Protein Dose-Sparing Effect of AS01B Adjuvant in a Randomized Preventive HIV Vaccine Trial of ALVAC-HIV (vCP2438) and Adjuvanted Bivalent Subtype C gp120.
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Chirenje Zvavahera Mike, Laher Fatima, Dintwe One, Muyoyeta Monde, deCamp Allan C, He Zonglin, Grunenberg Nicole, Laher Omar Faatima, Seaton Kelly E, Polakowski Laura, Woodward Davis Amanda S, Maganga Lucas, Baden Lindsey R, 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 A, Paez Carmen, Andersen-Nissen Erica, Kublin James, Corey Lawrence, Ferrari Guido, Tomaras Georgia, McElrath M Juliana
Аннотация
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.