- 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;
- McElrath, M
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.