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4. Comparison of bivalent and monovalent SARS-CoV-2 variant vaccines: the phase 2 randomized open-label COVAIL trial

Author

Branche, Angela R., Rouphael, Nadine G., Diemert, David J., Falsey, Ann R., Losada, Cecilia, Baden, Lindsey R., Frey, Sharon E., Whitaker, Jennifer A., Little, Susan J., Anderson, Evan J., Walter, Emmanuel B., Novak, Richard M., Rupp, Richard, Jackson, Lisa A., Babu, Tara M., Kottkamp, Angelica C., Luetkemeyer, Anne F., Immergluck, Lilly C., Presti, Rachel M., Bäcker, Martín, Winokur, Patricia L., Mahgoub, Siham M., Goepfert, Paul A., Fusco, Dahlene N., Malkin, Elissa, Bethony, Jeffrey M., Walsh, Edward E., Graciaa, Daniel S., Samaha, Hady, Sherman, Amy C., Walsh, Stephen R., Abate, Getahun, Oikonomopoulou, Zacharoula, El Sahly, Hana M., Martin, Thomas C. S., Kamidani, Satoshi, Smith, Michael J., Ladner, Benjamin G., Porterfield, Laura, Dunstan, Maya, Wald, Anna, Davis, Tamia, Atmar, Robert L., Mulligan, Mark J., Lyke, Kirsten E., Posavad, Christine M., Meagher, Megan A., Stephens, David S., Neuzil, Kathleen M., Abebe, Kuleni, Hill, Heather, Albert, Jim, Telu, Kalyani, Mu, Jinjian, Lewis, Teri C., Giebeig, Lisa A., Eaton, Amanda, Netzl, Antonia, Wilks, Samuel H., Türeli, Sina, Makhene, Mamodikoe, Crandon, Sonja, Montefiori, David C., Makowski, Mat, Smith, Derek J., Nayak, Seema U., Roberts, Paul C., and Beigel, John H.

Published
2023
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5. Immunogenicity of NVX-CoV2373 heterologous boost against SARS-CoV-2 variants

Author

Lyke, Kirsten E., Atmar, Robert L., Dominguez Islas, Clara, Posavad, Christine M., Deming, Meagan E., Branche, Angela R., Johnston, Christine, El Sahly, Hana M., Edupuganti, Srilatha, Mulligan, Mark J., Jackson, Lisa A., Rupp, Richard E., Rostad, Christina A., Coler, Rhea N., Bäcker, Martín, Kottkamp, Angelica C., Babu, Tara M., Dobrzynski, David, Martin, Judith M., Brady, Rebecca C., Frenck, Jr., Robert W., Rajakumar, Kumaravel, Kotloff, Karen, Rouphael, Nadine, Szydlo, Daniel, PaulChoudhury, Rahul, Archer, Janet I., Crandon, Sonja, Ingersoll, Brian, Eaton, Amanda, Brown, Elizabeth R., McElrath, M. Juliana, Neuzil, Kathleen M., Stephens, David S., Post, Diane J., Lin, Bob C., Serebryannyy, Leonid, Beigel, John H., Montefiori, David C., and Roberts, Paul C.

Published
2023
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7. Phase 3 Safety and Efficacy of AZD1222 (ChAdOx1 nCoV-19) Covid-19 Vaccine

Author

Falsey, Ann R, Sobieszczyk, Magdalena E, Hirsch, Ian, Sproule, Stephanie, Robb, Merlin L, Corey, Lawrence, Neuzil, Kathleen M, Hahn, William, Hunt, Julie, Mulligan, Mark J, McEvoy, Charlene, DeJesus, Edwin, Hassman, Michael, Little, Susan J, Pahud, Barbara A, Durbin, Anna, Pickrell, Paul, Daar, Eric S, Bush, Larry, Solis, Joel, Carr, Quito Osuna, Oyedele, Temitope, Buchbinder, Susan, Cowden, Jessica, Vargas, Sergio L, Guerreros Benavides, Alfredo, Call, Robert, Keefer, Michael C, Kirkpatrick, Beth D, Pullman, John, Tong, Tina, Brewinski Isaacs, Margaret, Benkeser, David, Janes, Holly E, Nason, Martha C, Green, Justin A, Kelly, Elizabeth J, Maaske, Jill, Mueller, Nancy, Shoemaker, Kathryn, Takas, Therese, Marshall, Richard P, Pangalos, Menelas N, Villafana, Tonya, and Gonzalez-Lopez, Antonio

Subjects
Clinical Trials and Supportive Activities, Lung, Patient Safety, Vaccine Related, Prevention, Immunization, Clinical Research, Infectious Diseases, Emerging Infectious Diseases, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Adolescent, Adult, Aged, Aged, 80 and over, Antibodies, Neutralizing, Antibodies, Viral, COVID-19, ChAdOx1 nCoV-19, Chile, Double-Blind Method, Female, Humans, Immunogenicity, Vaccine, Male, Middle Aged, Peru, SARS-CoV-2, Spike Glycoprotein, Coronavirus, United States, Vaccine Efficacy, Young Adult, AstraZeneca AZD1222 Clinical Study Group, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundThe safety and efficacy of the AZD1222 (ChAdOx1 nCoV-19) vaccine in a large, diverse population at increased risk for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the United States, Chile, and Peru has not been known.MethodsIn this ongoing, double-blind, randomized, placebo-controlled, phase 3 clinical trial, we investigated the safety, vaccine efficacy, and immunogenicity of two doses of AZD1222 as compared with placebo in preventing the onset of symptomatic and severe coronavirus disease 2019 (Covid-19) 15 days or more after the second dose in adults, including older adults, in the United States, Chile, and Peru.ResultsA total of 32,451 participants underwent randomization, in a 2:1 ratio, to receive AZD1222 (21,635 participants) or placebo (10,816 participants). AZD1222 was safe, with low incidences of serious and medically attended adverse events and adverse events of special interest; the incidences were similar to those observed in the placebo group. Solicited local and systemic reactions were generally mild or moderate in both groups. Overall estimated vaccine efficacy was 74.0% (95% confidence interval [CI], 65.3 to 80.5; P

Published
2021

8. Immunogenicity and safety of varying dosages of a fifth-wave influenza A/H7N9 inactivated vaccine given with and without AS03 adjuvant in healthy adults

Author

Jackson, Lisa A., Stapleton, Jack T., Walter, Emmanuel B., Chen, Wilbur H., Rouphael, Nadine G., Anderson, Evan J., Neuzil, Kathleen M., Winokur, Patricia L., Smith, Michael J., Schmader, Kenneth E., Swamy, Geeta K., Thompson, Amelia B., Mulligan, Mark J., Rostad, Christina A., Cross, Kaitlyn, Tsong, Rachel, Wegel, Ashley, and Roberts, Paul C.

Published
2024
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9. mRNA COVID-19 vaccine elicits potent adaptive immune response without the acute inflammation of SARS-CoV-2 infection

Author

Ivanova, Ellie N., Shwetar, Jasmine, Devlin, Joseph C., Buus, Terkild B., Gray-Gaillard, Sophie, Koide, Akiko, Cornelius, Amber, Samanovic, Marie I., Herrera, Alberto, Mimitou, Eleni P., Zhang, Chenzhen, Karmacharya, Trishala, Desvignes, Ludovic, Ødum, Niels, Smibert, Peter, Ulrich, Robert J., Mulligan, Mark J., Koide, Shohei, Ruggles, Kelly V., Herati, Ramin S., and Koralov, Sergei B.

Published
2023
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10. Natural infection by Zika virus but not DNA vaccination consistently elicits antibodies that compete with two potently neutralising monoclonal antibodies targeting distinct epitopes

Author

Smith, Teresa C., Espinoza, Daniel O., Zhu, Yerun, Cardona-Ospina, Jaime A., Bowman, Natalie M., Becker-Dreps, Sylvia, Rouphael, Nadine, Rodriguez-Morales, Alfonso J., Bucardo, Filemon, Edupuganti, Srilatha, Premkumar, Lakshmanane, Mulligan, Mark J., de Silva, Aravinda M., and Collins, Matthew H.

Published
2023
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11. Heterologous cAd3-Ebola and MVA-EbolaZ vaccines are safe and immunogenic in US and Uganda phase 1/1b trials

Author

Happe, Myra, Hofstetter, Amelia R., Wang, Jing, Yamshchikov, Galina V., Holman, LaSonji A., Novik, Laura, Strom, Larisa, Kiweewa, Francis, Wakabi, Salim, Millard, Monica, Kelley, Colleen F., Kabbani, Sarah, Edupuganti, Srilatha, Beck, Allison, Kaltovich, Florence, Murray, Tamar, Tsukerman, Susanna, Carr, Derick, Ashman, Carl, Stanley, Daphne A., Ploquin, Aurélie, Bailer, Robert T., Schwartz, Richard, Cham, Fatim, Tindikahwa, Allan, Hu, Zonghui, Gordon, Ingelise J., Rouphael, Nadine, Houser, Katherine V., Coates, Emily E., Graham, Barney S., Koup, Richard A., Mascola, John R., Sullivan, Nancy J., Robb, Merlin L., Ake, Julie A., Lyke, Kirsten E., Mulligan, Mark J., Ledgerwood, Julie E., and Kibuuka, Hannah

Published
2024
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12. Author Correction: Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials

Author

Axfors, Cathrine, Schmitt, Andreas M., Janiaud, Perrine, van’t Hooft, Janneke, Abd-Elsalam, Sherief, Abdo, Ehab F., Abella, Benjamin S., Akram, Javed, Amaravadi, Ravi K., Angus, Derek C., Arabi, Yaseen M., Azhar, Shehnoor, Baden, Lindsey R., Baker, Arthur W., Belkhir, Leila, Benfield, Thomas, Berrevoets, Marvin A. H., Chen, Cheng-Pin, Chen, Tsung-Chia, Cheng, Shu-Hsing, Cheng, Chien-Yu, Chung, Wei-Sheng, Cohen, Yehuda Z., Cowan, Lisa N., Dalgard, Olav, de Almeida e Val, Fernando F., de Lacerda, Marcus V. G., de Melo, Gisely C., Derde, Lennie, Dubee, Vincent, Elfakir, Anissa, Gordon, Anthony C., Hernandez-Cardenas, Carmen M., Hills, Thomas, Hoepelman, Andy I. M., Huang, Yi-Wen, Igau, Bruno, Jin, Ronghua, Jurado-Camacho, Felipe, Khan, Khalid S., Kremsner, Peter G., Kreuels, Benno, Kuo, Cheng-Yu, Le, Thuy, Lin, Yi-Chun, Lin, Wu-Pu, Lin, Tse-Hung, Lyngbakken, Magnus Nakrem, McArthur, Colin, McVerry, Bryan J., Meza-Meneses, Patricia, Monteiro, Wuelton M., Morpeth, Susan C., Mourad, Ahmad, Mulligan, Mark J., Murthy, Srinivas, Naggie, Susanna, Narayanasamy, Shanti, Nichol, Alistair, Novack, Lewis A., O’Brien, Sean M., Okeke, Nwora Lance, Perez, Léna, Perez-Padilla, Rogelio, Perrin, Laurent, Remigio-Luna, Arantxa, Rivera-Martinez, Norma E., Rockhold, Frank W., Rodriguez-Llamazares, Sebastian, Rolfe, Robert, Rosa, Rossana, Røsjø, Helge, Sampaio, Vanderson S., Seto, Todd B., Shahzad, Muhammad, Soliman, Shaimaa, Stout, Jason E., Thirion-Romero, Ireri, Troxel, Andrea B., Tseng, Ting-Yu, Turner, Nicholas A., Ulrich, Robert J., Walsh, Stephen R., Webb, Steve A., Weehuizen, Jesper M., Velinova, Maria, Wong, Hon-Lai, Wrenn, Rebekah, Zampieri, Fernando G., Zhong, Wu, Moher, David, Goodman, Steven N., Ioannidis, John P. A., and Hemkens, Lars G.

Published
2024
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14. Distinct cellular immune properties in cerebrospinal fluid are associated with cognition in HIV-infected individuals initiating antiretroviral therapy

Author

Amundson, Beret, Lai, Lillin, Mulligan, Mark J, Xu, Yong, Zheng, Zidou, Kundu, Suprateek, Lennox, Jeffrey L, Waldrop-Valverde, Drenna, Franklin, Donald, Swaims-Kohlmeier, Alison, Letendre, Scott L, and Anderson, Albert M

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Immunology, Clinical Research, Mental Health, Pediatric AIDS, HIV/AIDS, Behavioral and Social Science, Neurosciences, Infectious Diseases, Pediatric, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Infection, Adult, Antiretroviral Therapy, Highly Active, Cognition, Female, Follow-Up Studies, HIV Infections, Humans, Immunity, Cellular, Male, Middle Aged, Retrospective Studies, Viral Load, HIV, AIDS, Cerebrospinal fluid, Flow cytometry, Neurology & Neurosurgery
Abstract

We examined the relationship between CSF immune cells and neurocognition and neuronal damage in HIV+ individuals before and after initiating antiretroviral therapy. Multivariate analysis at baseline indicated that greater CD4+ T cell abundance was associated with better cognition (p = .017), while higher CSF HIV RNA was associated with increased neuronal damage (p = .014). Following 24 weeks of antiretroviral therapy, CD8+ T cells, HLA-DR expressing CD4+ and CD8+ T cells, B cells, NK cells, and non-classical monocyte percentage decreased in CSF. Female gender was negatively associated with cognitive performance over time, as was higher percentage of HLA-DR expressing CD8+ T cells at baseline.

Published
2020

15. COVID-19 booster vaccination during pregnancy enhances maternal binding and neutralizing antibody responses and transplacental antibody transfer to the newborn

Author

Munoz, Flor M., Posavad, Christine M., Richardson, Barbra A., Badell, Martina L., Bunge, Katherine E., Mulligan, Mark J., Parameswaran, Lalitha, Kelly, Clifton W., Olson-Chen, Courtney, Novak, Richard M., Brady, Rebecca C., Pasetti, Marcela F., Defranco, Emily A., Gerber, Jeffrey S., Shriver, Mallory C., Suthar, Mehul S., Coler, Rhea N., Berube, Bryan J., Kim, So Hee, Piper, Jeanna M., Miller, Ashley M., Cardemil, Cristina V., Neuzil, Kathleen M., and Beigi, Richard H.

Published
2023
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18. Longitudinal study of immunity to SARS‐CoV2 in ocrelizumab‐treated MS patients up to 2 years after COVID‐19 vaccination

Author

Kister, Ilya, primary, Curtin, Ryan, additional, Piquet, Amanda L., additional, Borko, Tyler, additional, Pei, Jinglan, additional, Banbury, Barbara L, additional, Bacon, Tamar E., additional, Kim, Angie, additional, Tuen, Michael, additional, Velmurugu, Yogambigai, additional, Nyovanie, Samantha, additional, Selva, Sean, additional, Samanovic, Marie I., additional, Mulligan, Mark J., additional, Patskovsky, Yury, additional, Priest, Jessica, additional, Cabatingan, Mark, additional, Winger, Ryan C., additional, Krogsgaard, Michelle, additional, and Silverman, Gregg J., additional

Published
2024
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19. A Phase 2 Clinical Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of Different Prime-Boost Vaccination Schedules of 2013 and 2017 A(H7N9) Inactivated Influenza Virus Vaccines Administered with and without AS03 Adjuvant in Healthy US Adults

Author

Rostad, Christina A, primary, Atmar, Robert L, additional, Walter, Emmanuel B, additional, Frey, Sharon, additional, Meier, Jeffery L, additional, Sherman, Amy C, additional, Lai, Lilin, additional, Tsong, Rachel, additional, Kao, Carol M, additional, Raabe, Vanessa, additional, El Sahly, Hana M, additional, Keitel, Wendy A, additional, Whitaker, Jennifer A, additional, Smith, Michael J, additional, Schmader, Kenneth E, additional, Swamy, Geeta K, additional, Abate, Getahun, additional, Winokur, Patricia, additional, Buchanan, Wendy, additional, Cross, Kaitlyn, additional, Wegel, Ashley, additional, Xu, Yongxian, additional, Yildirim, Inci, additional, Kamidani, Satoshi, additional, Rouphael, Nadine, additional, Roberts, Paul C, additional, Mulligan, Mark J, additional, and Anderson, Evan J, additional

Published
2024
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22. SARS-CoV-2 inflammation durably imprints memory CD4 T cells.

Author

Gray-Gaillard, Sophie L., Solis, Sabrina M., Chen, Han M., Monteiro, Clarice, Ciabattoni, Grace, Samanovic, Marie I., Cornelius, Amber R., Williams, Tijaana, Geesey, Emilie, Rodriguez, Miguel, Ortigoza, Mila Brum, Ivanova, Ellie N., Koralov, Sergei B., Mulligan, Mark J., and Herati, Ramin Sedaghat

Subjects
IMMUNOLOGIC memory, SARS-CoV-2, BREAKTHROUGH infections, INFLAMMATION, T cells
Abstract

Memory CD4 T cells are critical to human immunity, yet it is unclear whether viral inflammation during memory formation has long-term consequences. Here, we compared transcriptional and epigenetic landscapes of Spike (S)–specific memory CD4 T cells in 24 individuals whose first exposure to S was via SARS-CoV-2 infection or mRNA vaccination. Nearly 2 years after memory formation, S-specific CD4 T cells established by infection remained enriched for transcripts related to cytotoxicity and for interferon-stimulated genes, likely because of a chromatin accessibility landscape altered by inflammation. Moreover, S-specific CD4 T cells primed by infection had reduced proliferative capacity in vitro relative to vaccine-primed cells. Furthermore, the transcriptional state of S-specific memory CD4 T cells was minimally altered by booster immunization and/or breakthrough infection. Thus, infection-associated inflammation durably imprints CD4 T cell memory, which affects the function of these cells and may have consequences for long-term immunity. Editor's summary: It is unclear whether the memory CD4 T cells generated via mRNA vaccination and via SARS-CoV-2 infection are comparable in terms of frequency and function. Gray-Gaillard et al. performed single-cell analysis of spike protein (S)–specific memory CD4 T cells taken from a longitudinal sample of individuals variously vaccinated against SARS-CoV-2 or naturally infected with the virus. Infection-primed S-specific memory CD4 T cells exhibited a durable transcriptional and epigenetic signature of inflammation, a cytotoxic profile, and a proliferative disadvantage compared with vaccine-primed memory CD4 T cells. Breakthrough infections did not generally alter the transcriptional profile of vaccine-primed memory T cells, although re-exposure to antigen accompanied by high levels of inflammation could alter the transcriptional profiles of these cells in a clonotype-specific manner. —Seth Thomas Scanlon [ABSTRACT FROM AUTHOR]

Published
2024
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23. A High Throughput Whole Blood Assay for Analysis of Multiple Antigen-Specific T Cell Responses in Human Mycobacterium tuberculosis Infection

Author

Whatney, Wendy E, Gandhi, Neel R, Lindestam Arlehamn, Cecilia S, Nizam, Azhar, Wu, Hao, Quezada, Melanie J, Campbell, Angela, Allana, Salim, Kabongo, Mbuyi Madeleine, Khayumbi, Jeremiah, Muchiri, Benson, Ongalo, Joshua, Tonui, Joan, Sasser, Loren E, Fergus, Tawania J, Ouma, Gregory Sadat, Ouma, Samuel Gurrion, Beck, Allison A, Mulligan, Mark J, Oladele, Alawode, Kaushal, Deepak, Cain, Kevin P, Waller, Lance, Blumberg, Henry M, Altman, John D, Ernst, Joel D, Rengarajan, Jyothi, and Day, Cheryl L

Subjects
Biodefense, HIV/AIDS, Immunization, Infectious Diseases, Emerging Infectious Diseases, Tuberculosis, Orphan Drug, Biotechnology, Vaccine Related, Prevention, Rare Diseases, Clinical Research, 2.1 Biological and endogenous factors, Aetiology, Infection, Good Health and Well Being, Cross-Sectional Studies, Hematologic Tests, High-Throughput Screening Assays, Humans, Immunologic Techniques, Longitudinal Studies, Reproducibility of Results, T-Lymphocytes, TBRU-ASTRa Study Group, Immunology
Abstract

Antigen-specific CD4 and CD8 T cells are important components of the immune response to Mycobacterium tuberculosis, yet little information is currently known regarding how the breadth, specificity, phenotype, and function of M. tuberculosis-specific T cells correlate with M. tuberculosis infection outcome in humans. To facilitate evaluation of human M. tuberculosis-specific T cell responses targeting multiple different Ags, we sought to develop a high throughput and reproducible T cell response spectrum assay requiring low blood sample volumes. We describe here the optimization and standardization of a microtiter plate-based, diluted whole blood stimulation assay utilizing overlapping peptide pools corresponding to a functionally diverse panel of 60 M. tuberculosis Ags. Using IFN-γ production as a readout of Ag specificity, the assay can be conducted using 50 μl of blood per test condition and can be expanded to accommodate additional Ags. We evaluated the intra- and interassay variability, and implemented testing of the assay in diverse cohorts of M. tuberculosis-unexposed healthy adults, foreign-born adults with latent M. tuberculosis infection residing in the United States, and tuberculosis household contacts with latent M. tuberculosis infection in a tuberculosis-endemic setting in Kenya. The M. tuberculosis-specific T cell response spectrum assay further enhances the immunological toolkit available for evaluating M. tuberculosis-specific T cell responses across different states of M. tuberculosis infection, and can be readily implemented in resource-limited settings. Moreover, application of the assay to longitudinal cohorts will facilitate evaluation of treatment- or vaccine-induced changes in the breadth and specificity of Ag-specific T cell responses, as well as identification of M. tuberculosis-specific T cell responses associated with M. tuberculosis infection outcomes.

Published
2018

25. Antibody Titers against Mpox Virus after Vaccination

Author

Kottkamp, Angelica C., primary, Samanovic, Marie I., additional, Duerr, Ralf, additional, Oom, Aaron L., additional, Belli, Hayley M., additional, Zucker, Jane R., additional, Rosen, Jennifer B., additional, and Mulligan, Mark J., additional

Published
2023
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26. Adjuvanted H5N1 influenza vaccine enhances both cross-reactive memory B cell and strain-specific naive B cell responses in humans

Author

Ellebedy, Ali H., Nachbagauer, Raffael, Jackson, Katherine J. L., Dai, Ya-Nan, Han, Julianna, Alsoussi, Wafaa B., Davis, Carl W., Stadlbauer, Daniel, Rouphael, Nadine, Chromikova, Veronika, McCausland, Megan, Chang, Cathy Y., Cortese, Mario, Bower, Mary, Chennareddy, Chakravarthy, Schmitz, Aaron J., Zarnitsyna, Veronika I., Lai, Lilin, Rajabhathor, Arvind, Kazemian, Cheyann, Antia, Rustom, Mulligan, Mark J., Ward, Andrew B., Fremont, Daved H., Boyd, Scott D., Pulendran, Bali, Krammer, Florian, and Ahmed, Rafi

Published
2020

28. The New York State SARS-CoV-2 Testing Consortium: Regional Communication in Response to the COVID-19 Pandemic

Author

Crawford, James M., Aguero-Rosenfeld, Maria E., Aifantis, Ioannis, Cadoff, Evan M., Cangiarella, Joan F., Cordon-Cardo, Carlos, Cushing, Melissa, Firpo-Betancourt, Aldolfo, Fox, Amy S., Furuya, Yoko, Hacking, Sean, Jhang, Jeffrey, Leonard, Debra G.B., Libien, Jenny, Loda, Massimo, Mendu, Damadora Rao, Mulligan, Mark J., Nasr, Michel R., Pecora, Nicole D., Pessin, Melissa S., Prystowsky, Michael B., Ramanathan, Lakshmi V., Rauch, Kathleen R., Riddell, Scott, Roach, Karen, Roth, Kevin A., Shroyer, Kenneth R., Smoller, Bruce R., Spitalnik, Steven L., Spitzer, Eric D., Tomaszewski, John E., Waltman, Susan, Willis, Loretta, and Sumer-King, Zeynep

Published
2021
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29. Maternal COVID-19 Vaccination and Prevention of Symptomatic Infection in Infants.

Author

Cardemil, Cristina V., Yi Cao, Posavad, Christine M., Badell, Martina L., Bunge, Katherine, Mulligan, Mark J., Parameswaran, Lalitha, Olson-Chen, Courtney, Novak, Richard M., Brady, Rebecca C., DeFranco, Emily, Gerber, Jeffrey S., Pasetti, Marcela, Shriver, Mallory, Coler, Rhea, Berube, Bryan, Suthar, Mehul S., Moreno, Alberto, Fei Gao, and Richardson, Barbra A.

Published
2024
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30. Antibody isotype diversity against SARS-CoV-2 is associated with differential serum neutralization capacities

Author

Noval, Maria G., Kaczmarek, Maria E., Koide, Akiko, Rodriguez-Rodriguez, Bruno A., Louie, Ping, Tada, Takuya, Hattori, Takamitsu, Panchenko, Tatyana, Romero, Larizbeth A., Teng, Kai Wen, Bazley, Andrew, de Vries, Maren, Samanovic, Marie I., Weiser, Jeffrey N., Aifantis, Ioannis, Cangiarella, Joan, Mulligan, Mark J., Desvignes, Ludovic, Dittmann, Meike, Landau, Nathaniel R., Aguero-Rosenfeld, Maria, Koide, Shohei, and Stapleford, Kenneth A.

Published
2021
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31. Author Correction: Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials

Author

Axfors, Cathrine, Schmitt, Andreas M., Janiaud, Perrine, van’t Hooft, Janneke, Abd-Elsalam, Sherief, Abdo, Ehab F., Abella, Benjamin S., Akram, Javed, Amaravadi, Ravi K., Angus, Derek C., Arabi, Yaseen M., Azhar, Shehnoor, Baden, Lindsey R., Baker, Arthur W., Belkhir, Leila, Benfield, Thomas, Berrevoets, Marvin A. H., Chen, Cheng-Pin, Chen, Tsung-Chia, Cheng, Shu-Hsing, Cheng, Chien-Yu, Chung, Wei-Sheng, Cohen, Yehuda Z., Cowan, Lisa N., Dalgard, Olav, de Almeida e Val, Fernando F., de Lacerda, Marcus V. G., de Melo, Gisely C., Derde, Lennie, Dubee, Vincent, Elfakir, Anissa, Gordon, Anthony C., Hernandez-Cardenas, Carmen M., Hills, Thomas, Hoepelman, Andy I. M., Huang, Yi-Wen, Igau, Bruno, Jin, Ronghua, Jurado-Camacho, Felipe, Khan, Khalid S., Kremsner, Peter G., Kreuels, Benno, Kuo, Cheng-Yu, Le, Thuy, Lin, Yi-Chun, Lin, Wu-Pu, Lin, Tse-Hung, Lyngbakken, Magnus Nakrem, McArthur, Colin, McVerry, Bryan J., Meza-Meneses, Patricia, Monteiro, Wuelton M., Morpeth, Susan C., Mourad, Ahmad, Mulligan, Mark J., Murthy, Srinivas, Naggie, Susanna, Narayanasamy, Shanti, Nichol, Alistair, Novack, Lewis A., O’Brien, Sean M., Okeke, Nwora Lance, Perez, Léna, Perez-Padilla, Rogelio, Perrin, Laurent, Remigio-Luna, Arantxa, Rivera-Martinez, Norma E., Rockhold, Frank W., Rodriguez-Llamazares, Sebastian, Rolfe, Robert, Rosa, Rossana, Røsjø, Helge, Sampaio, Vanderson S., Seto, Todd B., Shahzad, Muhammad, Soliman, Shaimaa, Stout, Jason E., Thirion-Romero, Ireri, Troxel, Andrea B., Tseng, Ting-Yu, Turner, Nicholas A., Ulrich, Robert J., Walsh, Stephen R., Webb, Steve A., Weehuizen, Jesper M., Velinova, Maria, Wong, Hon-Lai, Wrenn, Rebekah, Zampieri, Fernando G., Zhong, Wu, Moher, David, Goodman, Steven N., Ioannidis, John P. A., and Hemkens, Lars G.

Published
2021
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32. Immunologic mechanisms of seasonal influenza vaccination administered by microneedle patch from a randomized phase I trial

Author

Rouphael, Nadine G., Lai, Lilin, Tandon, Sonia, McCullough, Michele Paine, Kong, Yunchuan, Kabbani, Sarah, Natrajan, Muktha S., Xu, Yongxian, Zhu, Yerun, Wang, Dongli, O’Shea, Jesse, Sherman, Amy, Yu, Tianwei, Henry, Sebastien, McAllister, Devin, Stadlbauer, Daniel, Khurana, Surender, Golding, Hana, Krammer, Florian, Mulligan, Mark J., and Prausnitz, Mark R.

Published
2021
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33. Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials

Author

Axfors, Cathrine, Schmitt, Andreas M., Janiaud, Perrine, van’t Hooft, Janneke, Abd-Elsalam, Sherief, Abdo, Ehab F., Abella, Benjamin S., Akram, Javed, Amaravadi, Ravi K., Angus, Derek C., Arabi, Yaseen M., Azhar, Shehnoor, Baden, Lindsey R., Baker, Arthur W., Belkhir, Leila, Benfield, Thomas, Berrevoets, Marvin A. H., Chen, Cheng-Pin, Chen, Tsung-Chia, Cheng, Shu-Hsing, Cheng, Chien-Yu, Chung, Wei-Sheng, Cohen, Yehuda Z., Cowan, Lisa N., Dalgard, Olav, de Almeida e Val, Fernando F., de Lacerda, Marcus V. G., de Melo, Gisely C., Derde, Lennie, Dubee, Vincent, Elfakir, Anissa, Gordon, Anthony C., Hernandez-Cardenas, Carmen M., Hills, Thomas, Hoepelman, Andy I. M., Huang, Yi-Wen, Igau, Bruno, Jin, Ronghua, Jurado-Camacho, Felipe, Khan, Khalid S., Kremsner, Peter G., Kreuels, Benno, Kuo, Cheng-Yu, Le, Thuy, Lin, Yi-Chun, Lin, Wu-Pu, Lin, Tse-Hung, Lyngbakken, Magnus Nakrem, McArthur, Colin, McVerry, Bryan J., Meza-Meneses, Patricia, Monteiro, Wuelton M., Morpeth, Susan C., Mourad, Ahmad, Mulligan, Mark J., Murthy, Srinivas, Naggie, Susanna, Narayanasamy, Shanti, Nichol, Alistair, Novack, Lewis A., O’Brien, Sean M., Okeke, Nwora Lance, Perez, Léna, Perez-Padilla, Rogelio, Perrin, Laurent, Remigio-Luna, Arantxa, Rivera-Martinez, Norma E., Rockhold, Frank W., Rodriguez-Llamazares, Sebastian, Rolfe, Robert, Rosa, Rossana, Røsjø, Helge, Sampaio, Vanderson S., Seto, Todd B., Shahzad, Muhammad, Soliman, Shaimaa, Stout, Jason E., Thirion-Romero, Ireri, Troxel, Andrea B., Tseng, Ting-Yu, Turner, Nicholas A., Ulrich, Robert J., Walsh, Stephen R., Webb, Steve A., Weehuizen, Jesper M., Velinova, Maria, Wong, Hon-Lai, Wrenn, Rebekah, Zampieri, Fernando G., Zhong, Wu, Moher, David, Goodman, Steven N., Ioannidis, John P. A., and Hemkens, Lars G.

Published
2021
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34. Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults

Author

Mulligan, Mark J., Lyke, Kirsten E., Kitchin, Nicholas, Absalon, Judith, Gurtman, Alejandra, Lockhart, Stephen, and Neuzil, Kathleen

Subjects
Clinical trials -- Forecasts and trends, Market trend/market analysis, Environmental issues, Science and technology, Zoology and wildlife conservation, Comirnaty (Vaccine) -- Dosage and administration -- Testing
Abstract

In March 2020, the World Health Organization (WHO) declared coronavirus disease 2019 (COVID-19), which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).sup.1, a pandemic. With rapidly accumulating numbers of cases and deaths reported globally.sup.2, a vaccine is urgently needed. Here we report the available safety, tolerability and immunogenicity data from an ongoing placebo-controlled, observer-blinded dose-escalation study (ClinicalTrials.gov identifier NCT04368728) among 45 healthy adults (18-55 years of age), who were randomized to receive 2 doses--separated by 21 days--of 10 [mu]g, 30 [mu]g or 100 [mu]g of BNT162b1. BNT162b1 is a lipid-nanoparticle-formulated, nucleoside-modified mRNA vaccine that encodes the trimerized receptor-binding domain (RBD) of the spike glycoprotein of SARS-CoV-2. Local reactions and systemic events were dose-dependent, generally mild to moderate, and transient. A second vaccination with 100 [mu]g was not administered because of the increased reactogenicity and a lack of meaningfully increased immunogenicity after a single dose compared with the 30-[mu]g dose. RBD-binding IgG concentrations and SARS-CoV-2 neutralizing titres in sera increased with dose level and after a second dose. Geometric mean neutralizing titres reached 1.9-4.6-fold that of a panel of COVID-19 convalescent human sera, which were obtained at least 14 days after a positive SARS-CoV-2 PCR. These results support further evaluation of this mRNA vaccine candidate. In a dose-escalation study of the COVID-19 RNA vaccine BNT162b1 in 45 healthy adults, RBD-binding IgG concentrations and SARS-CoV-2 neutralizing titres in sera increased with dose level and after a second vaccine dose., Author(s): Mark J. Mulligan [sup.1] [sup.2] , Kirsten E. Lyke [sup.3] , Nicholas Kitchin [sup.4] , Judith Absalon [sup.5] , Alejandra Gurtman [sup.5] , Stephen Lockhart [sup.4] , Kathleen Neuzil [...]

Published
2020
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35. Phase 1 Open-Label Dose Escalation Trial for the Development of a Human Bacillus Calmette-Guérin Challenge Model for Assessment of Tuberculosis Immunity In Vivo

Author

Blazevic, Azra, primary, Edwards, Rachel L, additional, Xia, Mei, additional, Eickhoff, Christopher S, additional, Hamzabegovic, Fahreta, additional, Meza, Krystal A, additional, Ning, Huan, additional, Tennant, Janice, additional, Mosby, Karla J, additional, Ritchie, James C, additional, Girmay, Tigisty, additional, Lai, Lilin, additional, McCullough, Michele, additional, Beck, Allison, additional, Kelley, Colleen, additional, Edupuganti, Srilatha, additional, Kabbani, Sarah, additional, Buchanan, Wendy, additional, Makhene, Mamodikoe K, additional, Voronca, Delia, additional, Cherikh, Sami, additional, Goll, Johannes B, additional, Rouphael, Nadine G, additional, Mulligan, Mark J, additional, and Hoft, Daniel F, additional

Published
2023
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36. 1629. Acceptability and Trust in the Low-dose Intradermal Mpox Vaccine: a Knowledge, Attitudes and Practices Sub-analysis of the Observational Study of Mpox Immunity (OSMI) in NYC

Author

Carmody, Ellie, primary, Parameswaran, Lalitha, additional, Wilson, Kesi K, additional, Kottkamp, Angelica C, additional, Frank, Olivia, additional, Engelson, Celia, additional, Davis, Tamia S, additional, Noriega, Irma, additional, Callahan, Jacqueline, additional, Yip, Samantha, additional, Youn, Heekoung, additional, Rettig, Stephanie, additional, Wagner, Julia, additional, Nweke, Samuel, additional, Suman, Pamela, additional, Samanovic, Marie I, additional, Duerr, Ralf, additional, Haiken, Sarah, additional, and Mulligan, Mark J, additional

Published
2023
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37. 462. Infant antibody titers at birth following maternal COVID-19 vaccination and protection against infection in the first 6 months of life

Author

Cardemil, Cristina, primary, Munoz, Flor M, additional, Cao, Yi, additional, Gao, Fei, additional, Posavad, Christine M, additional, Badell, Martina L, additional, Bunge, Katherine E, additional, Mulligan, Mark J, additional, Parameswaran, Lalitha, additional, Olson-Chen, Courtney, additional, Novak, Richard M, additional, Brady, Rebecca C, additional, DeFranco, Emily A, additional, Gerber, Jeffrey S, additional, Pasetti, Marcela, additional, Shriver, Mallory C, additional, Coler, Rhea, additional, Berube, Bryan J, additional, Richardson, Barbra A, additional, Beigi, Richard H, additional, Neuzil, Kathy M, additional, and Brown, Elizabeth R, additional

Published
2023
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38. 1495. Mpox Vaccine Immunity in People Living with HIV (PLWH) During The 2022 Mpox Outbreak in New York City

Author

Kottkamp, Angelica C, primary, Oom, Aaron, additional, Wilson, Kesi K, additional, Rettig, Stephanie, additional, Frank, Olivia, additional, Engelson, Celia, additional, Davis, Tamia S, additional, Noriega, Irma, additional, Callahan, Jacqueline, additional, Yip, Samantha, additional, Youn, Heekoung, additional, Wagner, Julia, additional, Carmody, Ellie, additional, Parameswaran, Lalitha, additional, Tuen, Michael, additional, Wilson, Jimmy P, additional, Goins, Shelby J, additional, Zhao, Lisa, additional, Nweke, Samuel, additional, Haiken, Sarah, additional, Suman, Pamela, additional, Dontino, Amanda, additional, Rosen, Jennifer, additional, Zucker, Jane R, additional, Duerr, Ralf, additional, Samanovic, Marie I, additional, and Mulligan, Mark J, additional

Published
2023
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39. Immune response, phenotyping and molecular graft surveillance in kidney transplant recipients following severe acute respiratory syndrome coronavirus 2 vaccination

Author

Ali, Nicole M, primary, Herati, Ramin S, additional, Mehta, Sapna A, additional, Leonard, Jeanette, additional, Miles, Jake, additional, Lonze, Bonnie E, additional, DiMaggio, Charles, additional, Tatapudi, Vasishta S, additional, Stewart, Zoe A, additional, Alnazari, Nasser, additional, Neumann, Henry J, additional, Thomas, Jeffrey, additional, Cartiera, Katarzyna, additional, Weldon, Elaina, additional, Michael, Jennifer, additional, Hickson, Christopher, additional, Whiteson, Harris, additional, Khalil, Karen, additional, Stern, Jeffrey M, additional, Allen, Joseph R, additional, Tuen, Michael, additional, Gray‐Gaillard, Sophie L, additional, Solis, Sabrina M, additional, Samanovic, Marie I, additional, Mulligan, Mark J, additional, and Montgomery, Robert A, additional

Published
2023
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41. Theory-Based Analysis of Interest in an HIV Vaccine for Reasons Indicative of Risk Compensation among African American Women

Author

Painter, Julia E., Temple, Brandie S., Woods, Laura A., Cwiak, Carrie, Haddad, Lisa B., Mulligan, Mark J., and DiClemente, Ralph J.

Abstract

Licensure of an HIV vaccine could reduce or eliminate HIV among vulnerable populations. However, vaccine effectiveness could be undermined by risk compensation (RC), defined by an increase in risky behavior due to a belief that the vaccine will confer protection. Interest in an HIV vaccine for reasons indicative of RC may serve as an indicator of actual RC in a postlicensure era. This study assessed factors associated with interest in an HIV vaccine for reasons indicative of RC among African American women aged 18 to 55 years, recruited from a hospital-based family planning clinic in Atlanta, Georgia (N = 321). Data were collected using audio-computer-assisted surveys. Survey items were guided by risk homeostasis theory and social cognitive theory. Multivariable logistic regression was used to assess determinants of interest in an HIV vaccine for reasons indicative of RC. Thirty-eight percent of the sample expressed interest in an HIV vaccine for at least one reason indicative of RC. In the final model, interest in an HIV vaccine for reasons indicative of RC was positively associated with higher impulsivity, perceived benefits of sexual risk behaviors, and perceived benefits of HIV vaccination; it was negatively associated with having at least some college education, positive future orientation, and self-efficacy for sex refusal. Results suggest that demographic, personality, and theory-based psychosocial factors are salient to wanting an HIV vaccine for reasons indicative of RC, and underscore the need for risk-reduction counseling alongside vaccination during the eventual rollout of an HIV vaccine.

Published
2018
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42. Identification of immunodominant T cell epitopes induced by natural Zika virus infection

Author

Eickhoff, Christopher S., primary, Meza, Krystal A., additional, Terry, Frances E., additional, Colbert, Chase G., additional, Blazevic, Azra, additional, Gutiérrez, Andres H., additional, Stone, E. Taylor, additional, Brien, James D., additional, Pinto, Amelia K., additional, El Sahly, Hana M., additional, Mulligan, Mark J., additional, Rouphael, Nadine, additional, Alcaide, Maria L., additional, Tomashek, Kay M., additional, Focht, Chris, additional, Martin, William D., additional, Moise, Leonard, additional, De Groot, Anne S., additional, and Hoft, Daniel F., additional

Published
2023
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46. Innate, T-, and B-Cell Responses in Acute Human Zika Patients

Author

Emory Zika Patient Study Team, Lai, Lilin, Rouphael, Nadine, Xu, Yongxian, Natrajan, Muktha S., Beck, Allison, Hart, Mari, Feldhammer, Matthew, Feldpausch, Amanda, Hill, Charles, Wu, Henry, Fairley, Jessica K., Lankford-Turner, Pamela, Kasher, Nicole, Rago, Patrick, Hu, Yi-Juan, Edupuganti, Srilatha, Patel, Shital M., Murray, Kristy O., and Mulligan, Mark J.

Published
2018

49. Randomized clinical trial of a single versus a double dose of 13-valent pneumococcal conjugate vaccine in adults 55 through 74 years of age previously vaccinated with 23-valent pneumococcal polysaccharide vaccine

Author

Jackson, Lisa A., El Sahly, Hana M., George, Sarah, Winokur, Patricia, Edwards, Kathryn, Brady, Rebecca C., Rouphael, Nadine, Keitel, Wendy A., Mulligan, Mark J., Burton, Robert L., Nakamura, Aya, Ferreria, Jennifer, and Nahm, Moon H.

Published
2018
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50. Higher T-Cell Responses Induced by DNA/rAd5 HIV-1 Preventive Vaccine Are Associated With Lower HIV-1 Infection Risk in an Efficacy Trial

Author

Janes, Holly E., Cohen, Kristen W., Frahm, Nicole, De Rosa, Stephen C., Sanchez, Brittany, Hural, John, Magaret, Craig A., Karuna, Shelly, Bentley, Carter, Gottardo, Raphael, Finak, Greg, Grove, Douglas, Shen, Mingchao, Graham, Barney S., Koup, Richard A., Mulligan, Mark J., Koblin, Beryl, Buchbinder, Susan P., Keefer, Michael C., Adams, Elizabeth, Anude, Chuka, Corey, Lawrence, Sobieszczyk, Magdalena, Hammer, Scott M., Gilbert, Peter B., and McElrath, M. Juliana

Published
2017

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