ann Costa, Madhi, Shabir A., Weckx, Lily Y., Folegatti, Pedro M., Aley, Parvinder K., Angus, Brian, Baillie, Vicky L., Barnabas, Shaun L., Bhorat, Qasim E., Bibi, Sagida, Briner, Carmen, Cicconi, Paola, Collins, Andrea M., Colin-Jones, Rachel, Cutland, Clare L., Darton, Thomas C., Dheda, Keertan, Duncan, Christopher J. A., Emary, Katherine R. W., Ewer, Katie J., Fairlie, Lee, Faust, Saul N., Feng, Shuo, Ferreira, Daniela M., Finn, Adam, Goodman, Anna L., Green, Catherine M., Green, Christopher A., Heath, Paul T., Hill, Catherine, Hill, Helen, Hirsch, Ian, Hodgson, Susanne H. C., Izu, Alane, Jackson, Susan, Jenkin, Daniel, Joe, Carina C. D., Kerridge, Simon, Koen, Anthonet, Kwatra, Gaurav, Lazarus, Rajeka, Lawrie, Alison M., Lelliott, Alice, Libri, Vincenzo, Lillie, Patrick J., Mallory, Raburn, Mendes, Ana V. A., Milan, Eveline P., Minassian, Angela M., McGregor, Alastair, Morrison, Hazel, Mujadidi, Yama F., Nana, Anusha, O'Reilly, Peter J., Padayachee, Sherman D., Pittella, Ana, Plested, Emma, Pollock, Katrina M., Ramasamy, Maheshi N., Rhead, Sarah, Schwarzbold, Alexandre V., Singh, Nisha, Smith, Andrew, Song, Rinn, Snape, Matthew D., Sprinz, Eduardo, Sutherland, Rebecca K., Tarrant, Richard, Thomson, Emma C., Török, Mark and Turner, Sorio, Guilherme L., Sorley, Kim, Sosa-Rodriguez, Tiffany, Souza, Cinthia M.C.D.L., Souza, Bruno S.D.F., Souza, Alessandra R., Spencer, Alexandra J., Spina, Fernanda, Spoors, Louise, Stafford, Lizzie, Stamford, Imogen, Starinskij, Igor, Stein, Ricardo, Steven, Jill, Stockdale, Lisa, Stockwell, Lisa V., Strickland, Louise H., Stuart, Arabella C., Sturdy, Ann, Sutton, Natalina, Szigeti, Anna, Tahiri-Alaoui, Abdessamad, Tanner, Rachel, Taoushanis, Carol, Tarr, Alexander W., Taylor, Keja, Taylor, Ursula, Taylor, Iona Jennifer, Taylor, Justin, te Water Naude, Rebecca, Themistocleous, Yrene, Themistocleous, Andreas, Thomas, Merin, Thomas, Kelly, Thomas, Tonia M., Thombrayil, Asha, Thompson, Fawziyah, Thompson, Amber, Thompson, Kevin, Thompson, Ameeka, Thomson, Julia, Thornton-Jones, Viv, Tighe, Patrick J., Tinoco, Lygia Accioly, Tiongson, Gerlynn, Tladinyane, Bonolo, Tomasicchio, Michele, Tomic, Adriana, Tonks, Susan, Tran, Nguyen, Tree, Julia, Trillana, Gerry, Trinham, Charlotte, Trivett, Rose, Truby, Adam, Tsheko, Betty Lebogang, Turabi, Aadil, Turner, Richard, Turner, Cheryl, Ulaszewska, Marta, Underwood, Benjamin R., Varughese, Rachel, Verbart, Dennis, Verheul, Marije, Vichos, Iason, Vieira, Taiane, Waddington, Claire S., Walker, Laura, Wallis, Erica, Wand, Matthew, Warbick, Deborah, Wardell, Theresa, Warimwe, George, Warren, Sarah C., Watkins, Bridget, Watson, Ekaterina, Webb, Stewart, Webb-Bridges, Alice, Webster, Angela, Welch, Jessica, Wells, Jeanette, West, Alison, White, Caroline, White, Rachel, Williams, Paul, Williams, Rachel L., Winslow, Rebecca, Woodyer, Mark, Worth, Andrew T., Wright, Danny, Wroblewska, Marzena, Yao, Andy, Zimmer, Rafael, Zizi, Dalila, and Zuidewind, Peter
- Abstract
Background: \ud A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials.\ud \ud Methods: \ud This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674.\ud \ud Findings: \ud Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0–75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4–97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8–80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3–4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation.\ud \ud Interpretation: \ud ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials.\ud \ud Funding: \ud UK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, Bill & Melinda Gates Foundation, Lemann Foundation, Rede D’Or, Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca.
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- 2021
40. T cell and antibody responses induced by a single dose of ChAdOx1 nCoV-19 (AZD1222) vaccine in a phase 1/2 clinical trial
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Ewer, Katie J., Barrett, Jordan R., Belij-Rammerstorfer, Sandra, Sharpe, Hannah, Makinson, Rebecca, Morter, Richard, Flaxman, Amy, Wright, Daniel, Bellamy, Duncan, Bittaye, Mustapha, Dold, Christina, Provine, Nicholas M., Aboagye, Jeremy, Fowler, Jamie, Silk, Sarah E., Alderson, Jennifer, Aley, Parvinder K., Angus, Brian, Berrie, Eleanor, Bibi, Sagida, Cicconi, Paola, Clutterbuck, Elizabeth A., Chelysheva, Irina, Folegatti, Pedro M., Fuskova, Michelle, Green, Catherine M., Jenkin, Daniel, Kerridge, Simon, Lawrie, Alison, Minassian, Angela M., Moore, Maria, Mujadidi, Yama, Plested, Emma, Poulton, Ian, Ramasamy, Maheshi N., Robinson, Hannah, Song, Rinn, Snape, Matthew D., Tarrant, Richard, Voysey, Merryn, Watson, Marion E. E., Douglas, Alexander D., Hill, Adrian V. S., Gilbert, Sarah C., Pollard, Andrew J., Lambe, Teresa, Ali, Aabidah, Allen, Elizabeth, Baker, Megan, Barnes, Eleanor, Borthwick, Nicola, Boyd, Amy, Brown-O’Sullivan, Charlie, Burgoyne, Joshua, Byard, Nicholas, Puig, Ingrid Cabrera, Cappuccini, Federica, Cho, Jee-Sun, Clark, Elizabeth, Crocker, Wendy E. M., Datoo, Mehreen S., Davies, Hannah, Donnellan, Francesca R., Dunachie, Susanna Jane, Edwards, Nick J., Elias, Sean C., Furze, Julie, Gilbride, Ciaran, Gorini, Giacomo, Gupta, Gaurav, Harris, Stephanie A., Hodgson, Susanne H. C., Hou, Mimi M., Jackson, Susan, Jones, Kathryn, Kailath, Reshma, King, Lloyd, Larkworthy, Colin W., Li, Yuanyuan, Lias, Amelia M., Linder, Aline, Lipworth, Samuel, Ramon, Raquel Lopez, Madhavan, Meera, Marlow, Emma, Marshall, Julia L., Mentzer, Alexander J., Morrison, Hazel, Moya, Nathifa, Mukhopadhyay, Ekta, Noé, Andrés, Nugent, Fay L., Pipini, Dimitra, Pulido-Gomez, David, Lopez, Fernando Ramos, Ritchie, Adam John, Rudiansyah, Indra, Salvador, Stephannie, Sanders, Helen, Satti, Iman, Shea, Adam, Silk, Sarah, Spencer, Alexandra J., Tanner, Rachel, Taylor, Iona Jennifer, Themistocleous, Yrene, Thomas, Merin, Tran, Nguyen, Truby, Adam, Turner, Cheryl, Turner, Nicola, Ulaszewska, Marta, Worth, Andrew T., Kingham-Page, Lucy, Alvarez, Marco Polo Peralta, Anslow, Rachel, Bates, Louise, Beadon, Kirsten, Beckley, Rebecca, Beveridge, Amy, Bijker, Else Margreet, Blackwell, Luke, Burbage, Jamie, Camara, Susana, Carr, Melanie, Colin-Jones, Rachel, Cooper, Rachel, Cunningham, Christina J., Demissie, Tesfaye, Maso, Claudio Di, Douglas, Naomi, Drake-Brockman, Rachael, Drury, Ruth Elizabeth, Emary, Katherine R. W., Felle, Sally, Feng, Shuo, Silva, Carla Ferreira Da, Ford, Karen J., Francis, Emma, Gracie, Lara, Hamlyn, Joseph, Hanumunthadu, Brama, Harrison, Daisy, Hart, Thomas C., Hawkins, Sophia, Hill, Jennifer, Howe, Elizabeth, Howell, Nicola, Jones, Elizabeth, Keen, Jade, Kelly, Sarah, Kerr, David, Khan, Liaquat, Kinch, Jasmin, Koleva, Stanislava, Lees, Emily A., Lelliott, Alice, Liu, Xinxue, Marchevsky, Natalie G., Marinou, Spyridoula, McEwan, Joanne, Morey, Ella, Morshead, Gertraud, Muller, Jilly, Munro, Claire, Murphy, Sarah, Mweu, Philomena, Nuthall, Elizabeth, O’Brien, Katie, O’Connor, Daniel, O’Reilly, Peter John, Oguti, Blanché, Osborne, Piper, Owino, Nelly, Parker, Kaye, Pfafferott, Katja, Phillips, Daniel, Provstgaard-Morys, Samuel, Ratcliffe, Helen, Rawlinson, Thomas, Rhead, Sarah, Roberts, Hannah, Sanders, Katherine, Silva-Reyes, Laura, Rollier, Christine S., Smith, Catherine C., Smith, David J., Stockdale, Lisa, Szigeti, Anna, Thomas, Tonia M., Thompson, Amber, Tomic, Adriana, Tonks, Susan, Varughese, Rachel, Verheul, Marije K., Vichos, Iason, Walker, Laura, White, Caroline, White, Rachel, Yao, Xin Li, Conlon, Christopher P., Frater, John, Cifuentes, Liliana, Baleanu, Ioana, Bolam, Emma, Boland, Elena, Brenner, Tanja, Damratoski, Brad E., Datta, Chandra, Muhanna, Omar El, Fisher, Richard, Galian-Rubio, Pablo, Hodges, Gina, Jackson, Frederic, Liu, Shuchang, Loew, Lisa, Morgans, Roisin, Morris, Susan Jane, Olchawski, Vicki, Oliveria, Catarina, Parracho, Helena, Pabon, Emilia Reyes, Tahiri-Alaoui, Abdessamad, Taylor, Keja, Williams, Paul, Zizi, Dalila, Arbe-Barnes, Edward H., Baker, Philip, Batten, Alexander, Downing, Charlotte, Drake, Jonathan, English, Marcus Rex, Henry, John Aaron, Iveson, Poppy, Killen, Annabel, King, Thomas B., Larwood, Jessica P. J., Mallett, Garry, Mansatta, Kushal, Mirtorabi, Neginsadat, Patrick-Smith, Maia, Perring, James, Radia, Kajal, Roche, Sophie, Schofield, Ella, Naude, Rebecca te Water, Towner, James, Baker, Natalie, Bewley, Kevin R., Brunt, Emily, Buttigieg, Karen R., Carroll, Miles W., Charlton, Sue, Coombes, Naomi S., Elmore, Michael J., Godwin, Kerry, Hallis, Bassam, Knott, Daniel, McInroy, Lorna, Shaik, Imam, Thomas, Kelly, Tree, Julia A., Blundell, Caitlin L., Cao, Michelangelo, Kelly, Dearbhla, Schmid, Annina, Skelly, Donal T., Themistocleous, Andreas, Dong, Tao, Field, Samantha, Hamilton, Elizabeth, Kelly, Elizabeth, Klenerman, Paul, Knight, Julian C., Lie, Yolanda, Petropoulos, Christos, Sedik, Cynthia, Wrin, Terri, Meddaugh, Gretchen, Peng, Yanchun, Screaton, Gavin, and Stafford, Elizabeth
- Subjects
0301 basic medicine ,biology ,business.industry ,T cell ,Immunogenicity ,General Medicine ,Vaccine efficacy ,General Biochemistry, Genetics and Molecular Biology ,Vaccination ,03 medical and health sciences ,030104 developmental biology ,0302 clinical medicine ,medicine.anatomical_structure ,Immune system ,Immunity ,030220 oncology & carcinogenesis ,Immunology ,biology.protein ,medicine ,Cytotoxic T cell ,Antibody ,business - Abstract
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of Coronavirus Disease 2019 (COVID-19), has caused a global pandemic, and safe, effective vaccines are urgently needed1. Strong, Th1-skewed T cell responses can drive protective humoral and cell-mediated immune responses2 and might reduce the potential for disease enhancement3. Cytotoxic T cells clear virus-infected host cells and contribute to control of infection4. Studies of patients infected with SARS-CoV-2 have suggested a protective role for both humoral and cell-mediated immune responses in recovery from COVID-19 (refs. 5,6). ChAdOx1 nCoV-19 (AZD1222) is a candidate SARS-CoV-2 vaccine comprising a replication-deficient simian adenovirus expressing full-length SARS-CoV-2 spike protein. We recently reported preliminary safety and immunogenicity data from a phase 1/2 trial of the ChAdOx1 nCoV-19 vaccine (NCT04400838)7 given as either a one- or two-dose regimen. The vaccine was tolerated, with induction of neutralizing antibodies and antigen-specific T cells against the SARS-CoV-2 spike protein. Here we describe, in detail, exploratory analyses of the immune responses in adults, aged 18–55 years, up to 8 weeks after vaccination with a single dose of ChAdOx1 nCoV-19 in this trial, demonstrating an induction of a Th1-biased response characterized by interferon-γ and tumor necrosis factor-α cytokine secretion by CD4+ T cells and antibody production predominantly of IgG1 and IgG3 subclasses. CD8+ T cells, of monofunctional, polyfunctional and cytotoxic phenotypes, were also induced. Taken together, these results suggest a favorable immune profile induced by ChAdOx1 nCoV-19 vaccine, supporting the progression of this vaccine candidate to ongoing phase 2/3 trials to assess vaccine efficacy. A single dose of the ChAdOx1 nCoV-19 vaccine elicits antibodies and cytokine-producing T cells that might help control or prevent SARS-CoV-2 infection.
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- 2020
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41. Analysis of human B-cell responses following ChAd63-MVA MSP1 and AMA1 immunization and controlled malaria infection
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Elias, Sean C., Choudhary, Prateek, de Cassan, Simone C., Biswas, Sumi, Collins, Katharine A., Halstead, Fenella D., Bliss, Carly M., Ewer, Katie J., Hodgson, Susanne H., Duncan, Christopher J. A., Hill, Adrian V. S., and Draper, Simon J.
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- 2014
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42. Safety and Immunogenicity of Adenovirus and Poxvirus Vectored Vaccines against a Mycobacterium Avium Complex Subspecies
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Folegatti, Pedro M., primary, Flaxman, Amy, additional, Jenkin, Daniel, additional, Makinson, Rebecca, additional, Kingham-Page, Lucy, additional, Bellamy, Duncan, additional, Ramos Lopez, Fernando, additional, Sheridan, Jonathan, additional, Poulton, Ian, additional, Aboagye, Jeremy, additional, Tran, Nguyen, additional, Mitton, Celia, additional, Roberts, Rachel, additional, Lawrie, Alison M., additional, Hill, Adrian V. S., additional, Ewer, Katie J., additional, and Gilbert, Sarah, additional
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- 2021
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43. Qualified Biolayer Interferometry Avidity Measurements Distinguish the Heterogeneity of Antibody Interactions with Plasmodium falciparum Circumsporozoite Protein Antigens
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Dennison, S. Moses, Reichartz, Matthew, Seaton, Kelly E., Dutta, Sheetij, Wille-Reece, Ulrike, Hill, Adrian V. S., Ewer, Katie J., Rountree, Wes, Sarzotti-Kelsoe, Marcella, Ozaki, Daniel A., Alam, S. Munir, and Tomaras, Georgia D.
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Interferometry ,Novel Immunological Methods ,parasitic diseases ,Malaria Vaccines ,Plasmodium falciparum ,Antibody Affinity ,Antibodies, Protozoan ,Humans ,chemical and pharmacologic phenomena ,Antigens, Protozoan ,Malaria, Falciparum - Abstract
Ab avidity is a measure of the overall strength of Ab–Ag interactions and hence is important for understanding the functional efficiency of Abs. In vaccine evaluations, Ab avidity measurements can provide insights into immune correlates of protection and generate hypotheses regarding mechanisms of protection to improve vaccine design to achieve higher levels of efficacy. The commonly used Ab avidity assays require the use of chaotropic reagents to measure avidity index. In this study, using real-time detection of Ab–Ag binding by biolayer interferometry (BLI) technique, we have developed a qualified assay for measuring avidity of vaccine-induced Abs specific for Plasmodium falciparum circumsporozoite protein (CSP) Ags. Human mAb derived from plasmablasts of recipients of RTS,S/AS01 (RTS,S), the most advanced malaria vaccine candidate, were used in the assay development to measure Ag-specific binding responses and rate constants of association and dissociation. The optimized BLI binding assay demonstrated 1) good precision (percentage of coefficient of variation
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- 2018
44. High Efficacy of a Low Dose Candidate Malaria Vaccine, R21 in 1 Adjuvant Matrix-M™, with Seasonal Administration to Children in Burkina Faso
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Datoo, Mehreen S., primary, Magloire Natama, Hamtandi, additional, Somé, Athanase, additional, Traoré, Ousmane, additional, Rouamba, Toussaint, additional, Bellamy, Duncan, additional, Yameogo, Prisca, additional, Valia, Daniel, additional, Tegneri, Moubarak, additional, Ouedraogo, Florence, additional, Soma, Rachidatou, additional, Sawadogo, Seydou, additional, Sorgho, Faizatou, additional, Derra, Karim, additional, Rouamba, Eli, additional, Orindi, Benedict, additional, Ramos-Lopez, Fernando, additional, Flaxman, Amy, additional, Cappuccini, Federica, additional, Kailath, Reshma, additional, Elias, Sean C., additional, Mukhopadhyay, Ekta, additional, Noe, Andres, additional, Cairns, Matthew, additional, Lawrie, Alison, additional, Roberts, Rachel, additional, Valéa, Innocent, additional, Sorgho, Hermann, additional, Williams, Nicola, additional, Glenn, Gregory, additional, Fries, Louis, additional, Reimer, Jenny, additional, Ewer, Katie J., additional, Shaligram, Umesh, additional, Hill, Adrian V. S., additional, and Tinto, Halidou, additional
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- 2021
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45. Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial
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Ramasamy, Maheshi N, primary, Minassian, Angela M, additional, Ewer, Katie J, additional, Flaxman, Amy L, additional, Folegatti, Pedro M, additional, Owens, Daniel R, additional, Voysey, Merryn, additional, Aley, Parvinder K, additional, Angus, Brian, additional, Babbage, Gavin, additional, Belij-Rammerstorfer, Sandra, additional, Berry, Lisa, additional, Bibi, Sagida, additional, Bittaye, Mustapha, additional, Cathie, Katrina, additional, Chappell, Harry, additional, Charlton, Sue, additional, Cicconi, Paola, additional, Clutterbuck, Elizabeth A, additional, Colin-Jones, Rachel, additional, Dold, Christina, additional, Emary, Katherine R W, additional, Fedosyuk, Sofiya, additional, Fuskova, Michelle, additional, Gbesemete, Diane, additional, Green, Catherine, additional, Hallis, Bassam, additional, Hou, Mimi M, additional, Jenkin, Daniel, additional, Joe, Carina C D, additional, Kelly, Elizabeth J, additional, Kerridge, Simon, additional, Lawrie, Alison M, additional, Lelliott, Alice, additional, Lwin, May N, additional, Makinson, Rebecca, additional, Marchevsky, Natalie G, additional, Mujadidi, Yama, additional, Munro, Alasdair P S, additional, Pacurar, Mihaela, additional, Plested, Emma, additional, Rand, Jade, additional, Rawlinson, Thomas, additional, Rhead, Sarah, additional, Robinson, Hannah, additional, Ritchie, Adam J, additional, Ross-Russell, Amy L, additional, Saich, Stephen, additional, Singh, Nisha, additional, Smith, Catherine C, additional, Snape, Matthew D, additional, Song, Rinn, additional, Tarrant, Richard, additional, Themistocleous, Yrene, additional, Thomas, Kelly M, additional, Villafana, Tonya L, additional, Warren, Sarah C, additional, Watson, Marion E E, additional, Douglas, Alexander D, additional, Hill, Adrian V S, additional, Lambe, Teresa, additional, Gilbert, Sarah C, additional, Faust, Saul N, additional, Pollard, Andrew J, additional, Aboagye, Jeremy, additional, Adams, Kelly, additional, Ali, Aabidah, additional, Allen, Elizabeth R., additional, Allen, Lauren, additional, Allison, Jennifer L., additional, Andritsou, Foteini, additional, Anslow, Rachel, additional, Arbe-Barnes, Edward H., additional, Baker, Megan, additional, Baker, Natalie, additional, Baker, Philip, additional, Baleanu, Ioana, additional, Barker, Debbie, additional, Barnes, Eleanor, additional, Barrett, Jordan R., additional, Barrett, Kelly, additional, Bates, Louise, additional, Batten, Alexander, additional, Beadon, Kirsten, additional, Beckley, Rebecca, additional, Bellamy, Duncan, additional, Berg, Adam, additional, Bermejo, Laura, additional, Berrie, Eleanor, additional, Beveridge, Amy, additional, Bewley, Kevin, additional, Bijker, Else M., additional, Birch, Geeta, additional, Blackwell, Luke, additional, Bletchly, Heather, additional, Blundell, Caitlin L., additional, Blundell, Susannah R., additional, Bolam, Emma, additional, Boland, Elena, additional, Bormans, Daan, additional, Borthwick, Nicola, additional, Boukas, Konstantinos, additional, Bower, Thomas, additional, Bowring, Francesca, additional, Boyd, Amy, additional, Brenner, Tanja, additional, Brown, Phillip, additional, Brown-O'Sullivan, Charlie, additional, Bruce, Scott, additional, Brunt, Emily, additional, Burbage, Jamie, additional, Burgoyne, Joshua, additional, Buttigieg, Karen R., additional, Byard, Nicholas, additional, Cabera Puig, Ingrid, additional, Camara, Susana, additional, Cao, Michelangelo, additional, Cappuccini, Federica, additional, Carr, Melanie, additional, Carroll, Miles W., additional, Cashen, Paul, additional, Cavey, Ana, additional, Chadwick, Jim, additional, Challis, Ruth, additional, Chapman, David, additional, Charles, David, additional, Chelysheva, Irina, additional, Cho, Jee-Sun, additional, Cifuentes, Liliana, additional, Clark, Elizabeth, additional, Collins, Sarah, additional, Conlon, Christopher P., additional, Coombes, Naomi S., additional, Cooper, Rachel, additional, Cooper, Cushla, additional, Crocker, Wendy E.M., additional, Crosbie, Sarah, additional, Cullen, Dan, additional, Cunningham, Christina, additional, Cuthbertson, Fiona, additional, Datoo, Brad E., additional, Dando, Lynne, additional, Datoo, Mehreen S., additional, Datta, Chandrabali, additional, Davies, Hannah, additional, Davies, Sarah, additional, Davis, Elizabeth J., additional, Davis, Judith, additional, Dearlove, David, additional, Demissie, Tesfaye, additional, Di Marco, Stefania, additional, Di Maso, Claudio, additional, DiTirro, Danielle, additional, Docksey, Claire, additional, Dong, Tao, additional, Donnellan, Francesca R., additional, Douglas, Naomi, additional, Downing, Charlotte, additional, Drake, Jonathan, additional, Drake-Brockman, Rachael, additional, Drury, Ruth E., additional, Dunachie, Susanna J., additional, Edwards, Christopher J., additional, Edwards, Nick J., additional, El Muhanna, Omar, additional, Elias, Sean C., additional, Elliott, Ryan S., additional, Elmore, Michael J., additional, English, Marcus Rex, additional, Felle, Sally, additional, Feng, Shuo, additional, Ferreira Da Silva, Carla, additional, Field, Samantha, additional, Fisher, Richard, additional, Fixmer, Carine, additional, Ford, Karen J., additional, Fowler, Jamie, additional, Francis, Emma, additional, Frater, John, additional, Furze, Julie, additional, Galian-Rubio, Pablo, additional, Galloway, Celine, additional, Garlant, Harriet, additional, Gavrila, Madita, additional, Gibbons, Felicity, additional, Gibbons, Karyna, additional, Gilbride, Ciaran, additional, Gill, Hardeep, additional, Godwin, Kerry, additional, Gordon-Quayle, Katherine, additional, Gorini, Giacomo, additional, Goulston, Lyndsey, additional, Grabau, Caroline, additional, Gracie, Lara, additional, Graham, Nichola, additional, Greenwood, Nicola, additional, Griffiths, Oliver, additional, Gupta, Gaurav, additional, Hamilton, Elizabeth, additional, Hanumunthadu, Brama, additional, Harris, Stephanie A., additional, Harris, Tara, additional, Harrison, Daisy, additional, Hart, Thomas C., additional, Hartnell, Birgit, additional, Haskell, Louise, additional, Hawkins, Sophia, additional, Henry, John Aaron, additional, Hermosin Herrera, Macarena, additional, Hill, David, additional, Hill, Jennifer, additional, Hodges, Gina, additional, Hodgson, Susanne H.C., additional, Horton, Katie L., additional, Howe, Elizabeth, additional, Howell, Nicola, additional, Howes, Jessica, additional, Huang, Ben, additional, Humphreys, Jonathan, additional, Humphries, Holly E., additional, Iveson, Poppy, additional, Jackson, Frederic, additional, Jackson, Susan, additional, Jauregui, Sam, additional, Jeffers, Helen, additional, Jones, Bryony, additional, Jones, Christine E., additional, Jones, Elizabeth, additional, Jones, Kathryn, additional, Joshi, Amar, additional, Kailath, Reshma, additional, Keen, Jade, additional, Kelly, Dearbhla M., additional, Kelly, Sarah, additional, Kelly, Debbie, additional, Kerr, David, additional, Khan, Liaquat, additional, Khozoee, Baktash, additional, Killen, Annabel, additional, Kinch, Jasmin, additional, King, Lloyd D.W., additional, King, Thomas B., additional, Kingham, Lucy, additional, Klenerman, Paul, additional, Knight, Julian C., additional, Knott, Daniel, additional, Koleva, Stanislava, additional, Lang, Gail, additional, Larkworthy, Colin W., additional, Larwood, Jessica P.J., additional, Law, Rebecca, additional, Lee, Arlene, additional, Lee, Kim Y.N., additional, Lees, Emily A., additional, Leung, Stephanie, additional, Li, Yuanyuan, additional, Lias, Amelia M., additional, Linder, Aline, additional, Lipworth, Samuel, additional, Liu, Shuchang, additional, Liu, Xinxue, additional, Lloyd, Stephanie, additional, Loew, Lisa, additional, Lopez Ramon, Raquel, additional, Madhavan, Meera, additional, Mainwaring, David O., additional, Mallett, Garry, additional, Mansatta, Kushal, additional, Marinou, Spyridoula, additional, Marius, Phedra, additional, Marlow, Emma, additional, Marriott, Paula, additional, Marshall, Julia L., additional, Martin, Jane, additional, Masters, Shauna, additional, McEwan, Joanne, additional, McGlashan, Joanna L., additional, McInroy, Lorna, additional, McRobert, Nicky, additional, Megson, Clare, additional, Mentzer, Alexander J., additional, Mirtorabi, Neginsadat, additional, Mitton, Celia, additional, Moore, Maria, additional, Moran, Marni, additional, Morey, Ella, additional, Morgans, Róisín, additional, Morris, Susan J., additional, Morrison, Hazel Morrison, additional, Morshead, Gertraud, additional, Morter, Richard, additional, Moya, Nathifa A., additional, Mukhopadhyay, Ekta, additional, Muller, Jilly, additional, Munro, Claire, additional, Murphy, Sarah, additional, Mweu, Philomena, additional, Noé, Andrés, additional, Nugent, Fay L., additional, O'Brien, Katie, additional, O'Connor, Daniel, additional, Oguti, Blanché, additional, Olchawski, Victoria, additional, Oliveira, Catarina, additional, O'Reilly, Peter John, additional, Osborne, Piper, additional, Owen, Lydia, additional, Owino, Nelly, additional, Papageorgiou, Panagiotis, additional, Parracho, Helena, additional, Parsons, Karen, additional, Patel, Bhumika, additional, Patrick-Smith, Maia, additional, Peng, Yanchun, additional, Penn, Elizabeth J., additional, Peralta-Alvarez, Marco Polo, additional, Perring, James, additional, Petropoulos, Christos, additional, Phillips, Daniel J., additional, Pipini, Dimitra, additional, Pollard, Samuel, additional, Poulton, Ian, additional, Pratt, Danny, additional, Presland, Laura, additional, Proud, Pamela C., additional, Provstgaard-Morys, Samuel, additional, Pueschel, Sophie, additional, Pulido, David, additional, Rabara, Ria, additional, Radia, Kajal, additional, Rajapaska, Durga, additional, Ramos Lopez, Fernando, additional, Ratcliffe, Helen, additional, Rayhan, Sara, additional, Rees, Byron, additional, Reyes Pabon, Emilia, additional, Roberts, Hannah, additional, Robertson, Isla, additional, Roche, Sophie, additional, Rollier, Christine S., additional, Romani, Rossana, additional, Rose, Zoe, additional, Rudiansyah, Indra, additional, Sabheha, Sabeha, additional, Salvador, Stephannie, additional, Sanders, Helen, additional, Sanders, Katherine, additional, Satti, Iman, additional, Sayce, Chloe, additional, Schmid, Annina B., additional, Schofield, Ella, additional, Screaton, Gavin, additional, Sedik, Cynthia, additional, Seddiqi, Samiullah, additional, Segireddy, Rameswara R., additional, Selby, Beatrice, additional, Shaik, Imam, additional, Sharpe, Hannah R., additional, Shaw, Robert, additional, Shea, Adam, additional, Silk, Sarah, additional, Silva-Reyes, Laura, additional, Skelly, Donal T., additional, Smith, David J., additional, Smith, Daniel C., additional, Smith, Nicholas, additional, Spencer, Alexandra J., additional, Spoors, Louise, additional, Stafford, Elizabeth, additional, Stamford, Imogen, additional, Stockdale, Lisa, additional, Stockley, David, additional, Stockwell, Lisa V., additional, Stokes, Matthew, additional, Strickland, Louise H., additional, Stuart, Arabella, additional, Sulaiman, Sulaiman, additional, Summerton, Eloise, additional, Swash, Zoe, additional, Szigeti, Anna, additional, Tahiri-Alaoui, Abdessamad, additional, Tanner, Rachel, additional, Taylor, Iona, additional, Taylor, Keja, additional, Taylor, Ursula, additional, te Water Naude, Rebecca, additional, Themistocleous, Andreas, additional, Thomas, Merin, additional, Thomas, Tonia M., additional, Thompson, Amber, additional, Thompson, Kevin, additional, Thornton-Jones, Viv, additional, Tinh, Lan, additional, Tomic, Adriana, additional, Tonks, Susan, additional, Towner, James, additional, Tran, Nguyen, additional, Tree, Julian A., additional, Truby, Adam, additional, Turner, Cheryl, additional, Turner, Richard, additional, Ulaszewska, Marta, additional, Varughese, Rachel, additional, Verbart, Dennis, additional, Verheul, Marije K., additional, Vichos, Iason, additional, Walker, Laura, additional, Wand, Matthew E., additional, Watkins, Bridget, additional, Welch, Jessica, additional, West, Alison J., additional, White, Caroline, additional, White, Rachel, additional, Williams, Paul, additional, Woodyer, Mark, additional, Worth, Andrew T., additional, Wright, Daniel, additional, Wrin, Terri, additional, Yao, Xin Li, additional, Zbarcea, Diana-Andreea, additional, and Zizi, Dalila, additional
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- 2020
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46. Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial
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Folegatti, Pedro M, primary, Ewer, Katie J, additional, Aley, Parvinder K, additional, Angus, Brian, additional, Becker, Stephan, additional, Belij-Rammerstorfer, Sandra, additional, Bellamy, Duncan, additional, Bibi, Sagida, additional, Bittaye, Mustapha, additional, Clutterbuck, Elizabeth A, additional, Dold, Christina, additional, Faust, Saul N, additional, Finn, Adam, additional, Flaxman, Amy L, additional, Hallis, Bassam, additional, Heath, Paul, additional, Jenkin, Daniel, additional, Lazarus, Rajeka, additional, Makinson, Rebecca, additional, Minassian, Angela M, additional, Pollock, Katrina M, additional, Ramasamy, Maheshi, additional, Robinson, Hannah, additional, Snape, Matthew, additional, Tarrant, Richard, additional, Voysey, Merryn, additional, Green, Catherine, additional, Douglas, Alexander D, additional, Hill, Adrian V S, additional, Lambe, Teresa, additional, Gilbert, Sarah C, additional, Pollard, Andrew J, additional, Aboagye, Jeremy, additional, Adams, Kelly, additional, Ali, Aabidah, additional, Allen, Elizabeth, additional, Allison, Jennifer L., additional, Anslow, Rachel, additional, Arbe-Barnes, Edward H., additional, Babbage, Gavin, additional, Baillie, Kenneth, additional, Baker, Megan, additional, Baker, Natalie, additional, Baker, Philip, additional, Baleanu, Ioana, additional, Ballaminut, Juliana, additional, Barnes, Eleanor, additional, Barrett, Jordan, additional, Bates, Louise, additional, Batten, Alexander, additional, Beadon, Kirsten, additional, Beckley, Rebecca, additional, Berrie, Eleanor, additional, Berry, Lisa, additional, Beveridge, Amy, additional, Bewley, Kevin R., additional, Bijker, Else Margreet, additional, Bingham, Tracey, additional, Blackwell, Luke, additional, Blundell, Caitlin L., additional, Bolam, Emma, additional, Boland, Elena, additional, Borthwick, Nicola, additional, Bower, Thomas, additional, Boyd, Amy, additional, Brenner, Tanja, additional, Bright, Philip D., additional, Brown-O'Sullivan, Charlie, additional, Brunt, Emily, additional, Burbage, Jamie, additional, Burge, Sharon, additional, Buttigieg, Karen R., additional, Byard, Nicholas, additional, Cabera Puig, Ingrid, additional, Calvert, Anna, additional, Camara, Susana, additional, Cao, Michelangelo, additional, Cappuccini, Federica, additional, Carr, Melanie, additional, Carroll, Miles W., additional, Carter, Victoria, additional, Cathie, Katrina, additional, Challis, Ruth J., additional, Charlton, Sue, additional, Chelysheva, Irina, additional, Cho, Jee-Sun, additional, Cicconi, Paola, additional, Cifuentes, Liliana, additional, Clark, Helen, additional, Clark, Elizabeth, additional, Cole, Tom, additional, Colin-Jones, Rachel, additional, Conlon, Christopher P., additional, Cook, Aislinn, additional, Coombes, Naomi S., additional, Cooper, Rachel, additional, Cosgrove, Catherine A., additional, Coy, Karen, additional, Crocker, Wendy E.M., additional, Cunningham, Christina J., additional, Damratoski, Brad E., additional, Dando, Lynne, additional, Datoo, Mehreen S., additional, Davies, Hannah, additional, De Graaf, Hans, additional, Demissie, Tesfaye, additional, Di Maso, Claudio, additional, Dietrich, Isabelle, additional, Dong, Tao, additional, Donnellan, Francesca R., additional, Douglas, Naomi, additional, Downing, Charlotte, additional, Drake, Jonathan, additional, Drake-Brockman, Rachael, additional, Drury, Ruth Elizabeth, additional, Dunachie, Susanna Jane, additional, Edwards, Nick J., additional, Edwards, Frances D.L., additional, Edwards, Chris J., additional, Elias, Sean C., additional, Elmore, Michael J., additional, Emary, Katherine R.W., additional, English, Marcus Rex, additional, Fagerbrink, Susanne, additional, Felle, Sally, additional, Feng, Shuo, additional, Field, Samantha, additional, Fixmer, Carine, additional, Fletcher, Clare, additional, Ford, Karen J., additional, Fowler, Jamie, additional, Fox, Polly, additional, Francis, Emma, additional, Frater, John, additional, Furze, Julie, additional, Fuskova, Michelle, additional, Galiza, Eva, additional, Gbesemete, Diane, additional, Gilbride, Ciaran, additional, Godwin, Kerry, additional, Gorini, Giacomo, additional, Goulston, Lyndsey, additional, Grabau, Caroline, additional, Gracie, Lara, additional, Gray, Zoe, additional, Guthrie, Lucy Belle, additional, Hackett, Mark, additional, Halwe, Sandro, additional, Hamilton, Elizabeth, additional, Hamlyn, Joseph, additional, Hanumunthadu, Brama, additional, Harding, Irasha, additional, Harris, Stephanie A., additional, Harris, Andrew, additional, Harrison, Daisy, additional, Harrison, Clare, additional, Hart, Thomas C., additional, Haskell, Louise, additional, Hawkins, Sophia, additional, Head, Ian, additional, Henry, John Aaron, additional, Hill, Jennifer, additional, Hodgson, Susanne H.C., additional, Hou, Mimi M., additional, Howe, Elizabeth, additional, Howell, Nicola, additional, Hutlin, Cecilia, additional, Ikram, Sabina, additional, Isitt, Catherine, additional, Iveson, Poppy, additional, Jackson, Susan, additional, Jackson, Frederic, additional, James, Sir William, additional, Jenkins, Megan, additional, Jones, Elizabeth, additional, Jones, Kathryn, additional, Jones, Christine E., additional, Jones, Bryony, additional, Kailath, Reshma, additional, Karampatsas, Konstantinos, additional, Keen, Jade, additional, Kelly, Sarah, additional, Kelly, Dearbhla, additional, Kerr, David, additional, Kerridge, Simon, additional, Khan, Liaquat, additional, Khan, Uzma, additional, Killen, Annabel, additional, Kinch, Jasmin, additional, King, Thomas B., additional, King, Lloyd, additional, King, Jade, additional, Kingham-Page, Lucy, additional, Klenerman, Paul, additional, Knapper, Francesca, additional, Knight, Julian C., additional, Knott, Daniel, additional, Koleva, Stanislava, additional, Kupke, Alexandra, additional, Larkworthy, Colin W., additional, Larwood, Jessica P.J., additional, Laskey, Anna, additional, Lawrie, Alison M., additional, Lee, Arlene, additional, Ngan Lee, Kim Yee, additional, Lees, Emily A, additional, Legge, Helen, additional, Lelliott, Alice, additional, Lemm, Nana-Marie, additional, Lias, Amelia M., additional, Linder, Aline, additional, Lipworth, Samuel, additional, Liu, Xinxue, additional, Liu, Shuchang, additional, Lopez Ramon, Raquel, additional, Lwin, May, additional, Mabesa, Francesca, additional, Madhavan, Meera, additional, Mallett, Garry, additional, Mansatta, Kushal, additional, Marcal, Ines, additional, Marinou, Spyridoula, additional, Marlow, Emma, additional, Marshall, Julia L., additional, Martin, Jane, additional, McEwan, Joanne, additional, McInroy, Lorna, additional, Meddaugh, Gretchen, additional, Mentzer, Alexander J., additional, Mirtorabi, Neginsadat, additional, Moore, Maria, additional, Moran, Edward, additional, Morey, Ella, additional, Morgan, Victoria, additional, Morris, Susan Jane, additional, Morrison, Hazel, additional, Morshead, Gertraud, additional, Morter, Richard, additional, Mujadidi, Yama F., additional, Muller, Jilly, additional, Munera-Huertas, Tatiana, additional, Munro, Claire, additional, Munro, Alasdair, additional, Murphy, Sarah, additional, Munster, Vincent J., additional, Mweu, Philomena, additional, Noé, Andrés, additional, Nugent, Fay L., additional, Nuthall, Elizabeth, additional, O'Brien, Katie, additional, O'Connor, Daniel, additional, Oguti, Blanché, additional, Oliver, Jennifer L., additional, Oliveira, Catarina, additional, O'Reilly, Peter John, additional, Osborn, Mairead, additional, Osborne, Piper, additional, Owen, Cathy, additional, Owens, Daniel, additional, Owino, Nelly, additional, Pacurar, Mihaela, additional, Parker, Kaye, additional, Parracho, Helena, additional, Patrick-Smith, Maia, additional, Payne, Victoria, additional, Pearce, Jennifer, additional, Peng, Yanchun, additional, Peralta Alvarez, Marco Polo, additional, Perring, James, additional, Pfafferott, Katja, additional, Pipini, Dimitra, additional, Plested, Emma, additional, Pluess-Hall, Helen, additional, Pollock, Katrina, additional, Poulton, Ian, additional, Presland, Laura, additional, Provstgaard-Morys, Samuel, additional, Pulido, David, additional, Radia, Kajal, additional, Ramos Lopez, Fernando, additional, Rand, Jade, additional, Ratcliffe, Helen, additional, Rawlinson, Thomas, additional, Rhead, Sarah, additional, Riddell, Amy, additional, Ritchie, Adam John, additional, Roberts, Hannah, additional, Robson, Joanna, additional, Roche, Sophie, additional, Rohde, Cornelius, additional, Rollier, Christine S., additional, Romani, Rossana, additional, Rudiansyah, Indra, additional, Saich, Stephen, additional, Sajjad, Sara, additional, Salvador, Stephannie, additional, Sanchez Riera, Lidia, additional, Sanders, Helen, additional, Sanders, Katherine, additional, Sapaun, Shari, additional, Sayce, Chloe, additional, Schofield, Ella, additional, Screaton, Gavin, additional, Selby, Beatrice, additional, Semple, Calum, additional, Sharpe, Hannah R., additional, Shaik, Imam, additional, Shea, Adam, additional, Shelton, Holly, additional, Silk, Sarah, additional, Silva-Reyes, Laura, additional, Skelly, Donal T., additional, Smee, Heather, additional, Smith, Catherine C., additional, Smith, David J., additional, Song, Rinn, additional, Spencer, Alexandra J., additional, Stafford, Elizabeth, additional, Steele, Amy, additional, Stefanova, Elena, additional, Stockdale, Lisa, additional, Szigeti, Anna, additional, Tahiri-Alaoui, Abdessamad, additional, Tait, Moira, additional, Talbot, Helen, additional, Tanner, Rachel, additional, Taylor, Iona Jennifer, additional, Taylor, Victoria, additional, Te Water Naude, Rebecca, additional, Thakur, Nazia, additional, Themistocleous, Yrene, additional, Themistocleous, Andreas, additional, Thomas, Merin, additional, Thomas, Tonia M., additional, Thompson, Amber, additional, Thomson-Hill, Samantha, additional, Tomlins, Jennifer, additional, Tonks, Susan, additional, Towner, James, additional, Tran, Nguyen, additional, Tree, Julia A., additional, Truby, Adam, additional, Turkentine, Kate, additional, Turner, Cheryl, additional, Turner, Nicola, additional, Turner, Sally, additional, Tuthill, Toby, additional, Ulaszewska, Marta, additional, Varughese, Rachel, additional, Van Doremalen, Neeltje, additional, Veighey, Kristin, additional, Verheul, Marije K., additional, Vichos, Iason, additional, Vitale, Elia, additional, Walker, Laura, additional, Watson, Marion E.E., additional, Welham, Benjamin, additional, Wheat, Julie, additional, White, Caroline, additional, White, Rachel, additional, Worth, Andrew T., additional, Wright, Danny, additional, Wright, Suzie, additional, Yao, Xin Li, additional, and Yau, Yasmine, additional
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- 2020
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47. Reduced Ebola vaccine responses in CMV+ young adults is associated with expansion of CD57+KLRG1+ T cells
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Bowyer, Georgina, primary, Sharpe, Hannah, additional, Venkatraman, Navin, additional, Ndiaye, Pierre Birahim, additional, Wade, Djibril, additional, Brenner, Nicole, additional, Mentzer, Alex, additional, Mair, Catherine, additional, Waterboer, Tim, additional, Lambe, Teresa, additional, Dieye, Tandakha, additional, Mboup, Souleymane, additional, Hill, Adrian V.S., additional, and Ewer, Katie J., additional
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- 2020
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48. Characterization of Antigenic MHC-Class-I-Restricted T Cell Epitopes in the Glycoprotein of Ebolavirus
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Powlson, Jonathan, primary, Wright, Daniel, additional, Zeltina, Antra, additional, Giza, Mark, additional, Nielsen, Morten, additional, Rampling, Tommy, additional, Venkatrakaman, Navin, additional, Bowden, Thomas A., additional, Hill, Adrian V.S., additional, and Ewer, Katie J., additional
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- 2019
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49. Assessment of novel vaccination regimens using viral vectored liver stage malaria vaccines encoding ME-TRAP
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Bliss, Carly M., Bowyer, Georgina, Anagnostou, Nicholas A., Havelock, Tom, Snudden, Claudia M., Davies, Huw, de Cassan, Simone C., Grobbelaar, Amy, Lawrie, Alison M., Venkatraman, Navin, Poulton, Ian D., Roberts, Rachel, Mange, Pooja B., Choudhary, Prateek, Faust, Saul N., Colloca, Stefano, Gilbert, Sarah C., Nicosia, Alfredo, Hill, Adrian V. S., Ewer, Katie J., Bliss, Carly M., Bowyer, Georgina, Anagnostou, Nicholas A., Havelock, Tom, Snudden, Claudia M., Davies, Huw, De Cassan, Simone C., Grobbelaar, Amy, Lawrie, Alison M., Venkatraman, Navin, Poulton, Ian D., Roberts, Rachel, Mange, Pooja B., Choudhary, Prateek, Faust, Saul N., Colloca, Stefano, Gilbert, Sarah C., Nicosia, Alfredo, Hill, Adrian V. S., and Ewer, Katie J.
- Subjects
Adult ,Male ,Adolescent ,Genetic Vectors ,Plasmodium falciparum ,Immunization, Secondary ,Protozoan Proteins ,lcsh:Medicine ,Antibodies, Protozoan ,Antigens, Protozoan ,Vaccinia virus ,CD8-Positive T-Lymphocytes ,Article ,Epitopes ,Young Adult ,Malaria Vaccines ,Vaccinia ,Humans ,Malaria, Falciparum ,lcsh:Science ,Multidisciplinary ,lcsh:R ,Vaccination ,Middle Aged ,Liver ,Adenoviruses, Simian ,lcsh:Q ,Female - Abstract
Heterologous prime-boost vaccination with viral vectors simian adenovirus 63 (ChAd63) and Modified Vaccinia Ankara (MVA) induces potent T cell and antibody responses in humans. The 8-week regimen demonstrates significant efficacy against malaria when expressing the pre-erythrocytic malaria antigen Thrombospondin-Related Adhesion Protein fused to a multiple epitope string (ME-TRAP).We tested these vaccines in 7 new 4- and 8- week interval schedules to evaluate safety and immunogenicity of multiple ChAd63 ME-TRAP priming vaccinations (denoted A), multiple MVA ME-TRAP boosts (denoted M) and alternating vectors. All regimes exhibited acceptable reactogenicity and CD8+ T cell immunogenicity was enhanced with a 4-week interval (AM) and with incorporation of additional ChAd63 ME-TRAP vaccination at 4- or 8-weeks (AAM or A_A_M). Induction of TRAP antibodies was comparable between schedules. T cell immunity against the ChAd63 hexon did not affect T cell responses to the vaccine insert, however pre-vaccination ChAd63-specific T cells correlated with reduced TRAP antibodies. Vaccine-induced antibodies against MVA did not affect TRAP antibody induction, and correlated positively with ME-TRAP-specific T cells. This study identifies potentially more effective immunisation regimens to assess in Phase IIa trials and demonstrates a degree of flexibility with the timing of vectored vaccine administration, aiding incorporation into existing vaccination programmes.
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- 2018
50. Safety and immunogenicity of a heterologous prime-boost Ebola virus vaccine regimen in healthy adults in the United Kingdom and Senegal
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Venkatraman, Navin, Ndiaye, Birahim Pierre, Bowyer, Georgina, Wade, Djibril, Sridhar, Saranya, Wright, Daniel, Powlson, Jonathan, Ndiaye, Ibrahima, Dièye, Siry, Thompson, Craig, Bakhoum, Momar, Morter, Richard, Capone, Stefania, Del Sorbo, Mariarosaria, Jamieson, Sophie, Rampling, Tommy, Datoo, Mehreen, Roberts, Rachel, Poulton, Ian, Griffiths, Oliver, Ballou, W Ripley, Roman, François, Lewis, David J M, Lawrie, Alison, Imoukhuede, Egeruan, Gilbert, Sarah C, Dieye, Tandakha N, Ewer, Katie J, Mboup, Souleymane, and Hill, Adrian V S
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Adult ,Male ,viral vectors ,Adolescent ,viruses ,Immunization, Secondary ,Middle Aged ,ChAd3 ,Ebolavirus ,complex mixtures ,Senegal ,United Kingdom ,Major Articles and Brief Reports ,Young Adult ,vaccine ,Viruses ,Ebola ,Humans ,MVA ,EBO-Z ,Female ,Ebola Vaccines ,Immunization Schedule - Abstract
Background The 2014 West African outbreak of Ebola virus disease highlighted the urgent need to develop an effective Ebola vaccine. Methods We undertook 2 phase 1 studies assessing safety and immunogenicity of the viral vector modified vaccinia Ankara virus vectored Ebola Zaire vaccine (MVA-EBO-Z), manufactured rapidly on a new duck cell line either alone or in a heterologous prime-boost regimen with recombinant chimpanzee adenovirus type 3 vectored Ebola Zaire vaccine (ChAd3-EBO-Z) followed by MVA-EBO-Z. Adult volunteers in the United Kingdom (n = 38) and Senegal (n = 40) were vaccinated and an accelerated 1-week prime-boost regimen was assessed in Senegal. Safety was assessed by active and passive collection of local and systemic adverse events. Results The standard and accelerated heterologous prime-boost regimens were well-tolerated and elicited potent cellular and humoral immunogenicity in the United Kingdom and Senegal, but vaccine-induced antibody responses were significantly lower in Senegal. Cellular immune responses measured by flow cytometry were significantly greater in African vaccinees receiving ChAd3 and MVA vaccines in the same rather than the contralateral limb. Conclusions MVA biomanufactured on an immortalized duck cell line shows potential for very large-scale manufacturing with lower cost of goods. This first trial of MVA-EBO-Z in humans encourages further testing in phase 2 studies, with the 1-week prime-boost interval regimen appearing to be particularly suitable for outbreak control. Clinical Trials Registration NCT02451891; NCT02485912., New vaccines are needed for outbreak pathogens and novel technologies to manufacture them. We describe 2 phase 1 clinical trials demonstrating safety and immunogenicity of a novel Ebola vaccine manufactured using an improved method to reduce costs and increase yield.
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- 2018
Catalog
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