Vaccine efficacy of ALVAC-HIV and bivalent subtype C gp120–MF59 in adults

Glenda E. Gray*, Linda Gail Bekker, Fatima Laher, Mookho Malahleha, Mary Allen, Zoe Moodie, Nicole Grunenberg, Yunda Huang, Doug Grove, Brittany Prigmore, Jia J. Kee, David Benkeser, John Hural, Craig Innes, Erica Lazarus, Graeme Meintjes, Nivashnee Naicker, Dishiki Kalonji, Maphoshane Nchabeleng, Modulakgotla SebeNishanta Singh, Philip Kotze, Sheetal Kassim, Thozama Dubula, Vimla Naicker, William Brumskine, Cleon N. Ncayiya, Amy M. Ward, Nigel Garrett, Girisha Kistnasami, Zakir Gaffoor, Pearl Selepe, Philisiwe B. Makhoba, Matsontso P. Mathebula, Pamela Mda, Tania Adonis, Katlego S. Mapetla, Bontle Modibedi, Tricia Philip, Gladys Kobane, Carter Bentley, Shelly Ramirez, Simbarashe Takuva, Megan Jones, Mpho Sikhosana, Millicent Atujuna, Michele Andrasik, Nima S. Hejazi, Adrian Puren, Lubbe Wiesner, Sanjay Phogat, Carlos Diaz Granados, Marguerite Koutsoukos, Olivier van der Meeren, Susan W. Barnett, Niranjan Kanesa-Thasan, James G. Kublin, M. Juliana McElrath, Peter B. Gilbert, Holly Janes, Lawrence Corey

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

10 Citations (Scopus)

Abstract

BACKGROUND A safe, effective vaccine is essential to eradicating human immunodeficiency virus (HIV) infection. A canarypox–protein HIV vaccine regimen (ALVAC-HIV plus AIDSVAX B/E) showed modest efficacy in reducing infection in Thailand. An analogous regimen using HIV-1 subtype C virus showed potent humoral and cellular responses in a phase 1–2a trial in South Africa. Efficacy data and additional safety data were needed for this regimen in a larger population in South Africa. 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 followup, 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.

Original languageEnglish
Pages (from-to)1089-1100
Number of pages12
JournalNew England Journal of Medicine
Volume384
Issue number12
DOIs
Publication statusPublished - 25 Mar 2021
Externally publishedYes

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