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    Protein Dose-Sparing Effect of AS01B Adjuvant in a Randomized Preventive HIV Vaccine Trial of ALVAC-HIV (vCP2438) and Adjuvanted Bivalent Subtype C gp120.
    (2024-Aug-16) Chirenje ZM; Laher F; Dintwe O; Muyoyeta M; deCamp AC; He Z; Grunenberg N; Laher Omar F; Seaton KE; Polakowski L; Woodward Davis AS; Maganga L; Baden LR; Mayer K; Kalams S; Keefer M; Edupuganti S; Rodriguez B; Frank I; Scott H; Stranix-Chibanda L; Gurunathan S; Koutsoukos M; Van Der Meeren O; DiazGranados CA; Paez C; Andersen-Nissen E; Kublin J; Corey L; Ferrari G; Tomaras G; McElrath MJ; Department of Medicine, University of Rochester, Rochester, NewYork, USA.; SanFrancisco Department of Public Health, San Francisco, California, USA.; Duke Human Vaccine Institute, Duke University Medical Center, Durham, North Carolina, USA.; Faculty of Medicine and Health Science, University of Zimbabwe Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe.; National Institute for Medical Research-Mbeya Medical Research Centre, Mbeya, Tanzania.; Division of Infectious Diseases, Vanderbilt University Medical Center, Nashville, Tennessee, USA.; Beth Israel Deaconess Medical Center, Harvard University, Boston, Massachusetts, USA.; Cape Town HIV Vaccine Trials Network Immunology Laboratory, Cape Town, South Africa.; Department of Obstetrics and Gynecology, University of California San Francisco, San Francisco, California, USA.; Department of Medicine, Emory University, Atlanta, Georgia, USA.; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.; Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.; School of Medicine, University of Pennsylvania, Philadelphia, USA.; GSK, Wavre, Belgium.; GSK, Rixensart, Belgium.; Center for Human Systems Immunology, Duke University School of Medicine, Durham, North Carolina, USA.; Division of Infectious Diseases and HIV Medicine, Department of Medicine, Case Western Reserve University/University Hospitals, Cleveland Medical Center, Cleveland, Ohio, USA.; Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.; Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.; Department of Surgery, Duke University Medical Center, Durham, North Carolina, USA.; The Fenway Institute, Fenway Health, Boston, Massachusetts, USA.; Centre for Infectious Diseases Research in Zambia, Livingstone, Zambia.; Sanofi Pasteur, Swiftwater, Pennsylvania, USA.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    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.