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1. Protein Dose-Sparing Effect of AS01B Adjuvant in a Randomized Preventive HIV Vaccine Trial of ALVAC-HIV (vCP2438) and Adjuvanted Bivalent Subtype C gp120.

Author: Chirenje, Zvavahera, Laher, Fatima, Dintwe, One, Muyoyeta, Monde, deCamp, Allan, He, Zonglin, Grunenberg, Nicole, Laher Omar, Faatima, Seaton, Kelly, Polakowski, Laura, Woodward Davis, Amanda, Maganga, Lucas, Baden, Lindsey, Mayer, Kenneth, Kalams, Spyros, Keefer, Michael, Edupuganti, Srilatha, Rodriguez, Benigno, Frank, Ian, Scott, Hyman, Stranix-Chibanda, Lynda, Gurunathan, Sanjay, Koutsoukos, Marguerite, Van Der Meeren, Olivier, DiazGranados, Carlos, Paez, Carmen, Andersen-Nissen, Erica, Kublin, James, Corey, Lawrence, Ferrari, Guido, Tomaras, Georgia, and McElrath, M
Subjects: HIV, adjuvant, dose, vaccine, Humans, Female, Adjuvants, Immunologic, AIDS Vaccines, Adult, Male, Young Adult, HIV Infections, HIV Envelope Protein gp120, Adolescent, Double-Blind Method, HIV Antibodies, Squalene, Polysorbates, HIV-1, Viral Vaccines
Abstract: BACKGROUND: HVTN 120 is a phase 1/2a randomized double-blind placebo-controlled human immunodeficiency virus (HIV) vaccine trial that evaluated the safety and immunogenicity of ALVAC-HIV (vCP2438) and MF59- or AS01B-adjuvanted bivalent subtype C gp120 Env protein at 2 dose levels in healthy HIV-uninfected adults. METHODS: Participants received ALVAC-HIV (vCP2438) alone or placebo at months 0 and 1. At months 3 and 6, participants received either placebo, ALVAC-HIV (vCP2438) with 200 μg of bivalent subtype C gp120 adjuvanted with MF59 or AS01B, or ALVAC-HIV (vCP2438) with 40 μg of bivalent subtype C gp120 adjuvanted with AS01B. Primary outcomes were safety and immune responses. RESULTS: We enrolled 160 participants, 55% women, 18-40 years old (median age 24 years) of whom 150 received vaccine and 10 placebo. Vaccines were generally safe and well tolerated. At months 6.5 and 12, CD4+ T-cell response rates and magnitudes were higher in the AS01B-adjuvanted groups than in the MF59-adjuvanted group. At month 12, HIV-specific Env-gp120 binding antibody response magnitudes in the 40 μg gp120/AS01B group were higher than in either of the 200 μg gp120 groups. CONCLUSIONS: The 40 μg dose gp120/AS01B regimen elicited the highest CD4+ T-cell and binding antibody responses. Clinical Trials Registration . NCT03122223.
Published: 2024

2. 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

3. Polytopic fractional delivery of an HIV vaccine alters cellular responses and results in increased epitope breadth in a phase 1 randomized trial

Author: Miner, Maurine D, deCamp, Allan, Grunenberg, Nicole, De Rosa, Stephen C, Fiore-Gartland, Andrew, Bar, Katherine, Spearman, Paul, Allen, Mary, Yu, Pei-Chun, Manso, Bryce, Frahm, Nicole, Kalams, Spyros, Baden, Lindsey, Keefer, Michael C, Scott, Hyman M, Novak, Richard, Van Tieu, Hong, Tomaras, Georgia D, Kublin, James G, McElrath, M Juliana, Corey, Lawrence, Frank, Ian, Team, HVTN 085 Study, Kalichman, Artur, Edlefsen, Paul, Enama, Mary, Hural, John, Holt, Renee, Dunbar, Debora, Crawford, Dave, Maki, Ian, Johannessen, Jan, Estep, Scharla, Grigoriev, Yevgeny, Madenwald, Tamra, Hansen, Marianne, Holman, Drienna, Fair, Ramey, Meyer, Genevieve, and Luke-Kilolam, Anya
Subjects: Medical Microbiology, Biomedical and Clinical Sciences, Immunology, Infectious Diseases, Prevention, Biotechnology, Clinical Trials and Supportive Activities, HIV/AIDS, Immunization, Vaccine Related, Clinical Research, Prevention of disease and conditions, and promotion of well-being, 3.4 Vaccines, Infection, Good Health and Well Being, Humans, AIDS Vaccines, Epitopes, HIV Infections, CD4-Positive T-Lymphocytes, Vaccination, Immunoglobulin G, HIV, Fractionated delivery, Polytopic vaccination, Ad5, Epitope breadth, HVTN 085 Study Team, Clinical Sciences, Public Health and Health Services, Clinical sciences, Epidemiology
Abstract: BackgroundElicitation of broad immune responses is understood to be required for an efficacious preventative HIV vaccine. This Phase 1 randomized controlled trial evaluated whether administration of vaccine antigens separated at multiple injection sites vs combined, fractional delivery at multiple sites affected T-cell breadth compared to standard, single site vaccination.MethodsWe randomized 90 participants to receive recombinant adenovirus 5 (rAd5) vector with HIV inserts gag, pol and env via three different strategies. The Standard group received vaccine at a single anatomic site (n = 30) compared to two polytopic (multisite) vaccination groups: Separated (n = 30), where antigens were separately administered to four anatomical sites, and Fractioned (n = 30), where fractions of each vaccine component were combined and administered at four sites. All groups received the same total dose of vaccine.FindingsCD8 T-cell response rates and magnitudes were significantly higher in the Fractioned group than Standard for several antigen pools tested. CD4 T-cell response magnitudes to Pol were higher in the Separated than Standard group. T-cell epitope mapping demonstrated greatest breadth in the Fractioned group (median 8.0 vs 2.5 for Standard, Wilcoxon p = 0.03; not significant after multiplicity adjustment for co-primary endpoints). IgG binding antibody response rates to Env were higher in the Standard and Fractioned groups vs Separated group.InterpretationThis study shows that the number of anatomic sites for which a vaccine is delivered and distribution of its antigenic components influences immune responses in humans.FundingNational Institute of Allergy and Infectious Diseases, NIH.
Published: 2024

4. Risk of COVID-19 after natural infection or vaccination

Author: Rick, Anne-Marie, Laurens, Matthew B, Huang, Ying, Yu, Chenchen, Martin, Thomas CS, Rodriguez, Carina A, Rostad, Christina A, Maboa, Rebone M, Baden, Lindsey R, Sahly, Hana M El, Grinsztejn, Beatriz, Gray, Glenda E, Gay, Cynthia L, Gilbert, Peter B, Janes, Holly E, Kublin, James G, Huang, Yunda, Leav, Brett, Hirsch, Ian, Struyf, Frank, Dunkle, Lisa M, Neuzil, Kathleen M, Corey, Lawrence, Goepfert, Paul A, Walsh, Stephen R, Follmann, Dean, Kotloff, Karen L, Adams, Atoya, Miller, Eric, Rankin, Bruce G, Shinn, Steven, Nash, Marshall, Green, Sinikka L, Jacobsen, Colleen, Krishnankutty, Jayasree, Phungwayo, Sikhongi, Glover, Richard M, Slechta, Stacy, Holdeman, Troy, Hartvickson, Robyn, Grant, Amber, Poling, Terry L, Klein, Terry D, Klein, Thomas C, Klein, Tracy R, Smith, William B, Gibson, Richard L, Winbigler, Jennifer, Parker, Elizabeth, Wijewardane, Priyantha N, Bravo, Eric, Thessing, Jeffrey, Maxwell, Michelle, Horn, Amanda, Healy, Catherine Mary, Akamine, Christine, Chu, Laurence, Chouteau, R Michelle, Cotugno, Michael J, Bauer, George H, Hachigian, Greg, Oshita, Masaru, Cancilla, Michael, Kiersey, Kristen, Seger, William, Antwi, Mohammed, Green, Allison, Kim, Anthony, Desjardins, Michael, Johnson, Jennifer A, Sherman, Amy, Borger, Judith, Saleem, Nafisa, Solis, Joel, Medina, Martha Carmen, Keating, Westly, Garcia, Edgar, Bueno, Cynthia, Segall, Nathan, Denham, Douglas S, Weiss, Thomas, Avworo, Ayoade, Hedges, Parke, Strout, Cynthia Becher, Santiago, Rica, Davis, Yvonne, Howenstine, Patty, Bondell, Alison, Marks, Kristin, Wang, Tina, Wilkin, Timothy, Vogler, Mary, Johnston, Carrie, Andrasik, Michele P, Andriesen, Jessica G, Broder, Gail, Eaton, Niles, Gelderblom, Huub G, and McClennen, Rachael
Subjects: Biomedical and Clinical Sciences, Clinical Sciences, Immunization, Prevention, Clinical Research, Vaccine Related, Biotechnology, Coronaviruses, Clinical Trials and Supportive Activities, Infectious Diseases, Emerging Infectious Diseases, 6.1 Pharmaceuticals, 3.4 Vaccines, Infection, Good Health and Well Being, Humans, COVID-19, COVID-19 Vaccines, Pandemics, SARS-CoV-2, United States, Vaccination, Natural infection, Hybrid immunity, NIAID-funded COVID-19 Prevention Network, natural infection, hybrid immunity, vaccination, Public Health and Health Services, Clinical sciences, Epidemiology
Abstract: BackgroundWhile vaccines have established utility against COVID-19, phase 3 efficacy studies have generally not comprehensively evaluated protection provided by previous infection or hybrid immunity (previous infection plus vaccination). Individual patient data from US government-supported harmonized vaccine trials provide an unprecedented sample population to address this issue. We characterized the protective efficacy of previous SARS-CoV-2 infection and hybrid immunity against COVID-19 early in the pandemic over three-to six-month follow-up and compared with vaccine-associated protection.MethodsIn this post-hoc cross-protocol analysis of the Moderna, AstraZeneca, Janssen, and Novavax COVID-19 vaccine clinical trials, we allocated participants into four groups based on previous-infection status at enrolment and treatment: no previous infection/placebo; previous infection/placebo; no previous infection/vaccine; and previous infection/vaccine. The main outcome was RT-PCR-confirmed COVID-19 >7-15 days (per original protocols) after final study injection. We calculated crude and adjusted efficacy measures.FindingsPrevious infection/placebo participants had a 92% decreased risk of future COVID-19 compared to no previous infection/placebo participants (overall hazard ratio [HR] ratio: 0.08; 95% CI: 0.05-0.13). Among single-dose Janssen participants, hybrid immunity conferred greater protection than vaccine alone (HR: 0.03; 95% CI: 0.01-0.10). Too few infections were observed to draw statistical inferences comparing hybrid immunity to vaccine alone for other trials. Vaccination, previous infection, and hybrid immunity all provided near-complete protection against severe disease.InterpretationPrevious infection, any hybrid immunity, and two-dose vaccination all provided substantial protection against symptomatic and severe COVID-19 through the early Delta period. Thus, as a surrogate for natural infection, vaccination remains the safest approach to protection.FundingNational Institutes of Health.
Published: 2023

5. Omicron COVID-19 immune correlates analysis of a third dose of mRNA-1273 in the COVE trial

Author: Zhang, Bo, Fong, Youyi, Fintzi, Jonathan, Chu, Eric, Janes, Holly E., Kenny, Avi, Carone, Marco, Benkeser, David, van der Laan, Lars W. P., Deng, Weiping, Zhou, Honghong, Wang, Xiaowei, Lu, Yiwen, Yu, Chenchen, Borate, Bhavesh, Chen, Haiyan, Reeder, Isabel, Carpp, Lindsay N., Houchens, Christopher R., Martins, Karen, Jayashankar, Lakshmi, Huynh, Chuong, Fichtenbaum, Carl J., Kalams, Spyros, Gay, Cynthia L., Andrasik, Michele P., Kublin, James G., Corey, Lawrence, Neuzil, Kathleen M., Priddy, Frances, Das, Rituparna, Girard, Bethany, El Sahly, Hana M., Baden, Lindsey R., Jones, Thomas, Donis, Ruben O., Koup, Richard A., Gilbert, Peter B., and Follmann, Dean
Published: 2024
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6. Long-term safety and effectiveness of mRNA-1273 vaccine in adults: COVE trial open-label and booster phases

Author: Baden, Lindsey R., El Sahly, Hana M., Essink, Brandon, Follmann, Dean, Hachigian, Gregory, Strout, Cynthia, Overcash, J. Scott, Doblecki-Lewis, Susanne, Whitaker, Jennifer A., Anderson, Evan J., Neuzil, Kathleen, Corey, Lawrence, Priddy, Frances, Tomassini, Joanne E., Brown, Mollie, Girard, Bethany, Stolman, Dina, Urdaneta, Veronica, Wang, Xiaowei, Deng, Weiping, Zhou, Honghong, Dixit, Avika, Das, Rituparna, and Miller, Jacqueline M.
Published: 2024
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7. Author Correction: High monoclonal neutralization titers reduced breakthrough HIV-1 viral loads in the Antibody Mediated Prevention trials

Author: Reeves, Daniel B., Mayer, Bryan T., deCamp, Allan C., Huang, Yunda, Zhang, Bo, Carpp, Lindsay N., Magaret, Craig A., Juraska, Michal, Gilbert, Peter B., Montefiori, David C., Bar, Katharine J., Cardozo-Ojeda, E. Fabian, Schiffer, Joshua T., Rossenkhan, Raabya, Edlefsen, Paul, Morris, Lynn, Mkhize, Nonhlanhla N., Williamson, Carolyn, Mullins, James I., Seaton, Kelly E., Tomaras, Georgia D., Andrew, Philip, Mgodi, Nyaradzo, Ledgerwood, Julie E., Cohen, Myron S., Corey, Lawrence, Naidoo, Logashvari, Orrell, Catherine, Goepfert, Paul A., Casapia, Martin, Sobieszczyk, Magdalena E., Karuna, Shelly T., and Edupuganti, Srilatha
Published: 2024
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8. Pharmacokinetic serum concentrations of VRC01 correlate with prevention of HIV-1 acquisition

Author: Seaton, Kelly E, Huang, Yunda, Karuna, Shelly, Heptinstall, Jack R, Brackett, Caroline, Chiong, Kelvin, Zhang, Lily, Yates, Nicole L, Sampson, Mark, Rudnicki, Erika, Juraska, Michal, deCamp, Allan C, Edlefsen, Paul T, Mullins, James I, Williamson, Carolyn, Rossenkhan, Raabya, Giorgi, Elena E, Kenny, Avi, Angier, Heather, Randhawa, April, Weiner, Joshua A, Rojas, Michelle, Sarzotti-Kelsoe, Marcella, Zhang, Lu, Sawant, Sheetal, Ackerman, Margaret E, McDermott, Adrian B, Mascola, John R, Hural, John, McElrath, M Julianna, Andrew, Philip, Hidalgo, Jose A, Clark, Jesse, Laher, Fatima, Orrell, Catherine, Frank, Ian, Gonzales, Pedro, Edupuganti, Srilatha, Mgodi, Nyaradzo, Corey, Lawrence, Morris, Lynn, Montefiori, David, Cohen, Myron S, Gilbert, Peter B, and Tomaras, Georgia D
Subjects: Biomedical and Clinical Sciences, Immunology, Infectious Diseases, Clinical Research, Vaccine Related, Clinical Trials and Supportive Activities, Vaccine Related (AIDS), Pediatric, Sexually Transmitted Infections, Prevention, HIV/AIDS, Biotechnology, Immunization, Pediatric AIDS, 6.1 Pharmaceuticals, Good Health and Well Being, Humans, Broadly Neutralizing Antibodies, Antibodies, Neutralizing, Acquired Immunodeficiency Syndrome, HIV Infections, HIV Seropositivity, HIV Antibodies, HIV-1, AIDS Vaccines, Body weight-based dosing, HIV, Broadly neutralising antibodies, body weight, prevention, broadly neutralizing antibodies, monoclonal antibody, pharmacokinetics, Clinical Sciences, Public Health and Health Services, Clinical sciences, Epidemiology
Abstract: BackgroundThe phase 2b proof-of-concept Antibody Mediated Prevention (AMP) trials showed that VRC01, an anti-HIV-1 broadly neutralising antibody (bnAb), prevented acquisition of HIV-1 sensitive to VRC01. To inform future study design and dosing regimen selection of candidate bnAbs, we investigated the association of VRC01 serum concentration with HIV-1 acquisition using AMP trial data.MethodsThe case-control sample included 107 VRC01 recipients who acquired HIV-1 and 82 VRC01 recipients who remained without HIV-1 during the study. We measured VRC01 serum concentrations with a qualified pharmacokinetic (PK) Binding Antibody Multiplex Assay. We employed nonlinear mixed effects PK modelling to estimate daily-grid VRC01 concentrations. Cox regression models were used to assess the association of VRC01 concentration at exposure and baseline body weight, with the hazard of HIV-1 acquisition and prevention efficacy as a function of VRC01 concentration. We also compared fixed dosing vs. body weight-based dosing via simulations.FindingsEstimated VRC01 concentrations in VRC01 recipients without HIV-1 were higher than those in VRC01 recipients who acquired HIV-1. Body weight was inversely associated with HIV-1 acquisition among both placebo and VRC01 recipients but did not modify the prevention efficacy of VRC01. VRC01 concentration was inversely correlated with HIV-1 acquisition, and positively correlated with prevention efficacy of VRC01. Simulation studies suggest that fixed dosing may be comparable to weight-based dosing in overall predicted prevention efficacy.InterpretationThese findings suggest that bnAb serum concentration may be a useful marker for dosing regimen selection, and operationally efficient fixed dosing regimens could be considered for future trials of HIV-1 bnAbs.FundingWas provided by the National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIAID) (UM1 AI068614, to the HIV Vaccine Trials Network [HVTN]; UM1 AI068635, to the HVTN Statistical Data and Management Center [SDMC], Fred Hutchinson Cancer Center [FHCC]; 2R37 054165 to the FHCC; UM1 AI068618, to HVTN Laboratory Center, FHCC; UM1 AI068619, to the HPTN Leadership and Operations Center; UM1 AI068613, to the HIV Prevention Trials Network [HPTN] Laboratory Center; UM1 AI068617, to the HPTN SDMC; and P30 AI027757, to the Center for AIDS Research, Duke University (AI P30 AI064518) and University of Washington (P30 AI027757) Centers for AIDS Research; R37AI054165 from NIAID to the FHCC; and OPP1032144 CA-VIMC Bill & Melinda Gates Foundation.
Published: 2023

9. Modifiers of COVID-19 vaccine efficacy: Results from four COVID-19 prevention network efficacy trials.

Author: Turley, Christine B, Tables, LaKesha, Fuller, Trevon, Sanders, Lisa J, Scott, Hyman, Moodley, Amaran, Woodward Davis, Amanda, Leav, Brett, Miller, Jacqueline, Schoemaker, Kathryn, Vandebosch, An, Sadoff, Jerald, Woo, Wayne, Cho, Iksung, Dunkle, Lisa M, Li, Sijia, van der Laan, Lars, Gilbert, Peter B, Follmann, Dean, Jaynes, Holly, Kublin, James G, Baden, Lindsey R, Goepfert, Paul, Kotloff, Karen, Gay, Cynthia L, Falsey, Ann R, El Sahly, Hana M, Sobieszczyk, Magdalena E, Huang, Yunda, Neuzil, Kathleen M, Corey, Lawrence, Grinsztejn, Beatriz, Gray, Glenda, Rouphael, Nadine, Luedtke, Alex, and COVID-19 Prevention Network CoVPN
Subjects: COVID-19 Prevention Network CoVPN, Humans, Adult, COVID-19, COVID-19 Vaccines, 2019-nCoV Vaccine mRNA-1273, Ad26COVS1, ChAdOx1 nCoV-19, Comorbidity, Effect modifier, Environmental exposure, Epidemiologic, Occupational exposure, SARS-CoV-2, Vaccine efficacy, Clinical Research, Prevention, Clinical Trials and Supportive Activities, Infectious Diseases, Vaccine Related, Immunization, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Prevention of disease and conditions, and promotion of well-being, 3.4 Vaccines, Infection, Good Health and Well Being, Biological Sciences, Agricultural and Veterinary Sciences, Medical and Health Sciences, Virology
Abstract: Questions remain regarding the effect of baseline host and exposure factors on vaccine efficacy (VE) across pathogens and vaccine platforms. We report placebo-controlled data from four Phase 3 COVID-19 trials during the early period of the pandemic. This was a cross-protocol analysis of four randomized, placebo-controlled efficacy trials (Moderna/mRNA1273, AstraZeneca/AZD1222, Janssen/Ad26.COV2.S, and Novavax/NVX-CoV2373) using a harmonized design. Trials were conducted in the United States and international sites in adults ≥ 18 years of age. VE was assessed for symptomatic and severe COVID-19. We analyzed 114,480 participants from both placebo and vaccine arms, enrolled July 2020 to February 2021, with follow up through July 2021. VE against symptomatic COVID-19 showed little heterogeneity across baseline socio-demographic, clinical or exposure characteristics, in either univariate or multivariate analysis, regardless of vaccine platform. Similarly, VE against severe COVID-19 in the single trial (Janssen) with sufficient endpoints for analysis showed little evidence of heterogeneity. COVID-19 VE is not influenced by baseline host or exposure characteristics across efficacy trials of different vaccine platforms and countries when well matched to circulating virus strains. This supports use of these vaccines, regardless of platform type, as effective tools in the near term for reducing symptomatic and severe COVID-19, particularly for older individuals and those with common co-morbidities during major variant shifts. Clinical trial registration numbers: NCT04470427, NCT04516746, NCT04505722, and NCT04611802.
Published: 2023

10. Stochastic Interventional Vaccine Efficacy and Principal Surrogate Analyses of Antibody Markers as Correlates of Protection against Symptomatic COVID-19 in the COVE mRNA-1273 Trial

Author: Huang, Ying, Hejazi, Nima S, Blette, Bryan, Carpp, Lindsay N, Benkeser, David, Montefiori, David C, McDermott, Adrian B, Fong, Youyi, Janes, Holly E, Deng, Weiping, Zhou, Honghong, Houchens, Christopher R, Martins, Karen, Jayashankar, Lakshmi, Flach, Britta, Lin, Bob C, O’Connell, Sarah, McDanal, Charlene, Eaton, Amanda, Sarzotti-Kelsoe, Marcella, Lu, Yiwen, Yu, Chenchen, Kenny, Avi, Carone, Marco, Huynh, Chuong, Miller, Jacqueline, Sahly, Hana M El, Baden, Lindsey R, Jackson, Lisa A, Campbell, Thomas B, Clark, Jesse, Andrasik, Michele P, Kublin, James G, Corey, Lawrence, Neuzil, Kathleen M, Pajon, Rolando, Follmann, Dean, Donis, Ruben O, Koup, Richard A, Gilbert, Peter B, Assays, on behalf of the Immune, Moderna, Inc, Efficacy, Coronavirus Vaccine Prevention Network Coronavirus, and Teams, Government CoVPN Biostatistics
Subjects: Microbiology, Biological Sciences, Coronaviruses, Biotechnology, Infectious Diseases, Immunization, Vaccine Related, Emerging Infectious Diseases, Good Health and Well Being, Humans, 2019-nCoV Vaccine mRNA-1273, Antibodies, Neutralizing, Antibodies, Viral, COVID-19, Immunoglobulin G, Vaccine Efficacy, binding antibody assay, immune correlates of protection, modified treatment policy, neutralizing antibody assay, principal stratification, principal surrogate, SARS-CoV-2, stochastic intervention, stochastic interventional vaccine efficacy
Abstract: The COVE trial randomized participants to receive two doses of mRNA-1273 vaccine or placebo on Days 1 and 29 (D1, D29). Anti-SARS-CoV-2 Spike IgG binding antibodies (bAbs), anti-receptor binding domain IgG bAbs, 50% inhibitory dilution neutralizing antibody (nAb) titers, and 80% inhibitory dilution nAb titers were measured at D29 and D57. We assessed these markers as correlates of protection (CoPs) against COVID-19 using stochastic interventional vaccine efficacy (SVE) analysis and principal surrogate (PS) analysis, frameworks not used in our previous COVE immune correlates analyses. By SVE analysis, hypothetical shifts of the D57 Spike IgG distribution from a geometric mean concentration (GMC) of 2737 binding antibody units (BAU)/mL (estimated vaccine efficacy (VE): 92.9% (95% CI: 91.7%, 93.9%)) to 274 BAU/mL or to 27,368 BAU/mL resulted in an overall estimated VE of 84.2% (79.0%, 88.1%) and 97.6% (97.4%, 97.7%), respectively. By binary marker PS analysis of Low and High subgroups (cut-point: 2094 BAU/mL), the ignorance interval (IGI) and estimated uncertainty interval (EUI) for VE were [85%, 90%] and (78%, 93%) for Low compared to [95%, 96%] and (92%, 97%) for High. By continuous marker PS analysis, the IGI and 95% EUI for VE at the 2.5th percentile (519.4 BAU/mL) vs. at the 97.5th percentile (9262.9 BAU/mL) of D57 Spike IgG concentration were [92.6%, 93.4%] and (89.2%, 95.7%) vs. [94.3%, 94.6%] and (89.7%, 97.0%). Results were similar for other D29 and D57 markers. Thus, the SVE and PS analyses additionally support all four markers at both time points as CoPs.
Published: 2023

11. 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

12. 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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13. 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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14. High Asymptomatic Carriage With the Omicron Variant in South Africa

Author: Garrett, Nigel, Tapley, Asa, Andriesen, Jessica, Seocharan, Ishen, Fisher, Leigh H, Bunts, Lisa, Espy, Nicole, Wallis, Carole L, Randhawa, April Kaur, Miner, Maurine D, Ketter, Nzeera, Yacovone, Margaret, Goga, Ameena, Huang, Yunda, Hural, John, Kotze, Philip, Bekker, Linda Gail, Gray, Glenda E, Corey, Lawrence, Ahmed, Khatija, Badal-Faesen, Sharlaa, Barnabas, Shaun, Brumskine, William, Comline, Kim, Diacon, Andreas, Dubula, Thozama, Gill, Katherine, Grobbelaar, Coert, Innes, Craig, Kassim, Sheetal, Kotze, Sheena, Lazarus, Erica, Lombaard, Johannes, Luabeya, Angelique, Maboa, Rebone Molobane, Mahoney, Scott, Mahkaza, Disebo, Malahleha, Moelo, Malan, Daniel, Mngadi, Kathryn, Naicker, Nivashnee, Naicker, Vimla, Naidoo, Logashvari, Nchabeleng, Maphoshane, Rassool, Mohammed, Spooner, Elizabeth, Tempelman, Hugo, Mgodi, Nyaradzo, Dadabhai, Sufia, Makhema, Joe, Nuwagaba-Biribonwoha, Harriet, Samandari, Taraz, Elyanu, Peter James, Chilengi, Roma, Chirenje, Zvavahera, McElrath, Julie, Cohen, Myron, Kublin, James, Gilbert, Peter, Peda, Melissa, Andersen-Nissen, Erica, Ferrari, Guido, Villaran, Manuel, Takalani, Azwidhwi, Gildea, Marianne, Nebergall, Michelle, Sopher, Carrie, Proulx-Burns, Lori, Govender, Dhevium, Sanders, Lisa, Hanke, Jen, Baepanye, Kagisho, Le Roux, Bert, Wilvich, Haven, Sripathy, Smitha, Margineantu, Daciana, Brown, Valerie, Linton, Kim, Howell, Haley, Noronha, Bianca, Nikles, Sarah, Toledano, Alicia, May, Jeanine, El-Khorazaty, Jill, Naidoo, Keshani, Khuto, Kentse, Mayat, Fatima, Fairall, Lara, and Sanne, Ian
Subjects: Medical Microbiology, Biomedical and Clinical Sciences, Pneumonia & Influenza, Infectious Diseases, Vaccine Related, Lung, Prevention, Emerging Infectious Diseases, Clinical Research, Pneumonia, Biodefense, Clinical Trials and Supportive Activities, Infection, Good Health and Well Being, COVID-19, Humans, Polymerase Chain Reaction, SARS-CoV-2, South Africa, Omicron variant, asymptomatic carriage, PWH, Ubuntu Study Team, Biological Sciences, Medical and Health Sciences, Microbiology, Clinical sciences
Abstract: We report a 23% asymptomatic severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) Omicron carriage rate in participants being enrolled into a clinical trial in South Africa, 15-fold higher than in trials before Omicron. We also found lower CD4 + T-cell counts in persons with human immunodeficiency virus (HIV) strongly correlated with increased odds of being SARS-CoV-2 polymerase chain reaction (PCR) positive.
Published: 2022

15. Vaccine induction of heterologous HIV-1-neutralizing antibody B cell lineages in humans

Author: Williams, Wilton B., Alam, S. Munir, Ofek, Gilad, Erdmann, Nathaniel, Montefiori, David C., Seaman, Michael S., Wagh, Kshitij, Korber, Bette, Edwards, Robert J., Mansouri, Katayoun, Eaton, Amanda, Cain, Derek W., Martin, Mitchell, Hwang, JongIn, Arus-Altuz, Aria, Lu, Xiaozhi, Cai, Fangping, Jamieson, Nolan, Parks, Robert, Barr, Maggie, Foulger, Andrew, Anasti, Kara, Patel, Parth, Sammour, Salam, Parsons, Ruth J., Huang, Xiao, Lindenberger, Jared, Fetics, Susan, Janowska, Katarzyna, Niyongabo, Aurelie, Janus, Benjamin M., Astavans, Anagh, Fox, Christopher B., Mohanty, Ipsita, Evangelous, Tyler, Chen, Yue, Berry, Madison, Kirshner, Helene, Van Itallie, Elizabeth, Saunders, Kevin O., Wiehe, Kevin, Cohen, Kristen W., McElrath, M. Juliana, Corey, Lawrence, Acharya, Priyamvada, Walsh, Stephen R., Baden, Lindsey R., and Haynes, Barton F.
Published: 2024
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16. High monoclonal neutralization titers reduced breakthrough HIV-1 viral loads in the Antibody Mediated Prevention trials

Author: Reeves, Daniel B., Mayer, Bryan T., deCamp, Allan C., Huang, Yunda, Zhang, Bo, Carpp, Lindsay N., Magaret, Craig A., Juraska, Michal, Gilbert, Peter B., Montefiori, David C., Bar, Katharine J., Cardozo-Ojeda, E. Fabian, Schiffer, Joshua T., Rossenkhan, Raabya, Edlefsen, Paul, Morris, Lynn, Mkhize, Nonhlanhla N., Williamson, Carolyn, Mullins, James I., Seaton, Kelly E., Tomaras, Georgia D., Andrew, Philip, Mgodi, Nyaradzo, Ledgerwood, Julie E., Cohen, Myron S., Corey, Lawrence, Naidoo, Logashvari, Orrell, Catherine, Goepfert, Paul A., Casapia, Martin, Sobieszczyk, Magdalena E., Karuna, Shelly T., and Edupuganti, Srilatha
Published: 2023
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17. Adults on pre-exposure prophylaxis (tenofovir-emtricitabine) have faster clearance of anti-HIV monoclonal antibody VRC01

Author: Huang, Yunda, Zhang, Lily, Karuna, Shelly, Andrew, Philip, Juraska, Michal, Weiner, Joshua A., Angier, Heather, Morgan, Evgenii, Azzam, Yasmin, Swann, Edith, Edupuganti, Srilatha, Mgodi, Nyaradzo M., Ackerman, Margaret E., Donnell, Deborah, Gama, Lucio, Anderson, Peter L., Koup, Richard A., Hural, John, Cohen, Myron S., Corey, Lawrence, McElrath, M. Juliana, Gilbert, Peter B., and Lemos, Maria P.
Published: 2023
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18. Publisher Correction: Immune correlates analysis of the PREVENT-19 COVID-19 vaccine efficacy clinical trial

Author: Fong, Youyi, Huang, Yunda, Benkeser, David, Carpp, Lindsay N., Áñez, Germán, Woo, Wayne, McGarry, Alice, Dunkle, Lisa M., Cho, Iksung, Houchens, Christopher R., Martins, Karen, Jayashankar, Lakshmi, Castellino, Flora, Petropoulos, Christos J., Leith, Andrew, Haugaard, Deanne, Webb, Bill, Lu, Yiwen, Yu, Chenchen, Borate, Bhavesh, van der Laan, Lars W. P., Hejazi, Nima S., Randhawa, April K., Andrasik, Michele P., Kublin, James G., Hutter, Julia, Keshtkar-Jahromi, Maryam, Beresnev, Tatiana H., Corey, Lawrence, Neuzil, Kathleen M., Follmann, Dean, Ake, Julie A., Gay, Cynthia L., Kotloff, Karen L., Koup, Richard A., Donis, Ruben O., and Gilbert, Peter B.
Published: 2023
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19. Immune correlates analysis of the PREVENT-19 COVID-19 vaccine efficacy clinical trial

Author: Fong, Youyi, Huang, Yunda, Benkeser, David, Carpp, Lindsay N., Áñez, Germán, Woo, Wayne, McGarry, Alice, Dunkle, Lisa M., Cho, Iksung, Houchens, Christopher R., Martins, Karen, Jayashankar, Lakshmi, Castellino, Flora, Petropoulos, Christos J., Leith, Andrew, Haugaard, Deanne, Webb, Bill, Lu, Yiwen, Yu, Chenchen, Borate, Bhavesh, van der Laan, Lars W. P., Hejazi, Nima S., Randhawa, April K., Andrasik, Michele P., Kublin, James G., Hutter, Julia, Keshtkar-Jahromi, Maryam, Beresnev, Tatiana H., Corey, Lawrence, Neuzil, Kathleen M., Follmann, Dean, Ake, Julie A., Gay, Cynthia L., Kotloff, Karen L., Koup, Richard A., Donis, Ruben O., and Gilbert, Peter B.
Published: 2023
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20. Immune correlates analysis of a phase 3 trial of the AZD1222 (ChAdOx1 nCoV-19) vaccine

Author: Benkeser, David, Fong, Youyi, Janes, Holly E., Kelly, Elizabeth J., Hirsch, Ian, Sproule, Stephanie, Stanley, Ann Marie, Maaske, Jill, Villafana, Tonya, Houchens, Christopher R., Martins, Karen, Jayashankar, Lakshmi, Castellino, Flora, Ayala, Victor, Petropoulos, Christos J., Leith, Andrew, Haugaard, Deanne, Webb, Bill, Lu, Yiwen, Yu, Chenchen, Borate, Bhavesh, van der Laan, Lars W. P., Hejazi, Nima S., Carpp, Lindsay N., Randhawa, April K., Andrasik, Michele P., Kublin, James G., Isaacs, Margaret Brewinski, Makhene, Mamodikoe, Tong, Tina, Robb, Merlin L., Corey, Lawrence, Neuzil, Kathleen M., Follmann, Dean, Hoffman, Corey, Falsey, Ann R., Sobieszczyk, Magdalena, Koup, Richard A., Donis, Ruben O., and Gilbert, Peter B.
Published: 2023
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21. The potential of broadly neutralizing antibodies for HIV prevention

Author: Gelderblom, Huub C., Corey, Lawrence, and Barouch, Dan H.
Subjects: HIV (Viruses) -- Prevention, Viral antibodies, Sexually transmitted diseases -- Prevention, Antibodies, Health
Abstract: The number of new HIV acquisitions globally has declined, but not rapidly enough to meet the 2030 targets set by UNAIDS and the United Nations Sustainable Development Goals (SDGs) [1, [...]
Published: 2024
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22. Anti-PD-1 chimeric antigen receptor T cells efficiently target SIV-infected [CD4.sup.+] T cells in germinal centers

Author: Eichholz, Karsten, Fukazawa, Yoshinori, Peterson, Christopher W., Haeseleer, Francoise, Medina, Manuel, Hoffmeister, Shelby, Duell, Derick M., Varco-Merth, Benjamin D., Dross, Sandra, Park, Haesun, Labriola, Caralyn S., Axthelm, Michael K., Murnane, Robert D., Smedley, Jeremy V., Jin, Lei, Gong, Jiaxin, Rust, Blake J., Fuller, Deborah H., Kiem, Hans-Peter, Picker, Louis J., Okoye, Afam A., and Corey, Lawrence
Subjects: T cells, Antiviral agents, Highly active antiretroviral therapy, Antigens, Apoptosis, Simian immunodeficiency virus -- Development and progression, Virus diseases -- Development and progression, Health care industry
Abstract: Programmed cell death protein 1 (PD-1) is an immune checkpoint marker commonly expressed on memory T cells and enriched in latently HIV-infected [CD4.sup.+] T cells. We engineered an anti-PD-1 chimeric antigen receptor (CAR) to assess the impact of PD-1 depletion on viral reservoirs and rebound dynamics in SIVmac239-infected rhesus macaques (RMs). Adoptive transfer of anti-PD-1 CAR T cells was done in 2 SIV-naive and 4 SIV-infected RMs on antiretroviral therapy (ART). In 3 of 6 RMs, anti-PD-1 CAR T cells expanded and persisted for up to 100 days concomitant with the depletion of [PD- 1.sup.+] memory T cells in blood and tissues, including lymph node [CD4.sup.+] follicular helper T (TFH) cells. Loss of TFH cells was associated with depletion of detectable SIV RNA from the germinal center (GC). However, following CAR T infusion and ART interruption, there was a marked increase in SIV replication in extrafollicular portions of lymph nodes, a 2-log higher plasma viremia relative to controls, and accelerated disease progression associated with the depletion of [CD8.sup.+] memory T cells. These data indicate anti-PD-1 CAR T cells depleted [PD-1.sup.+] T cells, including GC TFH cells, and eradicated SIV from this immunological sanctuary., Introduction HIV infects cells of the immune system through interaction with CD4, CCR5, and CXCR4 and establishes long-lasting infections that develop into the acquired immunodeficiency syndrome if left untreated. With [...]
Published: 2024
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23. Safety and immunogenicity of a subtype C ALVAC-HIV (vCP2438) vaccine prime plus bivalent subtype C gp120 vaccine boost adjuvanted with MF59 or alum in healthy adults without HIV (HVTN 107): A phase 1/2a randomized trial

Author: Moodie, Zoe, Andersen-Nissen, Erica, Grunenberg, Nicole, Dintwe, One B., Omar, Faatima Laher, Kee, Jia J., Bekker, Linda-Gail, Laher, Fatima, Naicker, Nivashnee, Jani, Ilesh, Mgodi, Nyaradzo M., Hunidzarira, Portia, Sebe, Modulakgota, Miner, Maurine D., Polakowski, Laura, Ramirez, Shelly, Nebergall, Michelle, Takuva, Simbarashe, Sikhosana, Lerato, Heptinstall, Jack, Seaton, Kelly E., De Rosa, Stephen, Diazgranados, Carlos A., Koutsoukos, Marguerite, Van Der Meeren, Olivier, Barnett, Susan W., Kanesa-thasan, Niranjan, Kublin, James G., Tomaras, Georgia D., McElrath, M. Juliana, Corey, Lawrence, Mngadi, Kathryn, and Goepfert, Paul
Subjects: United States. National Institutes of Health, HIV (Viruses) -- Comparative analysis -- Usage, Vaccination -- Usage -- Comparative analysis, Immune response -- Usage -- Comparative analysis, Immunoglobulin A -- Comparative analysis -- Usage, Clinical trials -- Usage -- Comparative analysis, Adults -- Comparative analysis -- Usage, Immunoglobulin G -- Usage -- Comparative analysis, AIDS vaccines -- Usage -- Product development, Biological sciences
Abstract: Background Adjuvants are widely used to enhance and/or direct vaccine-induced immune responses yet rarely evaluated head-to-head. Our trial directly compared immune responses elicited by MF59 versus alum adjuvants in the RV144-like HIV vaccine regimen modified for the Southern African region. The RV144 trial of a recombinant canarypox vaccine vector expressing HIV env subtype B (ALVAC-HIV) prime followed by ALVAC-HIV plus a bivalent gp120 protein vaccine boost adjuvanted with alum is the only trial to have shown modest HIV vaccine efficacy. Data generated after RV144 suggested that use of MF59 adjuvant might allow lower protein doses to be used while maintaining robust immune responses. We evaluated safety and immunogenicity of an HIV recombinant canarypox vaccine vector expressing HIV env subtype C (ALVAC-HIV) prime followed by ALVAC-HIV plus a bivalent gp120 protein vaccine boost (gp120) adjuvanted with alum (ALVAC-HIV+gp120/alum) or MF59 (ALVAC-HIV+gp120/MF59) or unadjuvanted (ALVAC-HIV+gp120/no-adjuvant) and a regimen where ALVAC-HIV+gp120 adjuvanted with MF59 was used for the prime and boost (ALVAC-HIV+gp120/MF59 coadministration). Methods and findings Between June 19, 2017 and June 14, 2018, 132 healthy adults without HIV in South Africa, Zimbabwe, and Mozambique were randomized to receive intramuscularly: (1) 2 priming doses of ALVAC-HIV (months 0 and 1) followed by 3 booster doses of ALVAC-HIV+gp120/MF59 (months 3, 6, and 12), n = 36; (2) 2 priming doses of ALVAC-HIV (months 0 and 1) followed by 3 booster doses of ALVAC-HIV+gp120/alum (months 3, 6, and 12), n = 36; (3) 4 doses of ALVAC-HIV+gp120/MF59 coadministered (months 0, 1, 6, and 12), n = 36; or (4) 2 priming doses of ALVAC-HIV (months 0 and 1) followed by 3 booster doses of ALVAC-HIV+gp120/no adjuvant (months 3, 6, and 12), n = 24. Primary outcomes were safety and occurrence and mean fluorescence intensity (MFI) of vaccine-induced gp120-specific IgG and IgA binding antibodies at month 6.5. All vaccinations were safe and well-tolerated; increased alanine aminotransferase was the most frequent related adverse event, occurring in 2 (1.5%) participants (1 severe, 1 mild). At month 6.5, vaccine-specific gp120 IgG binding antibodies were detected in 100% of vaccinees for all 4 vaccine groups. No significant differences were seen in the occurrence and net MFI of vaccine-specific IgA responses between the ALVAC-HIV+gp120/MF59-prime-boost and ALVAC-HIV+gp120/alum-prime-boost groups or between the ALVAC-HIV+gp120/MF59-prime-boost and ALVAC-HIV+gp120/MF59 coadministration groups. Limitations were the relatively small sample size per group and lack of evaluation of higher gp120 doses. Conclusions Although MF59 was expected to enhance immune responses, alum induced similar responses to MF59, suggesting that the choice between these adjuvants may not be critical for the ALVAC+gp120 regimen. Trial registration HVTN 107 was registered with the South African National Clinical Trials Registry (DOH-27-0715-4894) and ClinicalTrials.gov (NCT03284710)., Author(s): Zoe Moodie 1,*, Erica Andersen-Nissen 1,2, Nicole Grunenberg 1, One B. Dintwe 1,2, Faatima Laher Omar 2, Jia J. Kee 1, Linda-Gail Bekker 3, Fatima Laher 4, Nivashnee Naicker [...]
Published: 2024
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24. Safety and immunogenicity of a polyvalent DNA–protein HIV vaccine with matched Env immunogens delivered as a prime–boost regimen or coadministered in HIV-uninfected adults in the USA (HVTN 124): a phase 1, placebo-controlled, double-blind randomised controlled trial

Author: Frank, Ian, Li, Shuying S, Grunenberg, Nicole, Overton, Edgar T, Robinson, Samuel T, Zheng, Hua, Seaton, Kelly E, Heptinstall, Jack R, Allen, Mary A, Mayer, Kenneth H, Culver, Daniel A, Keefer, Michael C, Edupuganti, Sri, Pensiero, Michael N, Mehra, Vijay L, De Rosa, Stephen C, Morris, Daryl E, Wang, Shixia, Seaman, Michael S, Montefiori, David C, Ferrari, Guido, Tomaras, Georgia D, Kublin, James G, Corey, Lawrence, and Lu, Shan
Published: 2024
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25. Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico

Author: Dunkle, Lisa M, Kotloff, Karen L, Gay, Cynthia L, Áñez, Germán, Adelglass, Jeffrey M, Barrat Hernández, Alejandro Q, Harper, Wayne L, Duncanson, Daniel M, McArthur, Monica A, Florescu, Diana F, McClelland, R Scott, Garcia-Fragoso, Veronica, Riesenberg, Robert A, Musante, David B, Fried, David L, Safirstein, Beth E, McKenzie, Mark, Jeanfreau, Robert J, Kingsley, Jeffrey K, Henderson, Jeffrey A, Lane, Dakotah C, Ruíz-Palacios, Guillermo M, Corey, Lawrence, Neuzil, Kathleen M, Coombs, Robert W, Greninger, Alex L, Hutter, Julia, Ake, Julie A, Smith, Katherine, Woo, Wayne, Cho, Iksung, Glenn, Gregory M, and Dubovsky, Filip
Subjects: Biomedical and Clinical Sciences, Clinical Sciences, Emerging Infectious Diseases, Clinical Trials and Supportive Activities, Immunization, Vaccine Related, Genetics, Prevention, Infectious Diseases, Clinical Research, Lung, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Infection, Good Health and Well Being, Adolescent, Adult, Aged, COVID-19, COVID-19 Nucleic Acid Testing, COVID-19 Vaccines, Humans, Incidence, Male, Mexico, Middle Aged, SARS-CoV-2, Single-Blind Method, United States, Vaccine Efficacy, 2019nCoV-301 Study Group, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract: BackgroundNVX-CoV2373 is an adjuvanted, recombinant spike protein nanoparticle vaccine that was shown to have clinical efficacy for the prevention of coronavirus disease 2019 (Covid-19) in phase 2b-3 trials in the United Kingdom and South Africa, but its efficacy had not yet been tested in North America.MethodsWe conducted a phase 3, randomized, observer-blinded, placebo-controlled trial in the United States and Mexico during the first half of 2021 to evaluate the efficacy and safety of NVX-CoV2373 in adults (≥18 years of age) who had not had severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Participants were randomly assigned in a 2:1 ratio to receive two doses of NVX-CoV2373 or placebo 21 days apart. The primary objective was to determine vaccine efficacy against reverse-transcriptase-polymerase-chain-reaction-confirmed Covid-19 occurring at least 7 days after the second dose. Vaccine efficacy against moderate-to-severe disease and against different variants was also assessed.ResultsOf the 29,949 participants who underwent randomization between December 27, 2020, and February 18, 2021, a total of 29,582 (median age, 47 years; 12.6% ≥65 years of age) received at least one dose: 19,714 received vaccine and 9868 placebo. Over a period of 3 months, 77 cases of Covid-19 were noted - 14 among vaccine recipients and 63 among placebo recipients (vaccine efficacy, 90.4%; 95% confidence interval [CI], 82.9 to 94.6; P
Published: 2022

26. KSHV (HHV8) vaccine: promises and potential pitfalls for a new anti-cancer vaccine

Author: Casper, Corey, Corey, Lawrence, Cohen, Jeffrey I, Damania, Blossom, Gershon, Anne A, Kaslow, David C, Krug, Laurie T, Martin, Jeffrey, Mbulaiteye, Sam M, Mocarski, Edward S, Moore, Patrick S, Ogembo, Javier Gordon, Phipps, Warren, Whitby, Denise, and Wood, Charles
Subjects: Biomedical and Clinical Sciences, Immunology, Cancer, Orphan Drug, Vaccine Related, Rare Diseases, Infectious Diseases, Biotechnology, Immunization, Emerging Infectious Diseases, Prevention, HIV/AIDS, 3.4 Vaccines, Prevention of disease and conditions, and promotion of well-being, Infection, Good Health and Well Being, Medical microbiology
Abstract: Seven viruses cause at least 15% of the total cancer burden. Viral cancers have been described as the "low-hanging fruit" that can be potentially prevented or treated by new vaccines that would alter the course of global human cancer. Kaposi sarcoma herpesvirus (KSHV or HHV8) is the sole cause of Kaposi sarcoma, which primarily afflicts resource-poor and socially marginalized populations. This review summarizes a recent NIH-sponsored workshop's findings on the epidemiology and biology of KSHV as an overlooked but potentially vaccine-preventable infection. The unique epidemiology of this virus provides opportunities to prevent its cancers if an effective, inexpensive, and well-tolerated vaccine can be developed and delivered.
Published: 2022

27. 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

28. Efficacy of the mRNA-1273 SARS-CoV-2 Vaccine at Completion of Blinded Phase

Author: El Sahly, Hana M, Baden, Lindsey R, Essink, Brandon, Doblecki-Lewis, Susanne, Martin, Judith M, Anderson, Evan J, Campbell, Thomas B, Clark, Jesse, Jackson, Lisa A, Fichtenbaum, Carl J, Zervos, Marcus, Rankin, Bruce, Eder, Frank, Feldman, Gregory, Kennelly, Christina, Han-Conrad, Laurie, Levin, Michael, Neuzil, Kathleen M, Corey, Lawrence, Gilbert, Peter, Janes, Holly, Follmann, Dean, Marovich, Mary, Polakowski, Laura, Mascola, John R, Ledgerwood, Julie E, Graham, Barney S, August, Allison, Clouting, Heather, Deng, Weiping, Han, Shu, Leav, Brett, Manzo, Deb, Pajon, Rolando, Schödel, Florian, Tomassini, Joanne E, Zhou, Honghong, and Miller, Jacqueline
Subjects: Biomedical and Clinical Sciences, Clinical Sciences, Clinical Trials and Supportive Activities, Infectious Diseases, Emerging Infectious Diseases, Clinical Research, Genetics, Vaccine Related, Prevention, Lung, Immunization, Biodefense, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Infection, Good Health and Well Being, 2019-nCoV Vaccine mRNA-1273, Adolescent, Adult, Aged, COVID-19, COVID-19 Vaccines, Follow-Up Studies, Humans, Immunization, Secondary, Immunogenicity, Vaccine, Incidence, Intention to Treat Analysis, Male, Middle Aged, Patient Acuity, Single-Blind Method, Treatment Outcome, Young Adult, COVE Study Group, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract: BackgroundAt interim analysis in a phase 3, observer-blinded, placebo-controlled clinical trial, the mRNA-1273 vaccine showed 94.1% efficacy in preventing coronavirus disease 2019 (Covid-19). After emergency use of the vaccine was authorized, the protocol was amended to include an open-label phase. Final analyses of efficacy and safety data from the blinded phase of the trial are reported.MethodsWe enrolled volunteers who were at high risk for Covid-19 or its complications; participants were randomly assigned in a 1:1 ratio to receive two intramuscular injections of mRNA-1273 (100 μg) or placebo, 28 days apart, at 99 centers across the United States. The primary end point was prevention of Covid-19 illness with onset at least 14 days after the second injection in participants who had not previously been infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The data cutoff date was March 26, 2021.ResultsThe trial enrolled 30,415 participants; 15,209 were assigned to receive the mRNA-1273 vaccine, and 15,206 to receive placebo. More than 96% of participants received both injections, 2.3% had evidence of SARS-CoV-2 infection at baseline, and the median follow-up was 5.3 months in the blinded phase. Vaccine efficacy in preventing Covid-19 illness was 93.2% (95% confidence interval [CI], 91.0 to 94.8), with 55 confirmed cases in the mRNA-1273 group (9.6 per 1000 person-years; 95% CI, 7.2 to 12.5) and 744 in the placebo group (136.6 per 1000 person-years; 95% CI, 127.0 to 146.8). The efficacy in preventing severe disease was 98.2% (95% CI, 92.8 to 99.6), with 2 cases in the mRNA-1273 group and 106 in the placebo group, and the efficacy in preventing asymptomatic infection starting 14 days after the second injection was 63.0% (95% CI, 56.6 to 68.5), with 214 cases in the mRNA-1273 group and 498 in the placebo group. Vaccine efficacy was consistent across ethnic and racial groups, age groups, and participants with coexisting conditions. No safety concerns were identified.ConclusionsThe mRNA-1273 vaccine continued to be efficacious in preventing Covid-19 illness and severe disease at more than 5 months, with an acceptable safety profile, and protection against asymptomatic infection was observed. (Funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases; COVE ClinicalTrials.gov number, NCT04470427.).
Published: 2021

29. Polytopic fractional delivery of an HIV vaccine alters cellular responses and results in increased epitope breadth in a phase 1 randomized trial

Author: Kalichman, Artur, Edlefsen, Paul, Enama, Mary, Hural, John, Holt, Renee, Dunbar, Debora, Crawford, Dave, Maki, Ian, Johannessen, Jan, Estep, Scharla, Grigoriev, Yevgeny, Madenwald, Tamra, Hansen, Marianne, Holman, Drienna, Fair, Ramey, Meyer, Genevieve, Luke-Kilolam, Anya, Miner, Maurine D., deCamp, Allan, Grunenberg, Nicole, De Rosa, Stephen C., Fiore-Gartland, Andrew, Bar, Katherine, Spearman, Paul, Allen, Mary, Yu, Pei-Chun, Manso, Bryce, Frahm, Nicole, Kalams, Spyros, Baden, Lindsey, Keefer, Michael C., Scott, Hyman M., Novak, Richard, Van Tieu, Hong, Tomaras, Georgia D., Kublin, James G., McElrath, M. Juliana, Corey, Lawrence, and Frank, Ian
Published: 2024
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30. RRScell method for automated single-cell profiling of multiplexed immunofluorescence cancer tissue

Author: Li, Alvason Zhenhua, Eichholz, Karsten, Sholukh, Anton, Stone, Daniel, Loprieno, Michelle A., Jerome, Keith R., Phasouk, Khamsone, Diem, Kurt, Zhu, Jia, and Corey, Lawrence
Subjects: Quantitative Biology - Quantitative Methods, Electrical Engineering and Systems Science - Image and Video Processing, Quantitative Biology - Tissues and Organs, Statistics - Applications
Abstract: Multiplexed immuno-fluorescence tissue imaging, allowing simultaneous detection of molecular properties of cells, is an essential tool for characterizing the complex cellular mechanisms in translational research and clinical practice. New image analysis approaches are needed because tissue section stained with a mixture of protein, DNA and RNA biomarkers are introducing various complexities, including spurious edges due to fluorescent staining artifacts between touching or overlapping cells. We have developed the RRScell method harnessing the stochastic random-reaction-seed (RRS) algorithm and deep neural learning U-net to extract single-cell resolution profiling-map of gene expression over a million cells tissue section accurately and automatically. Furthermore, with the use of manifold learning technique UMAP for cell phenotype cluster analysis, the AI-driven RRScell has equipped with a marker-based image cytometry analysis tool (markerUMAP) in quantifying spatial distribution of cell phenotypes from tissue images with a mixture of biomarkers. The results achieved in this study suggest that RRScell provides a robust enough way for extracting cytometric single cell morphology as well as biomarker content in various tissue types, while the build-in markerUMAP tool secures the efficiency of dimension reduction, making it viable as a general tool in the spatial analysis of high dimensional tissue image., Comment: 8 pages, 6 figures, markerUMAP cell clustering
Published: 2020

31. CD101 genetic variants modify regulatory and conventional T cell phenotypes and functions

Author: Richert-Spuhler, Laura E, Mar, Corinne M, Shinde, Paurvi, Wu, Feinan, Hong, Ting, Greene, Evan, Hou, Sharon, Thomas, Katherine, Gottardo, Raphael, Mugo, Nelly, de Bruyn, Guy, Celum, Connie, Baeten, Jared M, Lingappa, Jairam R, Lund, Jennifer M, Wald, Anna, Campbell, Mary S, Corey, Lawrence, Coombs, Robert W, Hughes, James P, Magaret, Amalia, McElrath, M Juliana, Morrow, Rhoda, Mullins, James I, Coetzee, David, Fife, Kenneth, Were, Edwin, Essex, Max, Makhema, Joseph, Katabira, Elly, Ronald, Allan, Bukusi, Elizabeth, Cohen, Craig, Kapiga, Saidi, Manongi, Rachel, Farquhar, Carey, John-Stewart, Grace, Kiarie, James, Delany-Moretlwe, Sinead, Rees, Helen, Gray, Glenda, McIntyre, James, Mugo, Nelly Rwamba, Donnell, Deborah, Frenkel, Lisa, Hendrix, Craig W, Tumwesigye, Elioda, Ndase, Patrick, Bukusi, Eliabeth, Wangisi, Jonathan, Campbell, James, and Tappero, Jordan
Subjects: Clinical Research, HIV/AIDS, Prevention, Genetics, Infectious Diseases, Aetiology, 2.1 Biological and endogenous factors, 1.1 Normal biological development and functioning, Underpinning research, Inflammatory and immune system, Adult, Antigens, CD, B-Lymphocytes, Cell Lineage, Dendritic Cells, Female, Gene Expression Profiling, Gene Expression Regulation, Genetic Predisposition to Disease, HIV Infections, HIV-1, Humans, Immunity, Innate, Immunophenotyping, Male, Monocytes, Mutation, Phenotype, Receptors, CCR5, Receptors, CXCR4, T-Lymphocytes, Regulatory, Partners in Prevention HSV/HIV Transmission Study, and the Partners PrEP Study Teams, CD101, HIV acquisition, T cell, host genetic variation, immune quiescence, inflammation, inflammatory homeostasis
Abstract: We recently reported that the risk of sexually acquired HIV-1 infection is increased significantly by variants in the gene encoding CD101, a protein thought to modify inflammatory responses. Using blood samples from individuals with and without these variants, we demonstrate that CD101 variants modify the prevalence of circulating inflammatory cell types and show that CD101 variants are associated with increased proinflammatory cytokine production by circulating T cells. One category of CD101 variants is associated with a reduced capacity of regulatory T cells to suppress T cell cytokine production, resulting in a reduction in the baseline level of immune quiescence. These data are supported by transcriptomics data revealing alterations in the intrinsic regulation of antiviral pathways and HIV resistance genes in individuals with CD101 variants. Our data support the hypothesis that CD101 contributes to homeostatic regulation of bystander inflammation, with CD101 variants altering heterosexual HIV-1 acquisition by facilitating increased prevalence and altered function of T cell subsets.
Published: 2021

32. Efficacy of a bivalent (D614 + B.1.351) SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant in adults: a phase 3, parallel, randomised, modified double-blind, placebo-controlled trial

Author: Abalos, Karina, Accini, Jose, Aloysia, Naveena, Amuasi, John Humphrey, Ansah, Nana Akosua, Benkeser, David, Berge, Aude, Beyko, Hanna, Bilotkach, Oleksandra, Breuer, Thomas, Bonfanti, Alberto Cadena, Bukusi, Elisabeth, Canter, Richard, Carrillo, Jaime Augusto, Chansinghakul, Danaya, Coux, Florence, Das, Chandan, Das, Santa Kumar, Devlin, Louis, Espinoza, Luis, Fay, Michael, Follmann, Dean, Frago, Carina, Garinga, Agnes, Gilbert, Peter B, Gonzalez, Claudia, Granados, Maria Angelica, Guillery, Lea, Huang, Ying, Hudzina, Kathy, Jain, Manish, Kanodia, Piush, Khandelwal, Nitin, Mutuluuza, Cissy Kityo, Kiweewa, Francis, Kiwanuka, Noah, Kosolsak, Chalit, Kukian, Darshna, Kushwaha, Jitendra Singh, Laot, Thelma, Lopez-Medina, Eduardo, Macareno Arroyo, Hugo, Mandaliya, Kishorchandra, Mamod, Stephanie, Mangarule, Somnath, Martínez, Javier, McClelland, Scott, Menard, Lisa, Mendoza, Sandra, Mohapatra, Satyajit, Moreau, Catherine, Mugo, Nelly, Nduba, Videlis, Noriega, Fernando, Ntege, Patricia Nahirya, Okech, Brenda, Otero, Maria, Ouma, Samuel Gurrion, Oyieko, Janet, Paredes, Mercedes, Pardo, Erwin, Postol, Svitlana, Pekala, David, Peng, Penny, Py, Marie-Laure, Rivas, Enrique, Rivero, Rafael, Rodriguez, Edith, Saleh, Mansoor, Sánchez, Pedro, Sater, Nessryne, Shah, Jinen, Shrestha, Rajeev, Siika, Abraham, Singh, Chandramani, Singh, Veer Bahadur, Tamrakar, Dipesh, Tavares Da-Silva, Fernanda, Otieno Tina, Lucas, Velasquez, Hector, Wabwire, Deo, Wajja, Anne, Zaworski, Elodie, Zhang, Nianxian, Dayan, Gustavo H, Rouphael, Nadine, Walsh, Stephen R, Chen, Aiying, Grunenberg, Nicole, Allen, Mary, Antony, Johannes, Asante, Kwaku Poku, Bhate, Amit Suresh, Beresnev, Tatiana, Bonaparte, Matthew I, Celle, Médéric, Ceregido, Maria Angeles, Corey, Lawrence, Dobrianskyi, Dmytro, Fu, Bo, Grillet, Marie-Helene, Keshtkar-Jahromi, Maryam, Juraska, Michal, Kee, Jia Jin, Kibuuka, Hannah, Koutsoukos, Marguerite, Masotti, Roger, Michael, Nelson L, Neuzil, Kathleen M, Reynales, Humberto, Robb, Merlin L, Villagómez Martínez, Sandra M, Sawe, Fredrick, Schuerman, Lode, Tong, Tina, Treanor, John, Wartel, T Anh, Diazgranados, Carlos A, Chicz, Roman M, Gurunathan, Sanjay, Savarino, Stephen, and Sridhar, Saranya
Published: 2023
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33. Safety and immunogenicity of a recombinant oligomeric gp145 subtype C Env protein (gp145 C.6980) HIV vaccine candidate in healthy, HIV-1–uninfected adult participants in the US

Author: Tieu, Hong-Van, Karuna, Shelly, Huang, Yunda, Sobieszczyk, Magdalena E., Zheng, Hua, Tomaras, Georgia D., Montefiori, David C., Shen, Mingchao, DeRosa, Stephen, Cohen, Kristen, Isaacs, Margaret Brewinski, Regenold, Stephanie, Heptinstall, Jack, Seaton, Kelly E., Sawant, Sheetal, Furch, Brianna, Pensiero, Michael, Corey, Lawrence, and Bar, Katharine J.
Published: 2023
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34. Risk of COVID-19 after natural infection or vaccination

Author: Adams, Atoya, Miller, Eric, Rankin, Bruce G., Shinn, Steven, Nash, Marshall, Green, Sinikka L., Jacobsen, Colleen, Krishnankutty, Jayasree, Phungwayo, Sikhongi, Glover, Richard M., II, Slechta, Stacy, Holdeman, Troy, Hartvickson, Robyn, Grant, Amber, Poling, Terry L., Klein, Terry D., Klein, Thomas C., Klein, Tracy R., Smith, William B., Gibson, Richard L., Winbigler, Jennifer, Parker, Elizabeth, Wijewardane, Priyantha N., Bravo, Eric, Thessing, Jeffrey, Maxwell, Michelle, Horn, Amanda, Healy, Catherine Mary, Akamine, Christine, Chu, Laurence, Chouteau, R. Michelle, Cotugno, Michael J., Bauer, George H., Jr., Hachigian, Greg, Oshita, Masaru, Cancilla, Michael, Kiersey, Kristen, Seger, William, Antwi, Mohammed, Green, Allison, Kim, Anthony, Desjardins, Michael, Johnson, Jennifer A., Sherman, Amy, Walsh, Stephen R., Borger, Judith, Saleem, Nafisa, Solis, Joel, Medina, Martha Carmen, Keating, Westly, Garcia, Edgar, Bueno, Cynthia, Segall, Nathan, Denham, Douglas S., Weiss, Thomas, Avworo, Ayoade, Hedges, Parke, Strout, Cynthia Becher, Santiago, Rica, Davis, Yvonne, Howenstine, Patty, Bondell, Alison, Marks, Kristin, Wang, Tina, Wilkin, Timothy, Vogler, Mary, Johnston, Carrie, Andrasik, Michele P., Andriesen, Jessica G., Broder, Gail, Eaton, Niles, Gelderblom, Huub G., McClennen, Rachael, Michael, Nelson, Robb, Merlin, Sopher, Carrie, Miller, Vicki E., Santiago, Fredric, Gomez, Blanca, Valika, Insiya, Starr, Amy, Cantos, Valeria D., Kandiah, Sheetal, Rio, Carlos del, Rouphael, Nadine, Edupuganti, Srilatha, Anderson, Evan J., Camacho-Gonzalez, Andres, Kamidani, Satoshi, Teherani, Meghan, Diemert, David J., Malkin, Elissa, Siegel, Marc, Roberts, Afsoon, Simon, Gary, Balani, Bindu, Stephenson, Carolene, Sperber, Steven, Cicogna, Cristina, Zervos, Marcus J., Kilgore, Paul, Ramesh, Mayur, Herc, Erica, Zenlea, Kate, Burgher, Abram, Milliken, Ann M., Davis, Joseph D., Levy, Brendan, Kelman, Sandra, Doust, Matthew W., Sample, Denise, Erickson, Sandra, Christensen, Shane G., Matich, Christopher, Longe, James, Witbeck, John, Peterson, James T., Clark, Alexander, Kelty, Gerald, Pena-Renteria, Issac, Koren, Michael J., Bartilucci, Darlene, Patel, Alpa, Tran, Carolyn, Kennelly, Christina, Brownlee, Robert, Coleman, Jacob, Webster, Hala, Fierro, Carlos A., Leistner, Natalia, Thompson, Amy, Gonzalez, Celia, Jackson, Lisa A., Suyehira, Janice, Haber, Milton, Regalado, Maria M., Procasky, Veronica, Lutat, Alisha, Griffin, Carl P., Hollister, Ripley R., Brown, Jeremy, Ronk, Melody, Harper, Wayne L., Cohen, Lisa, Eckert, Lynn, Hong, Matthew, Rouhbakhsh, Rambod, Danford, Elizabeth, Johnson, John, Calderone, Richard, Khetan, Shishir K., Olanrewaju, Oyebisi, Zhai, Nan, Nieves, Kimberly, O'Brien, Allison, Bradley, Paul S., Lilienthal, Amanda, Callis, Jim, Brosz, Adam B., Clement, Andrea, West, Whitney, Friesen, Luke, Cramer, Paul, Eder, Frank S., Little, Ryan, Engler, Victoria, Rattenbury-Shaw, Heather, Ensz, David J., Oplinger, Allie, Essink, Brandon J., Meyer, Jay, Raiser, Frederick, III, Mueller, Kimberly, Vrbicky, Keith W., Harper, Charles, Nutsch, Chelsie, Lewis, Wendell, III, Laflan, Cathy, Whatley, Jordan L., Harrell, Nicole, Shannon, Amie, Rowell, Crystal, Dedon, Christopher, Makhene, Mamodikoe, Gottschlich, Gregory M., Harden, Kate, Gottschlich, Melissa, Smith, Mary, Powell, Richard, Kimmel, Murray A., Pinto, Simmy, Vachris, Timothy P., Hutchens, Mark, Daniels, Stephen, Wells, Margaret, Van Der Leden, Mimi, Jackson-Booth, Peta-Gay, Baron, Mira, Kane, Pamela, Seversen, Shannen, Kryvicky, Mara, Lord, Julia, Saleh, Jamshid, Miles, Matthew, Lupercio, Rafael, McGettigan, John W., Jr., Patton, Walter, Brakema, Riemke, Choquette, Karin, McGettigan, Jonlyn, Kirstein, Judith L., Bernard, Marcia, Manning, Mary Beth, Rothenberg, Joan, Briskin, Toby, Roadman, Denise, Tedder-Edwards, Sharita, Schwartz, Howard I., Mederos, Surisday, Swaminathan, Shobha, Nyaku, Amesika, Varughese, Tilly, DallaPiazza, Michelle, Frey, Sharon E., Graham, Irene, Abate, Getahun, Hoft, Daniel, Allen, Leland N., III, Edwards, Leslie A., Davis, William S., Jr., Mena, Jessica M., Kutner, Mark E., Caso, Jorge, Moran, Maria Hernandez, Carvajal, Marianela, Mendez, Janet, Wadsworth, Larkin T., III, Adams, Michael R., Iverson, Leslie, Newberg, Joseph L., Pearlman, Laura, Nugent, Paul J., Reynolds, Michele D., Bashour, Jennifer, Schmidt, Robert, Sheth, Neil P., Steil, Kenneth, Toma, Ramy J., Kirby, William, Folmar, Pink, Williams, Samantha, Pickrell, Paul, Mott, Stefanie, Linebarger, Carol Ann, Malbari, Hussain, Pampe, David, Fragoso, Veronica G., Holloway, Lisa, McKeown-Bragas, Cecilia, Becker, Teresa, Williams, Barton G., Jones, William H., Clark, Jesse L., Shoptaw, Steven, Vertucci, Michele, Hernandez, Will, Spector, Stephen A., Moodley, Amaran, Blumenthal, Jill, Stangl, Lisa, Deutsch, Karen, Mullane, Kathleen M., Pitrak, David, Nuss, Cheryl, Pi, Judy, Fichtenbaum, Carl, Powers-Fletcher, Margaret, Saemann, Michelle, Kohrs, Sharon, Campbell, Thomas B., Lauria, Andrew, Mancilla, Jose C., Dunlevy, Hillary, Novak, Richard M., Wendrow, Andrea, Borgetti, Scott, Ladner, Ben, Chrisley, Lisa, Young, Cheryl, Doblecki-Lewis, Susanne, Alcaide, Maria L., Gonzales-Zamora, Jose, Morris, Stephen, Wohl, David, Eron, Joseph, Jr., Frank, Ian, Dunbar, Debora, Metzger, David, Momplaisir, Florence, Martin, Judith, Hoberman, Alejandro, Shope, Timothy, Muniz, Gysella, Rupp, Richard, Stanford, Amber, Berman, Megan, Porterfield, Laura, Lewis, Michael, Ghadishah, Elham, Yusin, Joseph, Pham, Mai, Creech, Clarence B., II, Walker, Shannon, Rolsma, Stephanie, Samuels, Robert, Thomsen, Isaac, Kalams, Spyros A., Wilson, Greg, Lucksinger, Gregg H., Parks, Kevin, Israelsen, Ryan, Ostovar, Jaleh, Kelly, Kary, Overcash, Jeffrey S., Chu, Hanh, Lee, Kia, De La Cruz, Luis I., Clemons, Steve, Everette, Elizabeth, Studdard, Suzanna, Mohan, Gowdhami, Tyson, Stefanie, Peay, Alyssa-Kay, Johnson, Danyel, Feldman, Gregory J., Suen, May-Yin, Muenzner, Jacqueline, Boscia, Joseph, Siddiqui, Farhan, Sanders, John, Peacock, James, Nasim, Julio, Levin, Michael L., Hussey, Julie, Kulic, Marcy, McKenzie, Mark M., Deese, Teresa, Osmundsen, Erica, Sweet, Christy, Ebuh, Valentine M., Elnagar, Elwaleed, Ebuh, Georgette, Iwuala, Genevieve, Han-Conrad, Laurie J., Simmons, Todd, Tarakjian, Denis, Ackermann, Jeremy, Adams, Mark S., Alemán, José O., Al-Ibrahim, Mohamed S., Andes, David R., Andrews, Jeb, Arduino, Roberto C., Bäcker, Martín, Badillo, Diana, Bainbridge, Emma, Batteiger, Teresa A., Bazan, Jose A., Bedimo, Roger J., Benitez, Jorge A., Bennett, Annette R., Bernstein, David I., Bialobok, Kristin, Boas, Rebecca, Brady, Judith, Brown, Cynthia, Bunce, Catherine A., Call, Robert S., Campbell, Wesley, Carmody, Ellie, Carpenter, Christopher, Carsons, Steven E., Castellon, Marvin, Castro, Mario, Catan, Hannah, Chang, Jennifer, Chebib, Mouna G., Chen, Corey M., Cheng, Margaret, Chow, Brian D.W., Ciambruschini, Annie, Connor, Joseph P., Conway, James H., Cooney, Maureen, Curlin, Marcel, De La Matta Rodriguez, Claudia, Dedon, Jon F., Degan, Emily, Dickey, Michelle, Dietz, Craig, Dong, Jennifer L., Dorcely, Brenda, Dube, Michael P., Dyer, Carmel B., Eckhardt, Benjamin, Ellerbeck, Edward, Ewers, Evan C., Falk, Amy, Feijoo, Brittany, Felsen, Uriel R., Fiel, Tom, Fitz-Patrick, David, Fogarty, Charles M., Ford, Stacy, Forero, Lina M., Formentini, Elizabeth, Franco-Vitteri, Doris, Frenck, Robert W., Jr., Gharib, Elie, Gharib, Suzanne, Rucker, Rola G., Goldenberg, James N., González, Luis H., Gray, Brett, Greene, Rusty, Grossberg, Robert M., Guanira-Carranza, Juan V., Guerreros Benavides, Alfredo Gilberto, Guillory, Clint C., Gunaratne, Shauna H., Halpert, David, Hamilton, Holli, Hartman, William R., Henderson, Sheryl L., Herati, Ramin, Guarin, Laura Hernandez, Hilder, Robin, Ho, Ken, Hojat, Leila, Hosek, Sybil G., Jacobson, Jeffrey M., Jay, Melanie, Johnson, Diane H., Jones, Kathleen S., Jones-López, Edward C., Justman, Jessica E., Kahney, Scott, Katz, Lois, Katz, Melinda, Kaul, Daniel, Keefer, Michael C., Kennedy, Ashley, Knishinsky, Jennifer, Kogelman, Laura, Koletar, Susan L., Kottkamp, Angelica, Laguio-Vila, Maryrose, Landovitz, Raphael J., Lee, Jessica L., Liu, Albert, Llerena Zegarra, Eneyda Giuvanela, Lok, Anna S., Lovell, James, Lubelchek, Ronald, Lucaj, John, Luckasen, Gary, Luetkemeyer, Annie, Lugogo, Njira Lucia, Maenza, Janine, Malvestutto, Carlos, Mauri, Monica, Maves, Ryan C., Mayer, Kenneth H., McCartney, Michael J., McCort, Margaret E., McElrath, M. Juliana, McNairy, Meredith, Merino, Fernando L., Meyerowitz, Eric A., Mitchell, Carol L., Monaco, Cynthia L., Muhammad, Sauda, Muñoz-Gómez, Sigridh, Munsiff, Sonal, Nee, Paul, Nollen, Nicole L., Noor, Asif, Lagos, Claudio Nuñez, Okulicz, Jason F., Oliver, Patrick A., Ortega, Jessica, Palmer, Steven, Parameswaran, Lalitha, Parikh, Purvi, Parker, Susan, Parungao, Reza, Pavie, Juana R., Madan, Rebecca P., Peralta, Henry, Petts, Jennifer, Pierce, Kristen K., Pretell Alva, E. Javier, Purpura, Lawrence J., Raabe, Vanessa, Recuenco, Sergio E., Richards, Tamara, Riddler, Sharon A., Rizzardi, Barbara, Rokser, Rachel, Rolle, Charlotte-Paige, Rosen, Adam, Rosen, Jeffrey, Freese, Lena R., Santolaya, María E., Schipani, Linda M., Schwartz, Adam, Schwasinger-Schmidt, Tiffany, Scott, Hyman, Sha, Beverly E., Shankaran, Shivanjali, Shapiro, Adrienne E., Sharp, Stephan C., Shopsin, Bo, Sims, Matthew D., Skipper, Stephanie, Smith, Derek M., Smith, Michael J., Sobhanie, M. Mahdee, Sovic, Brit, Sterling, Stephanie, Striker, Robert, Tafur Bances, Karla Beatriz, Talaat, Kawsar R., Tavel, Edward M., Jr., Tieu, Hong V., Tomaszewski, Christian, Tomlinson, Ryan, Torres, Juan P., Torres, Julian A., Treanor, John J., Tukuru, Sade, Ulrich, Robert J., Utz, Gregory C., Viar, Veronica, Viau Colindres, Roberto A., Walsh, Edward E., Walsh, Mary C., Walter, Emmanuel B., Weidler, Jessica L., Wu, Yi H., Yang, Kinara S., Yrivarren Giorza, Juan Luis, Zemanek, Arthur L., Zhang, Kevin, Zingman, Barry S., Gorman, Richard, Paez, Carmen A., Swann, Edith, Takuva, Simbarashe G., Greninger, Alex, Roychoudhury, Pavitra, Coombs, Robert W., Jerome, Keith R., Castellino, Flora, Tong, Xiaomi, Pavetto, Corrina, Gipson, Teletha, Tong, Tina, Lee, Marina, Zhou, James, Fay, Michael, McQuarrie, Kelly, Nnadi, Chimeremma, Sogbetun, Obiageli, Ahmad, Nina, De Proost, Ian, Hoseyni, Cyrus, Coplan, Paul, Khan, Najat, Ronco, Peter, Furey, Dawn, Meck, Jodi, Vingerhoets, Johan, Brandenburg, Boerries, Custers, Jerome, Hendriks, Jenny, Juraszek, Jarek, Marit de Groot, Anne, Van Roey, Griet, Heerwegh, Dirk, Van Dromme, Ilse, Méndez Galván, Jorge F., Carrascal, Monica B., Duran, Adriana Sordo, Sanchez Guerrero, Laura Ruy, Gómora Madrid, Martha Cecilia, Barrat Hernández, Alejandro Quintín, Guizar, Sharzhaad Molina, González Estrada, Denisse Alejandra, Martínez Pérez, Silvano Omar, Zárate Hinojosa, Zindy Yazmín, Ruiz-Palacios, Guillermo Miguel, Cruz-Valdez, Aurelio, Pacheco-Flores, Janeth, Lara, Anyela, Díaz-Miralrio, Secia, Reyes Fentanes, María José, Olmos Vega, Jocelyn Zuleica, Méndez, Daniela Pineda, Martínez, Karina Cano, Alvarez León, Winniberg Stephany, Ruiz Herrera, Vida Veronica, Vázquez Saldaña, Eduardo Gabriel, Camacho Choza, Laura Julia, Vega Orozco, Karen Sofia, Ortega Domínguez, Sandra Janeth, Chacón, Jorge A., Rivera, Juan J., Cutz, Erika A., Ortegón, Maricruz E., Rivera, María I., Browder, David, Burch, Cortney, Moye, Terri, Bondy, Paul, Browder, Lesley, Manning, Rickey D., Hurst, James W., Sturgeon, Rodney E., Wakefield, Paul H., Kirby, John A., Andersen, James, Fearon, Szheckera, Negron, Rosa, Medina, Amy, Hill, John M., Rajasekhar, Vivek, Williams, Hayes, Cade, LaShondra, Fouts, Rhodna, Moya, Connie, Anderson, Corey G., Devine, Naomi, Ramsey, James, Perez, Ashley, Tatelbaum, David, Jacobs, Michael, Menasche, Kathleen, Mirkil, Vincent, Winkle, Peter J., Haggag, Amina Z., Haynes, Michelle, Villegas, Marysol, Raja, Sabina, Riesenberg, Robert, Plavin, Stanford, Lerman, Mark, Woodside, Leana, Johnson, Maria, Healy, C. Mary, Whitaker, Jennifer A., Keitel, Wendy A., Atmar, Robert L., Horwith, Gary, Mason, Robin, Johnson, Lisa, Dora, Tambra, Murray, Deborah, Ledbetter, Logan, Ewing, Beverly, Stephenson, Kathryn E., Tan, Chen S., Zash, Rebecca, Ansel, Jessica L., Jaegle, Kate, Guiney, Caitlin J., Henderson, Jeffrey A., O'Leary, Marcia, Enright, Kendra, Kessler, Jill, Ducheneaux, Pete, Inniss, Asha, Brandon, Donald M., Davis, William B., Lawler, Daniel T., Oppong, Yaa D., Starr, Ryan P., Syndergaard, Scott N., Shelly, Rozeli, Majumder, Mashrur Islam, Sugimoto, Danny, Dugas, Jeffrey, Sr., Rijos, Dolores, Shelton, Sandra, Hong, Stephan, Schwartz, Howard, Sanchez-Crespo, Nelia, Schwartz, Jennifer, Piedra, Terry, Corral, Barbara, Medina, Carmen, Dever, Michael E., Shah, Mitul, Delgado, Michael, Scott, Tameika, Usdan, Lisa S., McGill, Lora J., Arnold, Valerie K., Scatamacchia, Carolyn, Anthony, Codi M., Merchant, Rajan, Yoon, Anelgine C., Hill, Janet, Ng-Price, Lucy, Thompson-Seim, Teri, Ackerman, Ronald, Ackerman, Jamie, Aristy, Florida, Ketter, Nzeera, Finley, Jon, Stull, Mildred, Murray, Monica, Rizvi, Zainab, Guerrero, Sonia, Paliwal, Yogesh K., Paliwal, Amit, Gordon, Sarah, Gordon, Bryan, Montano-Pereira, Cynthia, Galloway, Christopher, Montros, Candice, Aleman, Lily, Shairi, Samira, Van Ever, Wesley, Freeman, George H., Harmon, Esther L., Cross, Marshall A., Sales, Kacie, Gular, Catherine Q., Hepburn, Matthew, Alderson, Nathan, Harshell, Shana, Mahgoub, Siham, Maxwell, Celia, Mellman, Thomas, Thompson, Karl M., Wortman, Glenn, Kingsley, Jeff, Pixler, April, Curry, LaKondria, Afework, Sarah, Swanson, Austin, Jacqmein, Jeffry, Bowers, Maggie, Robison, Dawn, Mosteller, Victoria, Garvey, Janet, Easley, Mary, Kurnat, Rebecca J., Cornelison, Raymond, Gower, Shanda, Schnitz, William, Heinzig-Cartwright, Destiny S., Lewis, Derek, Newton, Fred E., Duhart, Aeiress, Watkins, Breanz, Ball, Brandy, York, Jill, Pickle, Shelby, Musante, David B., Silver, William P., Belhorn, Linda R., Viens, Nicholas A., Dellaero, David, Patel, Priti, Lisec, Kendra, Safirstein, Beth, Zapata, Luz, Gonzalez, Lazaro, Quevedo, Evelyn, Irani, Farah, Grillo, Joseph, Potts, Amy, White, Julie, Flume, Patrick, Headden, Gary, Taylor, Brandie, Warden, Ashley, Chamberlain, Amy, Jeanfreau, Robert, Jeanfreau, Susan, Matherne, Paul G., Caldwell, Amy, Stahl, Jessica, Vowell, Mandy, Newhouse, Lauren, Berthaud, Vladimir, Takizala, Zudi-Mwak, Beninati, Genevieve, Snell, Kimberly, Baker, Sherrie, Walker, James, Harrison, Tavane, Miller, Meagan, Otto, Janet, Gray, Roni, Wilson, Christine, Nemecek, Tiffany, Harrington, Hannah, Eppenbach, Sally, Lewis, Wendell, Bourgeois, Tana, Folsom, Lyndsea, Holt, Gregory, Mirsaeidi, Mehdi, Calderon, Rafael, Lichtenberger, Paola, Quintero, Jalima, Martinez, Becky, Immergluck, Lilly, Johnson, Erica, Chan, Austin, Fas, Norberto, Thomas-Seaton, LaTeshia, Khizer, Saadia, Staben, Jonathan, Beresnev, Tatiana, Jahromi, Maryam, Marovich, Mary A., Hutter, Julia, Nason, Martha, Ledgerwood, Julie, Mascola, John, Leibowitz, Mark, Morales, Fernanda, Delgado, Mike, Sanchez, Rosario, Vega, Norma, Áñez, Germán, Albert, Gary, Coston, Erin, Desai, Chinar, Dunbar, Haoua, Eickhoff, Mark, Garcia, Jenina, Kautz, Margaret, Lee, Angela, Lewis, Maggie, McGarry, Alice, McKnight, Irene, Nelson, Joy, Newingham, Patrick, Price-Abbott, Patty, Reed, Patty, Vegas, Diana, Wilkinson, Bethanie, Smith, Katherine, Woo, Wayne, Cho, Iksung, Glenn, Gregory M., Dubovsky, Filip, Fried, David L., Haughey, Lynne A., Stanton, Ariana C., Rameaka, Lisa Stevens, Rosenberg, David, Tomatsu, Lee, Gonzalez, Viviana, Manalo, Millie, Grunstra, Bernard, Quinn, Donald, Claybrook, Phillip, Olds, Shelby, Dye, Amy, Cannon, Kevin D., Chadwick, Mesha M., Jordan, Bailey, Hussey, Morgan, Nevarez, Hannah, Kelley, Colleen F., Chung, Michael, Moran, Caitlin, Rebolledo, Paulina, Bacher, Christina, Barranco-Santana, Elizabeth, Rodriguez, Jessica, Mendoza, Rafael, Ruperto, Karen, Olivieri, Odette, Ocaña, Enrique, Wylie, Paul E., Henderson, Renea, Jenson, Natasa, Yang, Fan, Kelley, Amy, Finkelstein, Kenneth, Beckmann, David, Hutchins, Tanya, Escallon, Sebastian Garcia, Johnson, Kristen, Sligh, Teresa S., Desai, Parul, Huynh, Vincent, Lopez, Carlos, Mendoza, Erika, Adelglass, Jeffrey, Naifeh, Jerome G., Kucera, Kristine J., Chughtai, Waseem, Jaffer, Shireen H., Davis, Matthew G., Foley, Jennifer, Burgett, Michelle L., Shlotzhauer, Tammi L., Ingalsbe-Geno, Sarah M., Duncanson, Daniel, Kush, Kelly, Nesbitt, Lori, Sonnier, Cora, McCarter, Jennifer, Butcher, Michael B., Fry, James, Percy, Donna, Freudemann, Karen, Gebhardt, Bruce C., Mangu, Padma N., Schroeck, Debra B., Davit, Rajesh K., Hennekes, Gayle D., Luft, Benjamin J., Carr, Melissa, Nachman, Sharon, Pellecchia, Alison, Smith, Candace, Valenti, Bruno, Bermudez, Maria I., Peraita, Noris, Delgado, Ernesto, Arrazcaeta, Alicia, Ramirez, Natalie, Amador, Carmen, Marafioti, Horacio, Dang, Lyly, Clement, Lauren, Berry, Jennifer, Allaw, Mohammed, Geuss, Georgettea, Miles, Chelsea, Bittner, Zachary, Werne, Melody, Calinescu, Cornell, Rodman, Shannon, Rindt, Joshua, Cooksey, Erin, Harrison, Kristina, Cooper, Deanna, Horton, Manisha, Philyaw, Amanda, Jennings, William, Alvarado, Hilario, Baka, Michele, Regalado, Malina, Murray, Linda, Naguib, Sherif, Singletary, Justin, Richmond, Sha-Wanda, Omodele, Sarah, Oppenheim, Emily, Martinez, Reuben, Andriulis, Victoria, Singer, Leonard, Blevins, Jeanne, Thomas, Meagan, Hull, Christine, Pereira, Isabel, Rivero, Gina, Okonya, Tracy, Downing, Frances, Miller, Paulina, Rhee, Margaret, Stapleton, Katherine, Klein, Jeffrey, Hong, Rosamond, Swan, Suzanne, Wahlin, Tami, Bennett, Elizabeth, Salzl, Amy, Phan, Sharine, White, Jewel J., Occhino, Amanda, Paiano, Ruth, McLaughlin, Morgan, Swieboda, Elisa, Garcia-Fragoso, Veronica, Becerra, Maria G., White, Toni, Turley, Christine B., McWilliams, Andrew, Esinhart, Tiffany, Montoya, Natasha, Huskey, Shamika, Paul, Leena, Tashima, Karen, Johnson, Jennie, Neill, Marguerite, Sanchez, Martha, Rybak, Natasha, Mileno, Maria, Cohen, Stuart H., Ruiz, Monica, Boswell, Dean M., Robison, Elizabeth E., Reynolds, Trina L., Neumeister, Sonja, Zorrilla, Carmen D., Rivera, Juana, Ibarra, Jessica, García, Iris, Sierra, Dianca, Ramon, Wanda, Fiorillo, Suzanne, Pitotti, Rebecca, Anderson, Victoria R., Mancilla, Jose Castillo, Le, Nga, Winokur, Patricia L., Ince, Dilek, Hegmann, Theresa, Meier, Jeffrey, Stapleton, Jack, Stulken, Laura, McArthur, Monica, Berry, Andrea, Tapia, Milagritos, Hammershaimb, Elizabeth, Robinson, Toni, MacBryde, Rosa, Kline, Susan, Billings, Joanne L., Cavert, Winston, Forgosh, Les B., Schacker, Timothy W., Bold, Tyler D., Dandachi, Dima, Nelson, Taylor, Bran, Andres, Geiger, Grant, Naqvi, S. Hasan, Florescu, Diana F., Starlin, Richard, Kline, David, Zimmer, Andrea, Abbas, Anum, Wilson, Natasha, Eron, Joseph J., Sciaudone, Michael, Rosengren, A. Lina, Kizer, John S., Rutstein, Sarah E., Bruce, Elizabeth, Espinosa, Claudia, Sanders, Lisa J., Kim, Kami, Casey, Denise, Taylor, Barbara S., Patterson, Thomas, Pinilla, Ruth S., Bullock, Delia, Ponce, Philip, Patterson, Jan, McClelland, R. Scott, Lane, Dakotah C., Wald, Anna, James, Frank, Duke, Elizabeth, Hauge, Kirsten, Heimonen, Jessica, Goecker, Erin A., Huang, Yunda, Fong, Youyi, Kauffman, Carol, Linder, Kathleen, Nofz, Kimberly, McConnell, Andrew, Buynak, Robert J., Webb, Angella, Petty, Taryn, Andree, Stephanie, Sanchez, Erica, Mackey, Nolan, Baudelaire, Clarisse, Dzigiel, Sarah, Marquez, Adrienna, Quillin, Kim, King, Michelle, Abad, Vanessa, Knowles, Jennifer, Waters, Michael, Zepeda, Karla, Coslet, Jordan, Tovar, Dalia, Shaw, Marian E., Turner, Mark A., Huffine, Cory J., Huffine, Esther S., Ake, Julie A., Secord, Elizabeth, McGrath, Eric, Levy, Phillip, Stewart, Brittany, Cromer, Charnell, Walters, Ayanna, Ellsworth, Grant, Greene, Caroline, Galloway, Sarah, Kapadia, Shashi, DeHaan, Elliot, Wilson, Clint, Milligan, Jason, Raley, Danielle, Bocchini, Joseph, McClenathan, Bruce, Hussain, Mary, Lomasney, Evelyn, Hall, Evelyn, Lamberth, Sherry, Schmeck, Christy, Leathers, Vickie, Theodore, Deborah A., Branche, Angela R., Graciaa, Daniel S., Hatlen, Timothy J., Miller, Jacqueline, Sadoff, Jerald, Falsey, Ann R., Sobieszczyk, Magdalena E., Rick, Anne-Marie, Laurens, Matthew B., Huang, Ying, Yu, Chenchen, Martin, Thomas C.S., Rodriguez, Carina A., Rostad, Christina A., Maboa, Rebone M., Baden, Lindsey R., El Sahly, Hana M., Grinsztejn, Beatriz, Gray, Glenda E., Gay, Cynthia L., Gilbert, Peter B., Janes, Holly E., Kublin, James G., Leav, Brett, Hirsch, Ian, Struyf, Frank, Dunkle, Lisa M., Neuzil, Kathleen M., Corey, Lawrence, Goepfert, Paul A., Follmann, Dean, and Kotloff, Karen L.
Published: 2023
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35. Efficacy of a monovalent (D614) SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant in adults: a phase 3, multi-country study

Author: Abalos, Karina, Adams, Michael, Allaw, Mohamed, Aloysia, Naveena, Amuasi, John Humphrey, Ansah, Nana Akosua, Asante, Kwaku Poku, Benkeser, David, Berge, Aude, Breuer, Thomas, Briesemeister, Liz, Broder, Gail, Bonfanti, Alberto Cadena, Calinescu, Cornell, Canter, Richard, Carrillo, Jaime Augusto, Chansinghakul, Danaya, Coux, Florence, Das, Chandan, Davies, Matthew, Devlin, Louis, Fay, Michael, Follmann, Dean, Frago, Carina, Fukase, Hiroyuki, Garinga, Agnes, Gilbert, Peter B., Gonzalez, Claudia, Granados, Maria Angelica, Greiwe, Cathy, Guillery, Lea, Hall, Jessicalee, Henderson, Jeffrey, Huang, Ying, Hudzina, Kathy, Hural, John, Hutchens, Mark, Jain, Manish, Jennings, William, Kanodia, Piush, Kimmel, Murray, Kirby, William, Khandelwal, Nitin, Kopp, James, Kosolsak, Chalit, Kublin, Jim, Kukian, Darshna, Kushwaha, Jitendra Singh, Laot, Thelma, Lopez-Medina, Eduardo, Arroyo, Hugo Macareno, Mamod, Stephanie, Mangarule, Somnath, Martin, Troy, Menard, Lisa, Mendoza, Sandra, Meyer, Robert, Middleton, Randle, Miracle, Jill, Mizuyama, Kazuyuki, Mohapatra, Satyajit, Moreau, Catherine, Murray, Linda, Nagamatsu, Shinya, Newberg, Joseph, Noriega, Fernando, Nugent, Paul, Peake-Andrasik, Michele, Pekala, David, Peng, Penny, Py, Marie-Laure, Ramirez, Shelly, Reddy, Chinthaparthi Prabhakar, Reynolds, Michelle, Rivas, Enrique, Sater, Nessryne, Shah, Jinen, Sher, Lawrence, Sieger, Silva, Singh, Chandramani, Singh, Veer Bahadur, Sirisuphmitr, Nuchra, Starkey, Thomas, Suzuki, Kazuo, Tamrakar, Dipesh, Tangemen, Cayce, Da-Silva, Fernanda Tavares, Taylor, David, Tharenos, Leslie, Wartel, T. Anh, Zaworski, Elodie, Zhang, Nianxian, Dayan, Gustavo H., Rouphael, Nadine, Walsh, Stephen R., Chen, Aiying, Grunenberg, Nicole, Allen, Mary, Antony, Johannes, Bhate, Amit Suresh, Beresnev, Tatiana, Bonaparte, Matthew I., Celle, Médéric, Ceregido, Maria Angeles, Corey, Lawrence, Fu, Bo, Grillet, Marie-Helene, Keshtkar-Jahromi, Maryam, Juraska, Michal, Kee, Jia Jin, Kaali, Seyram, Koutsoukos, Marguerite, Masotti, Roger, Michael, Nelson L., Neuzil, Kathleen M., Reynales, Humberto, Robb, Merlin L., Uchiyama, Akiyoshi, Sawe, Fredrick, Schuerman, Lode, Shrestha, Rajeev, Tong, Tina, Treanor, John, Diazgranados, Carlos A., Chicz, Roman M., Gurunathan, Sanjay, Savarino, Stephen, and Sridhar, Saranya
Published: 2023
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36. Serum concentration of antigen-specific IgG can substantially bias interpretation of antibody-dependent phagocytosis assay readout

Author: St. Germain, Russell, Bossard, Emily L., Corey, Lawrence, and Sholukh, Anton M.
Published: 2023
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37. Real-World Effectiveness of Sotrovimab for the Early Treatment of COVID-19 During SARS-CoV-2 Delta and Omicron Waves in the USA

Author: Cheng, Mindy M., Reyes, Carolina, Satram, Sacha, Birch, Helen, Gibbons, Daniel C., Drysdale, Myriam, Bell, Christopher F., Suyundikov, Anvar, Ding, Xiao, Maher, M. Cyrus, Yeh, Wendy, Telenti, Amalio, and Corey, Lawrence
Published: 2023
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38. Chimeric TIM-4 receptor-modified T cells targeting phosphatidylserine mediates both cytotoxic anti-tumor responses and phagocytic uptake of tumor-associated antigen for T cell cross-presentation

Author: Cieniewicz, Brandon, Bhatta, Ankit, Torabi, Damoun, Baichoo, Priya, Saxton, Mike, Arballo, Alexander, Nguyen, Linh, Thomas, Sunil, Kethar, Harini, Kukutla, Phanidhar, Shoaga, Omolola, Yu, Bi, Yang, Zhuo, Fate, Maria, Oliveira, Edson, Ning, Hongxiu, Corey, Lawrence, and Corey, Daniel
Published: 2023
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39. Pharmacokinetic serum concentrations of VRC01 correlate with prevention of HIV-1 acquisition

Author: Seaton, Kelly E., Huang, Yunda, Karuna, Shelly, Heptinstall, Jack R., Brackett, Caroline, Chiong, Kelvin, Zhang, Lily, Yates, Nicole L., Sampson, Mark, Rudnicki, Erika, Juraska, Michal, deCamp, Allan C., Edlefsen, Paul T., Mullins, James I., Williamson, Carolyn, Rossenkhan, Raabya, Giorgi, Elena E., Kenny, Avi, Angier, Heather, Randhawa, April, Weiner, Joshua A., Rojas, Michelle, Sarzotti-Kelsoe, Marcella, Zhang, Lu, Sawant, Sheetal, Ackerman, Margaret E., McDermott, Adrian B., Mascola, John R., Hural, John, McElrath, M. Julianna, Andrew, Philip, Hidalgo, Jose A., Clark, Jesse, Laher, Fatima, Orrell, Catherine, Frank, Ian, Gonzales, Pedro, Edupuganti, Srilatha, Mgodi, Nyaradzo, Corey, Lawrence, Morris, Lynn, Montefiori, David, Cohen, Myron S., Gilbert, Peter B., and Tomaras, Georgia D.
Published: 2023
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40. Novel engineered chimeric engulfment receptors trigger T cell effector functions against SIV-infected CD4+ T cells

Author: Corey, Daniel, Haeseleer, Francoise, Hou, Joe, and Corey, Lawrence
Published: 2023
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41. Neutralization titer biomarker for antibody-mediated prevention of HIV-1 acquisition

Author: Gilbert, Peter B., Huang, Yunda, deCamp, Allan C., Karuna, Shelly, Zhang, Yuanyuan, Magaret, Craig A., Giorgi, Elena E., Korber, Bette, Edlefsen, Paul T., Rossenkhan, Raabya, Juraska, Michal, Rudnicki, Erika, Kochar, Nidhi, Huang, Ying, Carpp, Lindsay N., Barouch, Dan H., Mkhize, Nonhlanhla N., Hermanus, Tandile, Kgagudi, Prudence, Bekker, Valerie, Kaldine, Haajira, Mapengo, Rutendo E., Eaton, Amanda, Domin, Elize, West, Carley, Feng, Wenhong, Tang, Haili, Seaton, Kelly E., Heptinstall, Jack, Brackett, Caroline, Chiong, Kelvin, Tomaras, Georgia D., Andrew, Philip, Mayer, Bryan T., Reeves, Daniel B., Sobieszczyk, Magdalena E., Garrett, Nigel, Sanchez, Jorge, Gay, Cynthia, Makhema, Joseph, Williamson, Carolyn, Mullins, James I., Hural, John, Cohen, Myron S., Corey, Lawrence, Montefiori, David C., and Morris, Lynn
Published: 2022
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42. SWIFT clustering analysis of intracellular cytokine staining flow cytometry data of the HVTN 105 vaccine trial reveals high frequencies of HIV-specific CD4+ T cell responses and associations with humoral responses

Author: Mosmann, Tim R., primary, Rebhahn, Jonathan A., additional, De Rosa, Stephen C., additional, Keefer, Michael C., additional, McElrath, M. Juliana, additional, Rouphael, Nadine G., additional, Pantaleo, Giuseppe, additional, Gilbert, Peter B., additional, Corey, Lawrence, additional, Kobie, James J., additional, and Thakar, Juilee, additional
Published: 2024
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43. Antigenic competition in CD4+ T cell responses in a randomized, multicenter, double-blind clinical HIV vaccine trial.

Author: Kallas, Esper, Grunenberg, Nicole, Yu, Chenchen, Manso, Bryce, Pantaleo, Giuseppe, Casapia, Martin, Baden, Lindsey, Valencia, Javier, Sobieszczyk, Magdalena, Van Tieu, Hong, Allen, Mary, Hural, John, Graham, Barney, Kublin, James, Gilbert, Peter, Corey, Lawrence, Goepfert, Paul, McElrath, M, Johnson, R, Huang, Yunda, and Frahm, Nicole
Subjects: AIDS Vaccines, Adolescent, Adult, CD4-Positive T-Lymphocytes, CD8-Positive T-Lymphocytes, Double-Blind Method, Epitopes, Female, HIV Antigens, Humans, Male, Middle Aged, Vaccination, Young Adult, env Gene Products, Human Immunodeficiency Virus, gag Gene Products, Human Immunodeficiency Virus
Abstract: T cell responses have been implicated in reduced risk of HIV acquisition in uninfected persons and control of viral replication in HIV-infected individuals. HIV Gag-specific T cells have been predominantly associated with post-infection control, whereas Env antigens are the target for protective antibodies; therefore, inclusion of both antigens is common in HIV vaccine design. However, inclusion of multiple antigens may provoke antigenic competition, reducing the potential effectiveness of the vaccine. HVTN 084 was a randomized, multicenter, double-blind phase 1 trial to investigate whether adding Env to a Gag/Pol vaccine decreases the magnitude or breadth of Gag/Pol-specific T cell responses. Fifty volunteers each received one intramuscular injection of 1 × 1010 particle units (PU) of rAd5 Gag/Pol and EnvA/B/C (3:1:1:1 mixture) or 5 × 109 PU of rAd5 Gag/Pol. CD4+ T cell responses to Gag/Pol measured 4 weeks after vaccination by cytokine expression were significantly higher in the group vaccinated without Env, whereas CD8+ T cell responses did not differ significantly between the two groups. Mapping of individual epitopes revealed greater breadth of the Gag/Pol-specific T cell response in the absence of Env compared to Env coimmunization. Addition of an Env component to a Gag/Pol vaccine led to reduced Gag/Pol CD4+ T cell response rate and magnitude as well as reduced epitope breadth, confirming the presence of antigenic competition. Therefore, T cell-based vaccine strategies should aim at choosing a minimalist set of antigens to reduce interference of individual vaccine components with the induction of the maximally achievable immune response.
Published: 2019

44. Acute Infection and Subsequent Subclinical Reactivation of Herpes Simplex Virus 2 after Vaginal Inoculation of Rhesus Macaques

Author: Lo, Ming, Zhu, Jia, Hansen, Scott G, Carroll, Timothy, Zuend, Christina Farr, Nöel-Romas, Laura, Ma, Zhong-Min, Fritts, Linda, Huang, Meei-Li, Sun, Sijie, Huang, Ying, Koelle, David M, Picker, Louis J, Burgener, Adam, Corey, Lawrence, and Miller, Christopher J
Subjects: Medical Microbiology, Biomedical and Clinical Sciences, Immunology, HIV/AIDS, Sexually Transmitted Infections, Prevention, Infectious Diseases, 2.1 Biological and endogenous factors, 2.2 Factors relating to the physical environment, Infection, Good Health and Well Being, Acantholysis, Animals, Disease Models, Animal, Female, Herpes Simplex, Herpesvirus 2, Human, Humans, Macaca mulatta, T-Lymphocytes, Vagina, Virus Latency, Virus Shedding, female reproductive tract, T-cell responses, cervix, herpes simplex virus, proteomics, subclinical infection, vaginal swabs, Biological Sciences, Agricultural and Veterinary Sciences, Medical and Health Sciences, Virology, Agricultural, veterinary and food sciences, Biological sciences, Biomedical and clinical sciences
Abstract: Herpes simplex virus 2 (HSV-2) is a common sexually transmitted infection with a highly variable clinical course. Many infections quickly become subclinical, with episodes of spontaneous virus reactivation. To study host-HSV-2 interactions, an animal model of subclinical HSV-2 infection is needed. In an effort to develop a relevant model, rhesus macaques (RM) were inoculated intravaginally with two or three HSV-2 strains (186, 333, and/or G) at a total dose of 1 × 107 PFU of HSV-2 per animal. Infectious HSV-2 and HSV-2 DNA were consistently shed in vaginal swabs for the first 7 to 14 days after each inoculation. Proteins associated with wound healing, innate immunity, and inflammation were significantly increased in cervical secretions immediately after HSV-2 inoculation. There was histologic evidence of acute herpesvirus pathology, including acantholysis in the squamous epithelium and ballooning degeneration of and intranuclear inclusion bodies in epithelial cells, with HSV antigen in mucosal epithelial cells and keratinocytes. Further, an intense inflammatory infiltrate was found in the cervix and vulva. Evidence of latent infection and reactivation was demonstrated by the detection of spontaneous HSV-2 shedding post-acute inoculation (102 to 103 DNA copies/swab) in 80% of RM. Further, HSV-2 DNA was detected in ganglia in most necropsied animals. HSV-2-specifc T-cell responses were detected in all animals, although antibodies to HSV-2 were detected in only 30% of the animals. Thus, HSV-2 infection of RM recapitulates many of the key features of subclinical HSV-2 infection in women but seems to be more limited, as virus shedding was undetectable more than 40 days after the last virus inoculation.IMPORTANCE Herpes simplex virus 2 (HSV-2) infects nearly 500 million persons globally, with an estimated 21 million incident cases each year, making it one of the most common sexually transmitted infections (STIs). HSV-2 is associated with increased human immunodeficiency virus type 1 (HIV-1) acquisition, and this risk does not decline with the use of antiherpes drugs. As initial acquisition of both HIV and HSV-2 infections is subclinical, study of the initial molecular interactions of the two agents requires an animal model. We found that HSV-2 can infect RM after vaginal inoculation, establish latency in the nervous system, and spontaneously reactivate; these features mimic some of the key features of HSV-2 infection in women. RM may provide an animal model to develop strategies to prevent HSV-2 acquisition and reactivation.
Published: 2019

45. Effectiveness of the Ad26.COV2.S vaccine in health-care workers in South Africa (the Sisonke study): results from a single-arm, open-label, phase 3B, implementation study

Author: Brumskine, William, Naicker, Nivashnee, Makhaza, Disebo, Naicker, Vimla, Naidoo, Logashvari, Spooner, Elizabeth, van Nieuwenhuizen, Elane, Mngadi, Kathryn, Nchabeleng, Maphoshane, Innes, James Craig, Gill, Katherine, Petrick, Friedrich Georg, Barnabas, Shaun, Badal-Faesen, Sharlaa, Kassim, Sheetal, Mahoney, Scott Hayden, Lazarus, Erica, Nana, Anusha, Maboa, Rebone Molobane, Kotze, Philip, Lombaard, Johan, Malan, Daniel Rudolf, Kotze, Sheena, Mohlala, Phuthi, Ward, Amy, Meintjes, Graeme, Urbach, Dorothea, Patel, Faeezah, Diacon, Andreas, Ahmed, Khatija, Grobbelaar, Coert, Mda, Pamela, Dubula, Thozama, Luabeya, Angelique, Mamba, Musawenkosi Bhekithemba, Burgess, Lesley, Dawson, Rodney, Bekker, Linda-Gail, Garrett, Nigel, Goga, Ameena, Fairall, Lara, Reddy, Tarylee, Yende-Zuma, Nonhlanhla, Kassanjee, Reshma, Collie, Shirley, Sanne, Ian, Boulle, Andrew, Seocharan, Ishen, Engelbrecht, Imke, Davies, Mary-Ann, Champion, Jared, Chen, Tommy, Bennett, Sarah, Mametja, Selaelo, Semenya, Mabatlo, Moultrie, Harry, de Oliveira, Tulio, Lessells, Richard John, Cohen, Cheryl, Jassat, Waasila, Groome, Michelle, Von Gottberg, Anne, Le Roux, Engelbert, Khuto, Kentse, Barouch, Dan, Mahomed, Hassan, Wolmarans, Milani, Rousseau, Petro, Bradshaw, Debbie, Mulder, Michelle, Opie, Jessica, Louw, Vernon, Jacobson, Barry, Rowji, Pradeep, Peter, Jonny G, Takalani, Azwi, Odhiambo, Jackline, Mayat, Fatima, Takuva, Simbarashe, Corey, Lawrence, and Gray, Glenda E
Published: 2022
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46. How Immunocompromised Hosts Were Left Behind in the Quest to Control the COVID-19 Pandemic.

Author: Boeckh, Michael, Pergam, Steven A, Limaye, Ajit P, Englund, Janet, Corey, Lawrence, and Hill, Joshua A
Subjects: THERAPEUTIC use of immunoglobulins, THERAPEUTIC use of monoclonal antibodies, IMMUNIZATION, IMMUNOCOMPROMISED patients, HUMAN research subjects, CLINICAL trials, COVID-19 vaccines, IMMUNE system, ANTIVIRAL agents, VACCINE immunogenicity, DRUG interactions, COVID-19, COVID-19 pandemic, IMMUNITY, PHARMACODYNAMICS
Abstract: The immunocompromised population was disproportionately affected by the severe acute respiratory syndrome coronavirus 2 pandemic. However, these individuals were largely excluded from clinical trials of vaccines, monoclonal antibodies, and small molecule antivirals. Although the community of scientists, clinical researchers, and funding agencies have proven that these therapeutics can be made and tested in record time, extending this progress to vulnerable and medically complex individuals from the start has been a missed opportunity. Here, we advocate that it is paramount to plan for future pandemics by investing in specific clinical trial infrastructure for the immunocompromised population to be prepared when the need arises. [ABSTRACT FROM AUTHOR]
Published: 2024
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47. Counterfactual estimation of efficacy against placebo for novel PrEP agents using external trial data: example of injectable cabotegravir and oral PrEP in women

Author: Donnell, Deborah, Gao, Fei, Hughes, James P., Hanscom, Brett, Corey, Lawrence, Cohen, Myron S., Edupuganti, Srilatha, Mgodi, Nyaradzo, Rees, Helen, Baeten, Jared M., Gray, Glenda, Bekker, Linda‐Gail, Hosseinipour, Mina, and Delany‐Moretlwe, Sinead
Subjects: Women -- Health aspects, HIV infection -- Prevention, Company business management, Health
Abstract: : Introduction: Multiple antiretroviral agents have demonstrated efficacy for human immunodeficiency virus (HIV) pre‐exposure prophylaxis (PrEP). As a result, clinical trials of novel agents have transitioned from placebo‐ to active‐controlled designs; however, active‐controlled trials do not provide an estimate of efficacy versus no use of PrEP. Counterfactual placebo comparisons using other data sources could be employed to provide this information. Methods: We compared the active‐controlled study (HPTN 084) of injectable cabotegravir (CAB‐LA) versus daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) among women from seven countries in Africa to three external, contemporaneous randomized HIV prevention trials from which we constructed counterfactual placebo estimates. We used direct standardization via analysis weights to achieve the same distribution of person‐years between the external study and HPTN 084, across strata predictive of HIV risk (country and selected risk covariates). We estimated prevention efficacy against a counterfactual placebo to provide information on the use of CAB‐LA and FTC/TDF compared to no intervention. We compared the counterfactual placebo findings for FTC/TDF to previous placebo‐controlled trials, adjusted for observed adherence to daily pills. Results: Distribution of age and baseline prevalence of gonorrhoea and chlamydia were similar among matched counterfactual placebo and observed HPTN 084 arms after standardization. Counterfactual estimates of CAB‐LA versus placebo in all three settings showed a consistent risk reduction of 93%–94%, with lower bounds of the confidence intervals above 72%. Observed adherence (quantifiable tenofovir in plasma) in HPTN 084 was 54%–56%, and estimated efficacy of daily oral FTC/TDF against a counterfactual placebo was consistent with a predicted risk reduction of 39%–40% for this level of daily pill use. Conclusions: Counterfactual placebo rates of HIV acquisition derived from external trial data in similar locations and time can be used to support estimates of placebo‐based efficacy of a novel HIV prevention agent. External trial data must be standardized to be representative of the clinical trial cohort testing the novel HIV prevention agent, accounting for confounders., INTRODUCTION The daily oral pill pre‐exposure prophylaxis (PrEP) regimen containing emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) reduces human immunodeficiency virus (HIV) by >90%, when used as prescribed [1–3]. While “biological efficacy” of [...]
Published: 2023
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48. 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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49. Supplementary Data 1 from Therapeutic Targeting of TIM-4-L with Engineered T Cells for Acute Myeloid Leukemia

Author: Cieniewicz, Brandon, primary, Oliveira, Edson, primary, Saxton, Mike, primary, Torabi, Damoun, primary, Bhatta, Ankit, primary, Kukutla, Phanidhar, primary, Arballo, Alexander, primary, Yang, Zhuo, primary, Yu, Bi, primary, Fate, Maria, primary, Ning, Hongxiu, primary, Corey, Lawrence, primary, Maiti, Abhishek, primary, and Corey, Daniel, primary
Published: 2024
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50. COVID-19 vaccine efficacy in participants with weakened immune systems from four randomized-controlled trials

Author: Sherman, Amy, primary, Tuan, Jessica, additional, Cantos, Valeria D, additional, Adeyiga, Oladunni, additional, Mahoney, Scott, additional, Ortega-Villa, Ana M, additional, Tillman, Amy, additional, Whitaker, Jennifer, additional, Woodward Davis, Amanda S, additional, Leav, Brett, additional, Hirsch, Ian, additional, Sadoff, Jerald, additional, Dunkle, Lisa M, additional, Gilbert, Peter B, additional, Janes, Holly E, additional, Kublin, James G, additional, Goepfert, Paul A, additional, Kotloff, Karen, additional, Rouphael, Nadine, additional, Falsey, Ann R, additional, El Sahly, Hana M, additional, Sobieszczyk, Magdalena E, additional, Huang, Yunda, additional, Neuzil, Kathleen M, additional, Corey, Lawrence, additional, Grinsztejn, Beatriz, additional, Gray, Glenda, additional, Nason, Martha, additional, Baden, Lindsey R, additional, and Gay, Cynthia L, additional
Published: 2024
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