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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. 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, Sexually Transmitted Infections, Biotechnology, Infectious Diseases, Clinical Research, Prevention, Vaccine Related, Clinical Trials and Supportive Activities, Immunization, HIV/AIDS, Vaccine Related (AIDS), 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

3. Risk Factors Associated with HIV Acquisition in Males Participating in HIV Vaccine Efficacy Trials in South Africa

Author

Malahleha, Mookho, Laher, Fatima, Dilraj, Athmanundh, Smith, Philip, Gray, Glenda E., Grove, Doug, Odhiambo, Jackline A., Andrasik, Michele P., Grunenberg, Nicole A., Moodie, Zoe, Huang, Yunda, Borate, Bhavesh R., Gillespie, Kevin M., Allen, Mary, Atujuna, Millicent, Singh, Nishanta, Kalonji, Dishiki, Meintjes, Graeme, Kotze, Phillip, Bekker, Linda-Gail, and Janes, Holly

Published
2023
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4. 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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5. 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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6. 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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7. 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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8. 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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9. Safety and immunogenicity of an AS03-adjuvanted SARS-CoV-2 recombinant protein vaccine (CoV2 preS dTM) in healthy adults: interim findings from a phase 2, randomised, dose-finding, multicentre study

Author

Sridhar, Saranya, Joaquin, Arnel, Bonaparte, Matthew I, Bueso, Agustin, Chabanon, Anne-Laure, Chen, Aiying, Chicz, Roman M, Diemert, David, Essink, Brandon J, Fu, Bo, Grunenberg, Nicole A, Janosczyk, Helene, Keefer, Michael C, Rivera M, Doris M, Meng, Ya, Michael, Nelson L, Munsiff, Sonal S, Ogbuagu, Onyema, Raabe, Vanessa N, Severance, Randall, Rivas, Enrique, Romanyak, Natalya, Rouphael, Nadine G, Schuerman, Lode, Sher, Lawrence D, Walsh, Stephen R, White, Judith, von Barbier, Dalia, de Bruyn, Guy, Canter, Richard, Grillet, Marie-Helene, Keshtkar-Jahromi, Maryam, Koutsoukos, Marguerite, Lopez, Denise, Masotti, Roger, Mendoza, Sandra, Moreau, Catherine, Ceregido, Maria Angeles, Ramirez, Shelly, Said, Ansoyta, Tavares-Da-Silva, Fernanda, Shi, Jiayuan, Tong, Tina, Treanor, John, Diazgranados, Carlos A, and Savarino, Stephen

Published
2022
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10. Factors associated with reactogenicity to an investigational HIV vaccine regimen in HIV vaccine trials network 702

Author

Chihana, Rachel, primary, Jin Kee, Jia, additional, Moodie, Zoe, additional, Huang, Yunda, additional, Janes, Holly, additional, Dadabhai, Sufia, additional, Roxby, Alison C., additional, Allen, Mary, additional, Kassim, Sheetal, additional, Naicker, Vimla, additional, Innes, Craig, additional, Naicker, Nivashnee, additional, Dubula, Thozama, additional, Grunenberg, Nicole, additional, Malahleha, Mookho, additional, Kublin, James G., additional, Bekker, Linda-Gail, additional, Gray, Glenda, additional, Kumwenda, Johnstone, additional, and Laher, Fatima, additional

Published
2024
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11. Non-HIV Vaccine-Induced Immune Responses as Potential Baseline Immunogenicity Predictors of ALVAC-HIV and AIDSVAX B/E-Induced Immune Responses.

Author

Huang, Ying, Alam, Shomoita, Andersen-Nissen, Erica, Carpp, Lindsay N., Dintwe, One B., Flach, Britta S., Grunenberg, Nicole, Laher, Fatima, De Rosa, Stephen C., Ferrari, Guido, Innes, Craig, Bekker, Linda-Gail, Kublin, James G., McElrath, M. Juliana, Tomaras, Georgia D., Gray, Glenda E., and Gilbert, Peter B.

Subjects
HEPATITIS associated antigen, AIDS vaccines, TETANUS vaccines, HEPATITIS B vaccines, VACCINE effectiveness, HEPATITIS B virus
Abstract

Identifying correlations between immune responses elicited via HIV and non-HIV vaccines could aid the search for correlates of HIV protection and increase statistical power in HIV vaccine-efficacy trial designs. An exploratory objective of the HVTN 097 phase 1b trial was to assess whether immune responses [focusing on those supported as correlates of risk (CoR) of HIV acquisition] induced via the RV144 pox-prime HIV vaccine regimen correlated with those induced via tetanus toxoid (TT) and/or hepatitis B virus (HBV) vaccines. We measured TT-specific and HBV-specific IgG-binding antibody responses and TT-specific and HBV-specific CD4+ T-cell responses at multiple time points in HVTN 097 participants, and we assessed their correlations at peak time points with HIV vaccine (ALVAC-HIV and AIDSVAX B/E)-induced responses. Four correlations were significant [false discovery rate-adjusted p-value (FDR) ≤ 0.2]. Three of these four were with IgG-binding antibody responses to TT measured one month after TT receipt, with the strongest and most significant correlation [rho = 0.368 (95% CI: 0.096, 0.588; p = 0.008; FDR = 0.137)] being with IgG-binding antibody responses to MN gp120 gDneg (B protein boost) measured two weeks after the second ALVAC-HIV and AIDSVAX B/E boost. The fourth significant correlation [(rho = 0.361; 95% CI: 0.049, 0.609; p = 0.021; FDR = 0.137)] was between CD4+ T-cell responses to a hepatitis B surface antigen peptide pool, measured 2 weeks after the third HBV vaccination, and IgG-binding antibody responses to gp70BCaseAV1V2 (B V1V2 immune correlate), measured two weeks after the second ALVAC-HIV and AIDSVAX B/E boost. These moderate correlations imply that either vaccine, TT or HBV, could potentially provide a moderately useful immunogenicity predictor for the ALVAC-HIV and AIDSVAX B/E HIV vaccine regimen. [ABSTRACT FROM AUTHOR]

Published
2024
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12. 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 Mike, Laher, Fatima, Dintwe, One, Muyoyeta, Monde, deCamp, Allan C, He, Zonglin, Grunenberg, Nicole, Omar, Faatima Laher, Seaton, Kelly E, Polakowski, Laura, Davis, Amanda S Woodward, Maganga, Lucas, Baden, Lindsey R, Mayer, Kenneth, Kalams, Spyros, Keefer, Michael, Edupuganti, Srilatha, Rodriguez, Benigno, Frank, Ian, and Scott, Hyman

Subjects
CLINICAL trial registries, HIV-1 glycoprotein 120, VACCINE trials, HIV, AIDS 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. [ABSTRACT FROM AUTHOR]

Published
2024
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13. Safety and Immunogenicity of a DNA Vaccine With Subtype C gp120 Protein Adjuvanted With MF59 or AS01 B : A Phase 1/2a HIV-1 Vaccine Trial.

Author

Garrett, Nigel, Dintwe, One, Monaco, Cynthia L., Jones, Megan, Seaton, Kelly E., Church, E. Chandler, Grunenberg, Nicole, Hutter, Julia, deCamp, Allan, Huang, Yunda, Lu, Huiyin, Mann, Philipp, Robinson, Samuel T., Heptinstall, Jack, Jensen, Ryan L., Pantaleo, Giuseppe, Ding, Song, Koutsoukos, Marguerite, Hosseinipour, Mina C., and Van Der Meeren, Olivier

Published
2024
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14. A HIV-1 Gp41 Peptide-Liposome Vaccine Elicits Neutralizing Epitope-Targeted Antibody Responses in Healthy Individuals

Author

Erdmann, Nathan B., primary, Williams, Wilton B, additional, Walsh, Stephen R., additional, Grunenberg, Nicole, additional, Edlefsen, Paul T., additional, Goepfert, Paul A., additional, Cain, Derek W., additional, Cohen, Kristen W., additional, Maenza, Janine, additional, Mayer, Kenneth H., additional, Tieu, Hong Van, additional, Sobieszczyk, Magdalena E., additional, Swann, Edith, additional, Lu, Helen, additional, De Rosa, Stephen C., additional, Sagawa, Zachary, additional, Moody, M. Anthony, additional, Fox, Christopher B., additional, Ferrari, Guido, additional, Edwards, R. J., additional, Acharya, Priyamvada, additional, Alam, S. Munir, additional, Parks, Robert, additional, Barr, Margaret, additional, Tomaras, Georgia D., additional, Montefiori, David C., additional, Gilbert, Peter B., additional, McElrath, M. Juliana, additional, Corey, Lawrence, additional, Haynes, Barton F., additional, and Baden, Lindsey R., additional

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

Published
2024
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16. Efficacy of Messenger RNA–1273 Against Severe Acute Respiratory Syndrome Coronavirus 2 Acquisition in Young Adults From March to December 2021

Author

Stephenson, Kathryn E, primary, Marcelin, Jasmine R, additional, Pettifor, Audrey E, additional, Janes, Holly, additional, Brown, Elizabeth, additional, Neradilek, Moni, additional, Yen, Catherine, additional, Andriesen, Jessica, additional, Grunenberg, Nicole, additional, Espy, Nicole, additional, Trahey, Meg, additional, Fischer, Rebecca S B, additional, DeSouza, Christopher A, additional, Shisler, Joanna L, additional, Connick, Elizabeth, additional, Houpt, Eric R, additional, Chu, Helen Y, additional, McCulloh, Russel J, additional, Becker-Dreps, Sylvia, additional, Vielot, Nadja A, additional, Kalbaugh, Corey A, additional, Cherabuddi, Kartik, additional, Krueger, Karen M, additional, Rosenberg, Molly, additional, Greenberg, Richard N, additional, Joaquin, Arnel, additional, Immergluck, Lilly Cheng, additional, Corey, Lawrence, additional, and Kublin, James G, additional

Published
2023
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17. 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

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

Published
2023
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18. 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 Mike, primary, Laher, Fatima, additional, Dintwe, One, additional, Muyoyeta, Monde, additional, deCamp, Allan C, additional, He, Zonglin, additional, Grunenberg, Nicole, additional, Laher Omar, Faatima, additional, Seaton, Kelly E, additional, Polakowski, Laura, additional, Woodward Davis, Amanda S, additional, Maganga, Lucas, additional, Baden, Lindsey R, additional, Mayer, Kenneth, additional, Kalams, Spyros, additional, Keefer, Michael, additional, Edupuganti, Srilatha, additional, Rodriguez, Benigno, additional, Frank, Ian, additional, Scott, Hyman, additional, Stranix-Chibanda, Lynda, additional, Gurunathan, Sanjay, additional, Koutsoukos, Marguerite, additional, Van Der Meeren, Olivier, additional, DiazGranados, Carlos A, additional, Paez, Carmen, additional, Andersen-Nissen, Erica, additional, Kublin, James, additional, Corey, Lawrence, additional, Ferrari, Guido, additional, Tomaras, Georgia, additional, and McElrath, M Juliana, additional

Published
2023
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19. Efficacy of a monovalent (D614) SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant in adults: a phase 3, multi-country study

Author

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

Published
2023
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21. Analysis of the HIV Vaccine Trials Network 702 Phase 2b–3 HIV-1 Vaccine Trial in South Africa Assessing RV144 Antibody and T-Cell Correlates of HIV-1 Acquisition Risk

Author

Moodie, Zoe, primary, Dintwe, One, additional, Sawant, Sheetal, additional, Grove, Doug, additional, Huang, Yunda, additional, Janes, Holly, additional, Heptinstall, Jack, additional, Omar, Faatima Laher, additional, Cohen, Kristen, additional, De Rosa, Stephen C, additional, Zhang, Lu, additional, Yates, Nicole L, additional, Sarzotti-Kelsoe, Marcella, additional, Seaton, Kelly E, additional, Laher, Fatima, additional, Bekker, Linda Gail, additional, Malahleha, Mookho, additional, Innes, Craig, additional, Kassim, Sheetal, additional, Naicker, Nivashnee, additional, Govender, Vaneshree, additional, Sebe, Modulakgotla, additional, Singh, Nishanta, additional, Kotze, Philip, additional, Lazarus, Erica, additional, Nchabeleng, Maphoshane, additional, Ward, Amy M, additional, Brumskine, William, additional, Dubula, Thozama, additional, Randhawa, April K, additional, Grunenberg, Nicole, additional, Hural, John, additional, Kee, Jia Jin, additional, Benkeser, David, additional, Jin, Yutong, additional, Carpp, Lindsay N, additional, Allen, Mary, additional, D’Souza, Patricia, additional, Tartaglia, James, additional, DiazGranados, Carlos A, additional, Koutsoukos, Marguerite, additional, Gilbert, Peter B, additional, Kublin, James G, additional, Corey, Lawrence, additional, Andersen-Nissen, Erica, additional, Gray, Glenda E, additional, Tomaras, Georgia D, additional, and McElrath, M Juliana, additional

Published
2022
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