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156 results on '"Hyrien, Ollivier"'

1. Quantifying how single dose Ad26.COV2.S vaccine efficacy depends on Spike sequence features.

Author

Magaret, Craig, Li, Li, deCamp, Allan, Rolland, Morgane, Juraska, Michal, Williamson, Brian, Ludwig, James, Molitor, Cindy, Benkeser, David, Luedtke, Alex, Simpkins, Brian, Heng, Fei, Sun, Yanqing, Carpp, Lindsay, Bai, Hongjun, Dearlove, Bethany, Giorgi, Elena, Jongeneelen, Mandy, Brandenburg, Boerries, McCallum, Matthew, Bowen, John, Veesler, David, Sadoff, Jerald, Gray, Glenda, Roels, Sanne, Vandebosch, An, Stieh, Daniel, Le Gars, Mathieu, Vingerhoets, Johan, Grinsztejn, Beatriz, Goepfert, Paul, de Sousa, Leonardo, Silva, Mayara, Casapia, Martin, Losso, Marcelo, Gaur, Aditya, Bekker, Linda-Gail, Garrett, Nigel, Truyers, Carla, Van Dromme, Ilse, Swann, Edith, Marovich, Mary, Follmann, Dean, Neuzil, Kathleen, Corey, Lawrence, Greninger, Alexander, Roychoudhury, Pavitra, Hyrien, Ollivier, Gilbert, Peter, and Little, Susan

Subjects
Humans, Ad26COVS1, COVID-19, SARS-CoV-2, Vaccine Efficacy, Amino Acids, Antibodies, Viral, Antibodies, Neutralizing
Abstract

In the ENSEMBLE randomized, placebo-controlled phase 3 trial (NCT04505722), estimated single-dose Ad26.COV2.S vaccine efficacy (VE) was 56% against moderate to severe-critical COVID-19. SARS-CoV-2 Spike sequences were determined from 484 vaccine and 1,067 placebo recipients who acquired COVID-19. In this set of prespecified analyses, we show that in Latin America, VE was significantly lower against Lambda vs. Reference and against Lambda vs. non-Lambda [family-wise error rate (FWER) p

Published
2024

2. Neutralizing antibody correlate of protection against severe-critical COVID-19 in the ENSEMBLE single-dose Ad26.COV2.S vaccine efficacy trial

Author

Carpp, Lindsay N., Hyrien, Ollivier, Fong, Youyi, Benkeser, David, Roels, Sanne, Stieh, Daniel J., Van Dromme, Ilse, Van Roey, Griet A., Kenny, Avi, Huang, Ying, Carone, Marco, McDermott, Adrian B., Houchens, Christopher R., Martins, Karen, Jayashankar, Lakshmi, Castellino, Flora, Amoa-Awua, Obrimpong, Basappa, Manjula, Flach, Britta, Lin, Bob C., Moore, Christopher, Naisan, Mursal, Naqvi, Muhammed, Narpala, Sandeep, O’Connell, Sarah, Mueller, Allen, Serebryannyy, Leo, Castro, Mike, Wang, Jennifer, Petropoulos, Christos J., Luedtke, Alex, Lu, Yiwen, Yu, Chenchen, Juraska, Michal, Hejazi, Nima S., Wolfe, Daniel N., Sadoff, Jerald, Gray, Glenda E., Grinsztejn, Beatriz, Goepfert, Paul A., Bekker, Linda-Gail, Gaur, Aditya H., Veloso, Valdilea G., Randhawa, April K., Andrasik, Michele P., Hendriks, Jenny, Truyers, Carla, Vandebosch, An, Struyf, Frank, Schuitemaker, Hanneke, Douoguih, Macaya, Kublin, James G., Corey, Lawrence, Neuzil, Kathleen M., Follmann, Dean, Koup, Richard A., Donis, Ruben O., and Gilbert, Peter B.

Published
2024
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4. Human immunoglobulin gene allelic variation impacts germline-targeting vaccine priming

Author

deCamp, Allan C., Corcoran, Martin M., Fulp, William J., Willis, Jordan R., Cottrell, Christopher A., Bader, Daniel L. V., Kalyuzhniy, Oleksandr, Leggat, David J., Cohen, Kristen W., Hyrien, Ollivier, Menis, Sergey, Finak, Greg, Ballweber-Fleming, Lamar, Srikanth, Abhinaya, Plyler, Jason R., Rahaman, Farhad, Lombardo, Angela, Philiponis, Vincent, Whaley, Rachael E., Seese, Aaron, Brand, Joshua, Ruppel, Alexis M., Hoyland, Wesley, Mahoney, Celia R., Cagigi, Alberto, Taylor, Alison, Brown, David M., Ambrozak, David R., Sincomb, Troy, Mullen, Tina-Marie, Maenza, Janine, Kolokythas, Orpheus, Khati, Nadia, Bethony, Jeffrey, Roederer, Mario, Diemert, David, Koup, Richard A., Laufer, Dagna S., McElrath, Juliana M., McDermott, Adrian B., Karlsson Hedestam, Gunilla B., and Schief, William R.

Published
2024
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6. Immune correlates analysis of the ENSEMBLE single Ad26.COV2.S dose vaccine efficacy clinical trial.

Author

Fong, Youyi, McDermott, Adrian, Benkeser, David, Roels, Sanne, Stieh, Daniel, Vandebosch, An, Le Gars, Mathieu, Van Roey, Griet, Houchens, Christopher, Martins, Karen, Jayashankar, Lakshmi, Castellino, Flora, Amoa-Awua, Obrimpong, Basappa, Manjula, Flach, Britta, Lin, Bob, Moore, Christopher, Naisan, Mursal, Naqvi, Muhammed, Narpala, Sandeep, OConnell, Sarah, Mueller, Allen, Serebryannyy, Leo, Castro, Mike, Wang, Jennifer, Petropoulos, Christos, Luedtke, Alex, Hyrien, Ollivier, Lu, Yiwen, Yu, Chenchen, Borate, Bhavesh, van der Laan, Lars, Hejazi, Nima, Kenny, Avi, Carone, Marco, Wolfe, Daniel, Sadoff, Jerald, Gray, Glenda, Grinsztejn, Beatriz, Goepfert, Paul, Little, Susan, Paiva de Sousa, Leonardo, Maboa, Rebone, Randhawa, April, Andrasik, Michele, Hendriks, Jenny, Truyers, Carla, Struyf, Frank, Schuitemaker, Hanneke, Douoguih, Macaya, Kublin, James, Corey, Lawrence, Neuzil, Kathleen, Carpp, Lindsay, Follmann, Dean, Gilbert, Peter, Koup, Richard, and Donis, Ruben

Subjects
Humans, Ad26COVS1, COVID-19, ChAdOx1 nCoV-19, 2019-nCoV Vaccine mRNA-1273, Vaccine Efficacy, Antibodies, Neutralizing
Abstract

Measuring immune correlates of disease acquisition and protection in the context of a clinical trial is a prerequisite for improved vaccine design. We analysed binding and neutralizing antibody measurements 4 weeks post vaccination as correlates of risk of moderate to severe-critical COVID-19 through 83 d post vaccination in the phase 3, double-blind placebo-controlled phase of ENSEMBLE, an international randomized efficacy trial of a single dose of Ad26.COV2.S. We also evaluated correlates of protection in the trial cohort. Of the three antibody immune markers we measured, we found most support for 50% inhibitory dilution (ID50) neutralizing antibody titre as a correlate of risk and of protection. The outcome hazard ratio was 0.49 (95% confidence interval 0.29, 0.81; P = 0.006) per 10-fold increase in ID50; vaccine efficacy was 60% (43%, 72%) at non-quantifiable ID50 (

Published
2022

7. Mosaic HIV-1 vaccine regimen in southern African women (Imbokodo/HVTN 705/HPX2008): a randomised, double-blind, placebo-controlled, phase 2b trial

Author

Allagappen, Jon, Andriesen, Jessica, Ayres, Alison, Bekker, Linda-Gail, Borremans, Caroline, Brumskine, William, Chilengi, Roma, Dubula, Thozama, Garrett, Nigel, Gelderblom, Huub, Gill, Katherine, Hoosain, Zaheer, Hosseinipour, Mina, Hutter, Julia, Inambao, Mubiana, Innes, Craig, Kilembe, William, Kotze, Philippus, Kotze, Sheena, Laher, Fatima, Laszlo, Imre, Lazarus, Erica, Malahleha, Mookho, Mathebula, Matsontso, Matoga, Mitch, McClennen, Rachael, Mda, Pamela, Meerts, Peter, Naicker, Vimla, Naidoo, Logashvari, Philip, Tricia, Pitsi, Annah, Scheppler, Lorenz, Sopher, Carrie, Takuva, Simbarashe G., Viegas, Edna, Weijtens, Mo, Yuan, Olive, Gray, Glenda E, Mngadi, Kathryn, Lavreys, Ludo, Nijs, Steven, Gilbert, Peter B, Hural, John, Hyrien, Ollivier, Juraska, Michal, Luedtke, Alex, Mann, Philipp, McElrath, M Juliana, Odhiambo, Jackline A, Stieh, Daniel J, van Duijn, Janine, Takalani, Azwidihwi N, Willems, Wouter, Tapley, Asa, Tomaras, Georgia D, Van Hoof, Johan, Schuitemaker, Hanneke, Swann, Edith, Barouch, Dan H, Kublin, James G, Corey, Lawrence, Pau, Maria G, Buchbinder, Susan, and Tomaka, Frank

Published
2024
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8. Immune correlates analysis of the Imbokodo (HVTN 705/HPX2008) efficacy trial of a mosaic HIV-1 vaccine regimen evaluated in Southern African people assigned female sex at birth: a two-phase case-control study

Author

Allagappen, Jon, Andriesen, Jessica, Ayres, Alison, Baral, Saman, Bekker, Linda-Gail, Besethi, Asiphe, Borremans, Caroline, Braams, Esmee, Brackett, Caroline, Brumskine, William, Chilengi, Roma, Choi, Rachel, Dubula, Thozama, Dumas, Jaiden Seongmi, Dunn, Brooke, Etikala, Radhika, Euler, Zelda, Everett, Sarah, Garrett, Nigel, Gelderblom, Huub, Gill, Katherine, Gillespie, Kevin, Goedhart, Dimitri, Goosmann, Erik, Grant, Shannon, Hands, Ellie, Haynes, Barton, Herringer, Bronwill, Hoosain, Zaheer, Hosseinipour, Mina, Hunidzarira, Portia, Hutter, Julia, Inambao, Mubiana, Innes, Craig, Keyes, Taylor, Kilembe, William, Kotze, Philippus, Kotze, Sheena, Laher, Fatima, Laszlo, Imre, Lazarus, Erica, Liao, Hua-Xin, Lin, Yong, Lu, Helen, Lucas, Judith, Malahleha, Mookho, McNair, Tara, Meerts, Peter, Mgaga, Zinhle, Montlha, Mahlodi, Mosito, Boitumelo, Moultrie, Andrew, Mudrak, Sarah, Oriol-Mathieu, Valérie, Sarzotti-Kelsoe, Marcella, Mathebula, Matson Tso, Matoga, Mitch, McClennen, Rachael, Mda, Pamela, Naicker, Vimla, Naidoo, Logashvari, Okkers, Cindy-Ann, Omarjee, Saleha, Pasmans, Hella, Philip, Tricia, Pinter, Abraham, Pitsi, Annah, Ramos, Ornelia, Randhawa, April, Roels, Sanne, Rohith, Shamiska, Rutten, Lucy, Sadoff, Jerald, Salinas, Gabriela, Salzgeber, Yvonne, Scheppler, Lorenz, Schwedhelm, Katharine, Schuller, Nicolette, Sharak, Angelina, Stanfield-Oakley, Sherry, Sopher, Carrie, Tafatatha, Terence, Takuva, Simbarashe G., Tang, Chan, Vandebosch, An, Viegas, Edna, Voillet, Valentin, Wegmann, Frank, Weijtens, Mo, Wilcox, Stephany, Williams, Anthony, Yu, Chenchen, Yu, Pei-Chun, Yuan, Olive, Zhang, Xuehan, Kenny, Avi, van Duijn, Janine, Dintwe, One, Heptinstall, Jack, Burnham, Randy, Sawant, Sheetal, Zhang, Lu, Mielke, Dieter, Khuzwayo, Sharon, Omar, Faatima Laher, Goodman, Derrick, Fong, Youyi, Benkeser, David, Zou, Rodger, Hural, John, Hyrien, Ollivier, Juraska, Michal, Luedtke, Alex, van der Laan, Lars, Giorgi, Elena E., Magaret, Craig, Carpp, Lindsay N., Pattacini, Laura, van de Kerkhof, Tom, Korber, Bette, Willems, Wouter, Fisher, Leigh H., Schuitemaker, Hanneke, Swann, Edith, Kublin, James G., Pau, Maria G., Buchbinder, Susan, Tomaka, Frank, Nijs, Steven, Lavreys, Ludo, Gelderblom, Huub C., Corey, Lawrence, Mngadi, Kathryn, Gray, Glenda E., Borducchi, Erica, Hendriks, Jenny, Seaton, Kelly E., Zolla-Pazner, Susan, Barouch, Dan H., Ferrari, Guido, De Rosa, Stephen C., McElrath, M Juliana, Andersen-Nissen, Erica, Stieh, Daniel J., Tomaras, Georgia D., and Gilbert, Peter B.

Published
2024
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9. Safety and pharmacokinetics of VRC07-523LS administered via different routes and doses (HVTN 127/HPTN 087): A Phase I randomized clinical trial

Author

Walsh, Stephen R., Gay, Cynthia L., Karuna, Shelly T., Hyrien, Ollivier, Skalland, Timothy, Mayer, Kenneth H., Sobieszczyk, Magdalena E., Baden, Lindsey R., Goepfert, Paul A., del Rio, Carlos, Pantaleo, Guiseppe, Andrew, Philip, Karg, Carissa, He, Zonglin, Lu, Huiyin, Paez, Carmen A., Baumblatt, Jane A. G., Polakowski, Laura L., Chege, Wairimu, Anderson, Maija A., Janto, Sophie, Han, Xue, Huang, Yunda, Dumond, Julie, Ackerman, Margaret E., McDermott, Adrian B., Flach, Britta, Piwowar-Manning, Estelle, Seaton, Kelly, Tomaras, Georgia D., Montefiori, David C., Gama, Lucio, and Mascola, John R.

Subjects
AIDS vaccines -- Physiological aspects -- Dosage and administration, HIV infection -- Prevention, Biological sciences
Abstract

Background Broadly neutralizing antibodies (bnAbs) are a promising approach for HIV-1 prevention. In the Antibody Mediated Prevention (AMP) trials, a CD4-binding site targeting bnAb, VRC01, administered intravenously (IV), demonstrated 75% prevention efficacy against highly neutralization-sensitive viruses but was ineffective against less sensitive viruses. VRC07-523LS is a next-generation bnAb targeting the CD4-binding site and was engineered for increased neutralization breadth and half-life. We conducted a multicenter, randomized, partially blinded Phase I clinical trial to evaluate the safety and serum concentrations of VRC07-523LS, administered in multiple doses and routes to healthy adults without HIV. Methods and findings Participants were recruited between 2 February 2018 and 9 October 2018. A total of 124 participants were randomized to receive 5 VRC07-523LS administrations via IV (T1: 2.5 mg/kg, T2: 5 mg/kg, T3: 20 mg/kg), subcutaneous (SC) (T4: 2.5 mg/kg, T5: 5 mg/kg), or intramuscular (IM) (T6: 2.5 mg/kg or P6: placebo) routes at 4-month intervals. Participants and site staff were blinded to VRC07-523LS versus placebo for the IM group, while all other doses and routes were open-label. Safety data were collected for 144 weeks following the first administration. VRC07-523LS serum concentrations were measured by ELISA through Day 112 in all participants and by binding antibody multiplex assay (BAMA) thereafter in 60 participants (10 per treatment group) through Day 784. Compartmental population pharmacokinetic (PK) analyses were conducted to evaluate the VRC07-523LS serum PK. Neutralization activity was measured in a TZM-bl assay and antidrug antibodies (ADAs) were assayed using a tiered bridging assay testing strategy. Injections and infusions were well tolerated, with mild pain or tenderness reported commonly in the SC and IM groups, and mild to moderate erythema or induration reported commonly in the SC groups. Infusion reactions reported in 3 of 20 participants in the 20 mg/kg IV group. Peak geometric mean (GM) concentrations (95% confidence intervals [95% CIs]) following the first administration were 29.0 [mu]g/mL (25.2, 33.4), 58.5 [mu]g/mL (49.4, 69.3), and 257.2 [mu]g/mL (127.5, 518.9) in T1-T3 with IV dosing; 10.8 [mu]g/mL (8.8, 13.3) and 22.8 [mu]g/mL (20.1, 25.9) in T4-T5 with SC dosing; and 16.4 [mu]g/mL (14.7, 18.2) in T6 with IM dosing. Trough GM (95% CIs) concentrations immediately prior to the second administration were 3.4 [mu]g/mL (2.5, 4.6), 6.5 [mu]g/mL (5.6, 7.5), and 27.2 [mu]g/mL (23.9, 31.0) with IV dosing; 0.97 [mu]g/mL (0.65, 1.4) and 3.1 [mu]g/mL (2.2, 4.3) with SC dosing, and 2.6 [mu]g/mL (2.05, 3.31) with IM dosing. Peak VRC07-523LS serum concentrations increased linearly with the administered dose. At a given dose, peak and trough concentrations, as well as serum neutralization titers, were highest in the IV groups, reflecting the lower bioavailability following SC and IM administration. A single participant was found to have low titer ADA at a lone time point. VRC07-523LS has an estimated mean half-life of 42 days across all doses and routes (95% CI: 40.5, 43.5), over twice as long as VRC01 (15 days). Conclusions VRC07-523LS was safe and well tolerated across a range of doses and routes and is a promising long-acting bnAb for inclusion in HIV-1 prevention regimens. Trial registration ClinicalTrials.gov/ NCT03387150 (posted on 21 December 2017)., Author(s): Stephen R. Walsh 1,2,*, Cynthia L. Gay 3, Shelly T. Karuna 4, Ollivier Hyrien 4, Timothy Skalland 4, Kenneth H. Mayer 2,5, Magdalena E. Sobieszczyk 6, Lindsey R. Baden [...]

Published
2024
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10. High-frequency home self-collection of capillary blood correlates IFI27 expression kinetics with SARS-CoV-2 viral clearance

Author

Lim, Fang Yun, Kim, Soo-Young, Kulkarni, Karisma N., Blazevic, Rachel L., Kimball, Louise E., Lea, Hannah G., Haack, Amanda J., Gower, Maia S., Stevens-Ayers, Terry, Starita, Lea M., Boeckh, Michael, Hyrien, Ollivier, Schiffer, Joshua T., Theberge, Ashleigh B., and Waghmare, Alpana

Subjects
Blood banks -- Health aspects, Health care industry
Abstract

To the Editor: Blood transcriptional profiling is a powerful tool to evaluate immune responses to infection; however, blood collection via traditional phlebotomy remains a barrier to precise characterization of the [...]

Published
2023

11. HIV BG505 SOSIP.664 trimer with 3M-052-AF/alum induces human autologous tier-2 neutralizing antibodies

Author

Hahn, William O., primary, Parks, K. Rachael, additional, Shen, Mingchao, additional, Ozorowski, Gabriel, additional, Janes, Holly, additional, Ballweber-Fleming, Lamar, additional, Woodward-Davis, Amanda, additional, Duplessis, Chris, additional, Tomei, Mark, additional, Dey, Antu K., additional, Sagawa, Zachary K., additional, De Rosa, Stephen C., additional, Seese, Aaron, additional, Siddaramaiah, Latha Kallur, additional, Stamatatos, Leonidas, additional, Lee, Wen-Hsin, additional, Sewall, Leigh M., additional, Karlinsey, Dalton, additional, Turner, Hannah L., additional, Rubin, Vanessa, additional, Furth, Sarah, additional, MacPhee, Kellie, additional, Duff, Michael, additional, Corey, Lawrence, additional, Keefer, Michael C., additional, Edupuganti, Srilattha, additional, Frank, Ian, additional, Maenza, Janine, additional, Baden, Lindsey R., additional, Hyrien, Ollivier, additional, Sanders, Rogier W., additional, Moore, John P., additional, Ward, Andrew B., additional, Tomaras, Georgia D., additional, Montefiori, David C., additional, Rouphael, Nadine, additional, and McElrath, M. Juliana, additional

Published
2024
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14. Subcritical multitype Markov branching processes with immigration generated by Poisson random measures.

Author

Slavtchova-Bojkova, Maroussia, Hyrien, Ollivier, and Yanev, Nikolay M.

Subjects
*RANDOM measures, *BRANCHING processes, *MARKOV processes, *EMIGRATION & immigration, *GAUSSIAN distribution
Abstract

We investigate multitype subcritical Markov branching processes with immigration driven by Poisson random measures. Limiting distributions are established for various rates of the Poisson measures when they are asymptotically equivalent to exponential or regularly varying functions. Results analogous to a strong LLN are proved, and limiting normal distributions are obtained when the local intensity of the Poisson measure increases with time. When it decreases, conditional limiting distributions are established. When the intensity converges to a constant, a stationary limiting distribution is obtained. The asymptotic behavior of the first and second moments of the processes is also investigated. [ABSTRACT FROM AUTHOR]

Published
2024
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16. Neutralizing antibody responses over time in demographically and clinically diverse individuals recovered from SARS-CoV-2 infection in the United States and Peru: A cohort study

Author

Karuna, Shelly, Li, Shuying Sue, Grant, Shannon, Walsh, Stephen R., Frank, Ian, Casapia, Martin, Trahey, Meg, Hyrien, Ollivier, Fisher, Leigh, Miner, Maurine D., Randhawa, April K., Polakowski, Laura, Kublin, James G., Corey, Lawrence, and Montefiori, David

Subjects
Antigen-antibody reactions -- Health aspects, Immune response -- Health aspects, Biological sciences
Abstract

Background People infected with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) experience a wide range of clinical manifestations, from asymptomatic and mild illness to severe illness and death, influenced by age and a variety of comorbidities. Neutralizing antibodies (nAbs) are thought to be a primary immune defense against the virus. Large, diverse, well-characterized cohorts of convalescent individuals provide standardized values to benchmark nAb responses to past SARS-CoV-2 infection and define potentially protective levels of immunity. Methods and findings This analysis comprises an observational cohort of 329 HIV-seronegative adults in the United States (n = 167) and Peru (n = 162) convalescing from SARS-CoV-2 infection from May through October 2020. The mean age was 48 years (range 18 to 86), 54% of the cohort overall was Hispanic, and 34% identified as White. nAb titers were measured in serum by SARS-CoV-2.D614G Spike-pseudotyped virus infection of 293T/ACE2 cells. Multiple linear regression was applied to define associations between nAb titers and demographic variables, disease severity and time from infection or disease onset, and comorbidities within and across US and Peruvian cohorts over time. nAb titers peaked 28 to 42 days post-diagnosis and were higher in participants with a history of severe Coronavirus Disease 2019 (COVID-19) (p 55 years, male sex assigned at birth, and, in some cases, body mass index were also independently associated with higher nAb titers, whereas hypertension was independently associated with lower nAb titers. nAb titers did not differ by race, underlying pulmonary disease or smoking. Two months post-enrollment, nAb ID50 (ID80) titers declined 3.5 (2.8)-fold overall. Study limitations in this observational, convalescent cohort include survivorship bias and missing early viral loads and acute immune responses to correlate with the convalescent responses we observed. Conclusions In summary, in our cohort, nAb titers after SARS-CoV-2 infection peaked approximately 1 month post-diagnosis and varied by age, sex assigned at birth, disease severity, and underlying comorbidities. Our data show great heterogeneity in nAb responses among people with recent COVID-19, highlighting the challenges of interpreting natural history studies and gauging responses to vaccines and therapeutics among people with recent infection. Our observations illuminate potential correlations of demographic and clinical characteristics with nAb responses, a key element for protection from COVID-19, thus informing development and implementation of preventative and therapeutic strategies globally. Trial registration ClinicalTrials.gov NCT04403880., Author(s): Shelly Karuna 1,*, Shuying Sue Li 1, Shannon Grant 1, Stephen R. Walsh 2, Ian Frank 3, Martin Casapia 4, Meg Trahey 1, Ollivier Hyrien 1, Leigh Fisher 1, [...]

Published
2021
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18. Supercritical Sevastyanov Branching Processes with Non-homogeneous Poisson Immigration

Author

Hyrien, Ollivier, Mitov, Kosto V., Yanev, Nikolay M., Bickel, Peter, Series editor, Diggle, Peter, Series editor, Fienberg, Stephen E., Series editor, Gather, Ursula, Series editor, Zeger, Scott, Series editor, del Puerto, Inés M., editor, González, Miguel, editor, Gutiérrez, Cristina, editor, Martínez, Rodrigo, editor, Minuesa, Carmen, editor, Molina, Manuel, editor, Mota, Manuel, editor, and Ramos, Alfonso, editor

Published
2016
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19. Quantifying how single dose Ad26.COV2.S vaccine efficacy depends on Spike sequence features

Author

Magaret, Craig, primary, Li, Li, additional, deCamp, Allan, additional, Rolland, Morgane, additional, Juraska, Michal, additional, Williamson, Brian, additional, Ludwig, James, additional, Molitor, Cindy, additional, Benkeser, David, additional, Luedtke, Alex, additional, Simpkins, Brian, additional, Carpp, Lindsay, additional, Bai, Hongjun, additional, Dearlove, Bethany, additional, Greninger, Alexander, additional, Roychoudhury, Pavitra, additional, Sadoff, Jerald, additional, Gray, Glenda, additional, Roels, Sanne, additional, Vandebosch, An, additional, Stieh, Daniel, additional, Gars, Mathieu Le, additional, Vingerhoets, Johan, additional, Grinsztejn, Beatriz, additional, Goepfert, Paul, additional, Truyers, Carla, additional, Dromme, Ilse Van, additional, Swann, Edith, additional, Marovich, Mary, additional, Follmann, Dean, additional, Neuzil, Kathleen, additional, Corey, Lawrence, additional, Hyrien, Ollivier, additional, de Sousa, Leonardo Paiva, additional, Casapia, Martin, additional, Losso, Marcelo, additional, Little, Susan, additional, Gaur, Aditya, additional, Bekker, Linda-Gail, additional, Garrett, Nigel, additional, Heng, Fei, additional, Sun, Yanqing, additional, and Gilbert, Peter, additional

Published
2023
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20. A first-in-human germline-targeting HIV nanoparticle vaccine induced broad and publicly targeted helper T cell responses

Author

Cohen, Kristen W., primary, De Rosa, Stephen C., additional, Fulp, William J., additional, deCamp, Allan C., additional, Fiore-Gartland, Andrew, additional, Mahoney, Celia R., additional, Furth, Sarah, additional, Donahue, Josh, additional, Whaley, Rachael E., additional, Ballweber-Fleming, Lamar, additional, Seese, Aaron, additional, Schwedhelm, Katharine, additional, Geraghty, Daniel, additional, Finak, Greg, additional, Menis, Sergey, additional, Leggat, David J., additional, Rahaman, Farhad, additional, Lombardo, Angela, additional, Borate, Bhavesh R., additional, Philiponis, Vincent, additional, Maenza, Janine, additional, Diemert, David, additional, Kolokythas, Orpheus, additional, Khati, Nadia, additional, Bethony, Jeffrey, additional, Hyrien, Ollivier, additional, Laufer, Dagna S., additional, Koup, Richard A., additional, McDermott, Adrian B., additional, Schief, William R., additional, and McElrath, M. Juliana, additional

Published
2023
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25. Human immunoglobulin gene allelic variation impacts germline-targeting vaccine priming

Author

deCamp, Allan, primary, Corcoran, Martin, additional, Fulp, William, additional, Willis, Jordan, additional, Cottrell, Christopher, additional, Bader, Daniel, additional, Kalyuzhniy, Oleksandr, additional, Leggat, David, additional, Cohen, Kristen, additional, Hyrien, Ollivier, additional, Menis, Sergey, additional, Finak, Greg, additional, Ballweber Fleming, Lamar, additional, Srikanth, Abhinaya, additional, Plyler, Jason, additional, Rahaman, Farhad, additional, Lombardo, Angela, additional, Philiponis, Vincent, additional, Whaley, Rachael, additional, Seese, Aaron, additional, Brand, Joshua, additional, Ruppel, Alexis, additional, Hoyland, Wesley, additional, Mahoney, Celia, additional, Cagigi, Alberto, additional, Taylor, Alison, additional, Brown, David, additional, Ambrozak, David, additional, Sincomb, Troy, additional, MULLEN, Tina-Marie, additional, Maenza, Janine, additional, Kolokythas, Orpheus, additional, Khati, Nadia, additional, Bethony, Jeffrey, additional, Roederer, Mario, additional, Diemert, David, additional, Koup, Richard, additional, Laufer, Dagna, additional, McElrath, M., additional, McDermott, Adrian, additional, Karlsson Hedestam, Gunilla, additional, and Schief, William, additional

Published
2023
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27. Human immunoglobulin gene allelic variation impacts germline-targeting vaccine priming

Author

deCamp, Allan C., Corcoran, Martin M., Fulp, William J., Willis, Jordan R., Cottrell, Christopher A., Bader, Daniel L.V., Kalyuzhniy, Oleksandr, Leggat, David J., Cohen, Kristen W., Hyrien, Ollivier, Menis, Sergey, Finak, Greg, Ballweber-Fleming, Lamar, Srikanth, Abhinaya, Plyler, Jason R., Rahaman, Farhad, Lombardo, Angela, Philiponis, Vincent, Whaley, Rachael E., Seese, Aaron, Brand, Joshua, Ruppel, Alexis M., Hoyland, Wesley, Mahoney, Celia R., Cagigi, Alberto, Taylor, Alison, Brown, David M., Ambrozak, David R., Sincomb, Troy, Mullen, Tina-Marie, Maenza, Janine, Kolokythas, Orpheus, Khati, Nadia, Bethony, Jeffrey, Roederer, Mario, Diemert, David, Koup, Richard A., Laufer, Dagna S., McElrath, Juliana M., McDermott, Adrian B., Hedestam, Gunilla B. Karlsson, and Schief, William R.

Subjects
Article
Abstract

Vaccine priming immunogens that activate germline precursors for broadly neutralizing antibodies (bnAbs) have promise for development of precision vaccines against major human pathogens. In a clinical trial of the eOD-GT8 60mer germline-targeting immunogen, higher frequencies of vaccine-induced VRC01-class bnAb-precursor B cells were observed in the high dose compared to the low dose group. Through immunoglobulin heavy chain variable (IGHV) genotyping, statistical modeling, quantification of IGHV1-2 allele usage and B cell frequencies in the naive repertoire for each trial participant, and antibody affinity analyses, we found that the difference between dose groups in VRC01-class response frequency was best explained by IGHV1-2 genotype rather than dose and was most likely due to differences in IGHV1-2 B cell frequencies for different genotypes. The results demonstrate the need to define population-level immunoglobulin allelic variations when designing germline-targeting immunogens and evaluating them in clinical trials.One-Sentence SummaryHuman genetic variation can modulate the strength of vaccine-induced broadly neutralizing antibody precursor B cell responses.

Published
2023
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28. Longitudinal home self-collection of capillary blood usinghomeRNA correlates interferon and innate viral defense pathways with SARS-CoV-2 viral clearance

Author

Lim, Fang Yun, primary, Kim, Soo-Young, additional, Kulkarni, Karisma N., additional, Blazevic, Rachel L., additional, Kimball, Louise E., additional, Lea, Hannah G., additional, Haack, Amanda J., additional, Gower, Maia. S., additional, Stevens-Ayers, Terry, additional, Starita, Lea M., additional, Boeckh, Michael, additional, Schiffer, Joshua T., additional, Hyrien, Ollivier, additional, Theberge, Ashleigh B., additional, and Waghmare, Alpana, additional

Published
2023
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29. Lower SARS-CoV-2–specific humoral immunity in people living with HIV-1 recovered from nonhospitalized COVID-19

Author

Schuster, Daniel J., primary, Karuna, Shelly, additional, Brackett, Caroline, additional, Wesley, Martina, additional, Li, Shuying S., additional, Eisel, Nathan, additional, Tenney, DeAnna, additional, Hilliard, Sir’Tauria, additional, Yates, Nicole L., additional, Heptinstall, Jack R., additional, Williams, LaTonya D., additional, Shen, Xiaoying, additional, Rolfe, Robert, additional, Cabello, Robinson, additional, Zhang, Lu, additional, Sawant, Sheetal, additional, Hu, Jiani, additional, Randhawa, April Kaur, additional, Hyrien, Ollivier, additional, Hural, John A., additional, Corey, Lawrence, additional, Frank, Ian, additional, Tomaras, Georgia D., additional, and Seaton, Kelly E., additional

Published
2022
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30. AAV-delivered gene editing for latent genital or orofacial herpes simplex virus infection reduces ganglionic viral load and minimizes subsequent viral shedding in mice

Author

Aubert, Martine, primary, Haick, Anoria K., additional, Strongin, Daniel E., additional, Klouser, Lindsay M., additional, Loprieno, Michelle A., additional, Stensland, Laurence, additional, Santo, Tracy K., additional, Huang, Meei-Li, additional, Hyrien, Ollivier, additional, Stone, Daniel, additional, and Jerome, Keith R., additional

Published
2022
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31. The quest for vaccine-induced immune correlates of protection against tuberculosis

Author

Nemes, Elisa, primary, Fiore-Gartland, Andrew, additional, Boggiano, Cesar, additional, Coccia, Margherita, additional, D’Souza, Patricia, additional, Gilbert, Peter, additional, Ginsberg, Ann, additional, Hyrien, Ollivier, additional, Laddy, Dominick, additional, Makar, Karen, additional, McElrath, M. Juliana, additional, Ramachandra, Lakshmi, additional, C. Schmidt, Alexander, additional, Shotorbani, Solmaz, additional, Sunshine, Justine, additional, Tomaras, Georgia, additional, Yu, Wen-Han, additional, Scriba, Thomas J., additional, and Frahm, Nicole, additional

Published
2022
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35. An international, interlaboratory ring trial confirms the feasibility of an extraction-less “direct” RT-qPCR method for reliable detection of SARS-CoV-2 RNA in clinical samples

Author

Mills, Margaret G., primary, Bruce, Emily, additional, Huang, Meei-Li, additional, Crothers, Jessica W., additional, Hyrien, Ollivier, additional, Oura, Christopher A. L., additional, Blake, Lemar, additional, Brown Jordan, Arianne, additional, Hester, Susan, additional, Wehmas, Leah, additional, Mari, Bernard, additional, Barby, Pascal, additional, Lacoux, Caroline, additional, Fassy, Julien, additional, Vial, Pablo, additional, Vial, Cecilia, additional, Martinez, Jose R. W., additional, Oladipo, Olusola Olalekan, additional, Inuwa, Bitrus, additional, Shittu, Ismaila, additional, Meseko, Clement A., additional, Chammas, Roger, additional, Santos, Carlos Ferreira, additional, Dionísio, Thiago José, additional, Garbieri, Thais Francini, additional, Parisi, Viviane Aparecida, additional, Mendes-Correa, Maria Cassia, additional, de Paula, Anderson V., additional, Romano, Camila M., additional, Góes, Luiz Gustavo Bentim, additional, Minoprio, Paola, additional, Campos, Angelica C., additional, Cunha, Marielton P., additional, Vilela, Ana Paula P., additional, Nyirenda, Tonney, additional, Mkakosya, Rajhab Sawasawa, additional, Muula, Adamson S., additional, Dumm, Rebekah E., additional, Harris, Rebecca M., additional, Mitchell, Constance A., additional, Pettit, Syril, additional, Botten, Jason, additional, and Jerome, Keith R., additional

Published
2022
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36. Lower SARS-CoV-2-Specific Humoral Immunity in People Living With HIV-1 Recovered From Symptomatic Non-Hospitalized COVID-19

Author

Schuster, Daniel J., primary, Karuna, Shelly T., additional, Brackett, Caroline, additional, Wesley, Martina, additional, Li, Shuying S., additional, Eisel, Nathan, additional, Tenney, DeAnna, additional, Hilliard, Sir'Tauria, additional, Yates, Nicole L., additional, Heptinstall, Jack, additional, Williams, LaTonya, additional, Shen, Xiaoying, additional, Rolfe, Robert, additional, Cabello, Robinson, additional, Zhang, Lu, additional, Sawant, Sheetal, additional, Hu, Jiani, additional, Randhawa, April, additional, Hyrien, Ollivier, additional, Hural, John, additional, Corey, Lawrence, additional, Frank, Ian, additional, Tomaras, Georgia D., additional, and Seaton, Kelly E., additional

Published
2022
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37. Poisson random measures and supercritical multitype Markov branching processes.

Author

Slavtchova-Bojkova, Maroussia, Hyrien, Ollivier, and Yanev, Nikolay M.

Subjects
*RANDOM measures, *BRANCHING processes, *MARKOV processes, *CELL populations, *GAUSSIAN distribution, *CELLULAR evolution
Abstract

We consider multitype Markov branching processes with immigration occurring at time points generated by Poisson random measures. These models find applications to study evolution of multitype cell populations in which new cells join the population according to a time-varying immigration mechanism. The focus of this paper is the supercritical case. We investigate the limiting behavior of the process for different rates of the Poisson random measures. In particular, we prove a result analogous to a strong LLN and establish limiting normal distributions. [ABSTRACT FROM AUTHOR]

Published
2023
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38. Poisson Random Measures and Noncritical Multitype Markov Branching Processes

Author

Slavtchova-Bojkova, Maroussia N., Hyrien, Ollivier, and Yanev, Nikolay M.

Subjects
Poisson Measures, Immigration, Multitype Markov Branching Processes, Limiting Distributions
Abstract

We investigate noncritical multi-type Markov branching processes with immigration generated by Poisson measures. Limiting distributions are obtained when the rates of the Poisson measures are asymptotically equivalent to exponential or regularly varying functions. In particular, results analogous to a strong LLN are presented, and limiting normal distributions are obtained when the rates increase. When the rates decrease, then conditional limiting distributions are established. A stationary limiting distribution is obtained when the mean Poisson measure grows linearly. The asymptotic behaviour of the first and second moments of the processes is also investigated. NFSR of the Ministry of Education and Science of Bulgaria, grant No. KP–06-H22/3.

Published
2021

40. A Deferred-Vaccination Design to Assess Durability of COVID-19 Vaccine Effect After the Placebo Group Is Vaccinated

Author

Follmann, Dean, primary, Fintzi, Jonathan, additional, Fay, Michael P., additional, Janes, Holly E., additional, Baden, Lindsey R., additional, El Sahly, Hana M., additional, Fleming, Thomas R., additional, Mehrotra, Devan V., additional, Carpp, Lindsay N., additional, Juraska, Michal, additional, Benkeser, David, additional, Donnell, Deborah, additional, Fong, Youyi, additional, Han, Shu, additional, Hirsch, Ian, additional, Huang, Ying, additional, Huang, Yunda, additional, Hyrien, Ollivier, additional, Luedtke, Alex, additional, Carone, Marco, additional, Nason, Martha, additional, Vandebosch, An, additional, Zhou, Honghong, additional, Cho, Iksung, additional, Gabriel, Erin, additional, Kublin, James G., additional, Cohen, Myron S., additional, Corey, Lawrence, additional, Gilbert, Peter B., additional, and Neuzil, Kathleen M., additional

Published
2021
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41. An international, interlaboratory ring trial confirms the feasibility of an open-source, extraction-less “direct” RT-qPCR method for reliable detection of SARS-CoV-2 RNA in clinical samples

Author

Mills, Margaret G., primary, Bruce, Emily, additional, Huang, Meei-Li, additional, Crothers, Jessica W., additional, Hyrien, Ollivier, additional, Oura, Christopher A. L., additional, Blake, Lemar, additional, Jordan, Arianne Brown, additional, Hester, Susan, additional, Wehmas, Leah, additional, Mari, Bernard, additional, Barby, Pascal, additional, Lacoux, Caroline, additional, Fassy, Julien, additional, Vial, Pablo, additional, Vial, Cecilia, additional, Martinez, Jose R.W., additional, Oladipo, Olusola Olalekan, additional, Inuwa, Bitrus, additional, Shittu, Ismaila, additional, Meseko, Clement A., additional, Chammas, Roger, additional, Santos, Carlos Ferreira, additional, José Dionísio, Thiago, additional, Garbieri, Thais Francini, additional, Parisi, Viviane Aparecida, additional, Mendes-Correa, Maria Cassia, additional, dePaula, Anderson V., additional, Romano, Camila M., additional, Góes, Luiz Gustavo Bentim, additional, Minoprio, Paola, additional, Campos, Angelica C., additional, Cunha, Marielton P., additional, Vilela, Ana Paula P., additional, Nyirenda, Tonney, additional, Mkakosya, Rajhab Sawasawa, additional, Muula, Adamson S., additional, Dumm, Rebekah E., additional, Harris, Rebecca M., additional, Mitchell, Constance A., additional, Pettit, Syril, additional, Botten, Jason, additional, and Jerome, Keith R., additional

Published
2021
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42. Clinical Endpoints for Evaluating Efficacy in COVID-19 Vaccine Trials

Author

Mehrotra, Devan V., primary, Janes, Holly E., additional, Fleming, Thomas R., additional, Annunziato, Paula W., additional, Neuzil, Kathleen M., additional, Carpp, Lindsay N., additional, Benkeser, David, additional, Brown, Elizabeth R., additional, Carone, Marco, additional, Cho, Iksung, additional, Donnell, Deborah, additional, Fay, Michael P., additional, Fong, Youyi, additional, Han, Shu, additional, Hirsch, Ian, additional, Huang, Ying, additional, Huang, Yunda, additional, Hyrien, Ollivier, additional, Juraska, Michal, additional, Luedtke, Alex, additional, Nason, Martha, additional, Vandebosch, An, additional, Zhou, Honghong, additional, Cohen, Myron S., additional, Corey, Lawrence, additional, Hartzel, Jonathan, additional, Follmann, Dean, additional, and Gilbert, Peter B., additional

Published
2021
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43. Assessing Durability of Vaccine Effect Following Blinded Crossover in COVID-19 Vaccine Efficacy Trials

Author

Follmann, Dean, primary, Fintzi, Jonathan, additional, Fay, Michael P., additional, Janes, Holly E., additional, Baden, Lindsey, additional, Sahly, Hana El, additional, Fleming, Thomas R., additional, Mehrotra, Devan V., additional, Carpp, Lindsay N., additional, Juraska, Michal, additional, Benkeser, David, additional, Donnell, Deborah, additional, Fong, Youyi, additional, Han, Shu, additional, Hirsch, Ian, additional, Huang, Ying, additional, Huang, Yunda, additional, Hyrien, Ollivier, additional, Luedtke, Alex, additional, Carone, Marco, additional, Nason, Martha, additional, Vandebosch, An, additional, Zhou, Honghong, additional, Cho, Iksung, additional, Gabriel, Erin, additional, Kublin, James G., additional, Cohen, Myron S., additional, Corey, Lawrence, additional, Gilbert, Peter B., additional, and Neuzil, Kathleen M., additional

Published
2020
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45. Use of 3M-052-AF with Alum adjuvant in HIV trimer vaccine induces human autologous neutralizing antibodies

Author

Hahn, William O., Parks, K. Rachael, Shen, Mingchao, Ozorowski, Gabriel, Janes, Holly, Ballweber-Fleming, Lamar, Woodward Davis, Amanda S., Duplessis, Chris, Tomai, Mark, Dey, Antu K., Sagawa, Zachary K., De Rosa, Stephen C., Seese, Aaron, Kallur Siddaramaiah, Latha, Stamatatos, Leonidas, Lee, Wen-Hsin, Sewall, Leigh M., Karlinsey, Dalton, Turner, Hannah L., Rubin, Vanessa, Furth, Sarah, MacPhee, Kellie, Duff, Michael, Corey, Lawrence, Keefer, Michael C., Edupuganti, Srilatha, Frank, Ian, Maenza, Janine, Baden, Lindsey R., Hyrien, Ollivier, Sanders, Rogier W., Moore, John P., Ward, Andrew B., Tomaras, Georgia D., Montefiori, David C., Rouphael, Nadine, and McElrath, M. Juliana

Abstract

Stabilized trimers preserving the native-like HIV envelope structure may be key components of a preventive HIV vaccine regimen to induce broadly neutralizing antibodies (bnAbs). We evaluated trimeric BG505 SOSIP.664 gp140 formulated with a novel TLR7/8 signaling adjuvant, 3M-052-AF/Alum, for safety, adjuvant dose-finding, and immunogenicity in a first-in-healthy adult (n = 17), randomized, and placebo-controlled trial (HVTN 137A). The vaccine regimen appeared safe. Robust, trimer-specific antibody, and B cell and CD4+ T cell responses emerged after vaccination. Five vaccinees developed serum autologous tier 2 nAbs (ID50 titer, 1:28-1:8647) after two to three doses targeting C3/V5 and/or V1/V2/V3 Env regions by electron microscopy and mutated pseudovirus-based neutralization analyses. Trimer-specific, B cell–derived monoclonal antibody activities confirmed these results and showed weak heterologous neutralization in the strongest responder. Our findings demonstrate the clinical utility of the 3M-052-AF/Alum adjuvant and support further improvements of trimer-based Env immunogens to focus responses on multiple broad nAb epitopes.

Published
2024
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46. SARS-CoV-2 Viral Load in the Nasopharynx at Time of First Infection Among Unvaccinated Individuals: A Secondary Cross-Protocol Analysis of 4 Randomized Trials.

Author

Fisher, Leigh H., Kee, Jia Jin, Liu, Albert, Espinosa, Claudia M., Randhawa, April K., Ludwig, James, Magaret, Craig A., Robinson, Samuel T., Gilbert, Peter B., Hyrien, Ollivier, Kublin, James G., Rouphael, Nadine, Falsey, Ann R., Sobieszczyk, Magdalena E., El Sahly, Hana M., Grinsztejn, Beatriz, Gray, Glenda E., Kotloff, Karen L., Gay, Cynthia L., and Leav, Brett

Published
2024
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49. Finite Mixtures of Nonlinear Mixed-Effects Models for Longitudinal Data

Author

Chen, Chongshu, Thurston, Sally W., Hyrien, Ollivier, Chen, Chongshu, Thurston, Sally W., and Hyrien, Ollivier

Abstract

Thesis (Ph.D.)--University of Rochester. School of Medicine & Dentistry. Dept. of Biostatistics & Computational Biology, 2017., Finite mixture models are increasingly used to model distributions in multivariate regression settings where outcomes and covariates exhibit heterogeneous relationships. When observations are collected repeatedly within subjects, for example longitudinally, these models must be adapted to account for potential dependencies. In this thesis, we consider a class of finite mixture regression models that is suitable for longitudinal data structures. The proposed model captures inter-subject variability and intra-subject dependencies with random effects and allows both mixing proportions and component densities to depend on covariates. We propose a new version of the stochastic approximation expectation maximization (SAEM) algorithm, which we call the Newton-Raphson SAEM (NR-SAEM) algorithm for maximum likelihood (ML) estimation. The implementation of our proposed algorithm requires sampling unobservable random effects from their posterior distributions using Markov Chain Monte Carlo (MCMC) methods, and reduces stochastic variability by estimating latent group indicators unconditional on random effects. The proposed method is demonstrated using both simulated data and real data of repeated hormone levels over a key period of the menstrual cycle. We compare the NR-SAEM algorithm to the standard expectation maximization (EM) and the mixture SAEM (MSAEM) algorithms. We find that the NR-SAEM algorithm performed comparably to the standard EM algorithm that converged to the ML estimators for finite mixture regression models with linear random effects, and it exhibited better convergence than the MSAEM algorithm in simulations. Application of our proposed model to the hormone level data suggests that women’s hormone trajectories over a key part of the menstrual cycle may follow more than one type of pattern, suggesting several subpopulations which differ with respect to the distributions of BMI and PFOS exposure.

Published
2019

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