Vaccine Efficacy of ALVAC-HIV and Bivalent Subtype C gp120-MF59 in Adults.
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Gray Glenda E, Bekker Linda-Gail, Laher Fatima, Malahleha Mookho, Allen Mary, Moodie Zoe, Grunenberg Nicole, Huang Yunda, Grove Doug, Prigmore Brittany, Kee Jia J, Benkeser David, Hural John, Innes Craig, Lazarus Erica, Meintjes Graeme, Naicker Nivashnee, Kalonji Dishiki, Nchabeleng Maphoshane, Sebe Modulakgotla, Singh Nishanta, Kotze Philip, Kassim Sheetal, Dubula Thozama, Naicker Vimla, Brumskine William, Ncayiya Cleon N, Ward Amy M, Garrett Nigel, Kistnasami Girisha, Gaffoor Zakir, Selepe Pearl, Makhoba Philisiwe B, Mathebula Matsontso P, Mda Pamela, Adonis Tania, Mapetla Katlego S, Modibedi Bontle, Philip Tricia, Kobane Gladys, Bentley Carter, Ramirez Shelly, Takuva Simbarashe, Jones Megan, Sikhosana Mpho, Atujuna Millicent, Andrasik Michele, Hejazi Nima S, Puren Adrian, Wiesner Lubbe, Phogat Sanjay, Diaz Granados Carlos, Koutsoukos Marguerite, Van Der Meeren Olivier, Barnett Susan W, Kanesa-Thasan Niranjan, Kublin James G, McElrath M Juliana, Gilbert Peter B, Janes Holly, Corey Lawrence, HVTN 702 Study Team
Аннотация
METHODS: In this phase 2b-3 trial, we randomly assigned 5404 adults without HIV-1 infection to receive the vaccine (2704 participants) or placebo (2700 participants). The vaccine regimen consisted of injections of ALVAC-HIV at months 0 and 1, followed by four booster injections of ALVAC-HIV plus bivalent subtype C gp120-MF59 adjuvant at months 3, 6, 12, and 18. The primary efficacy outcome was the occurrence of HIV-1 infection from randomization to 24 months.
RESULTS: In January 2020, prespecified criteria for nonefficacy were met at an interim analysis; further vaccinations were subsequently halted. The median age of the trial participants was 24 years; 70% of the participants were women. The incidence of adverse events was similar in the vaccine and placebo groups. During the 24-month follow-up, HIV-1 infection was diagnosed in 138 participants in the vaccine group and in 133 in the placebo group (hazard ratio, 1.02; 95% confidence interval, 0.81 to 1.30; P = 0.84).
CONCLUSIONS: The ALVAC-gp120 regimen did not prevent HIV-1 infection among participants in South Africa despite previous evidence of immunogenicity. (HVTN 702 ClinicalTrials.gov number, NCT02968849.).