Bibliographic Details
| Title: |
Protein Dose-Sparing Effect of AS01B Adjuvant in a Randomized Preventive HIV Vaccine Trial of ALVAC-HIV (vCP2438) and Adjuvanted Bivalent Subtype C gp120. |
| Authors: |
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, Scott, Hyman |
| Source: |
Journal of Infectious Diseases; 8/15/2024, Vol. 230 Issue 2, pe405-e415, 11p |
| Subject Terms: |
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] |
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| Database: |
Complementary Index |
