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

作者：Zoe Moodie, Erica Andersen‐Nissen, Nicole Grunenberg, One Dintwe, Faatima Laher Omar, Jia Jin Kee, Linda‐Gail Bekker, Fatima Laher, Nivashnee Naicker, Ilesh Jani, Nyaradzo Mgodi, Portia Hunidzarira, Modulakgota Sebe, Maurine D. Miner, Laura Polakowski, Shelly Ramirez, Michelle Nebergall, Simbarashe Takuva, Lerato Sikhosana, Jack Heptinstall, Kelly E. Seaton, Stephen De Rosa, Carlos A. DiazGranados, Marguerite Koutsoukos, Olivier Van Der Meeren, Susan W. Barnett, Niranjan Kanesa-thasan, James G. Kublin, Georgia D. Tomaras, M. Juliana McElrath, Lawrence Corey, Kathryn Mngadi, Paul Goepfert, on behalf of the HVTN 107 Protocol Team · 发表于：PLoS Medicine · 年份：2024 · DOI：10.1371/journal.pmed.1004360 · 被引用次数：9 · 研究领域：HIV Research and Treatment、HIV/AIDS Research and Interventions、Immunotherapy and Immune Responses

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-HI...