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Vaccine Efficacy of ALVAC-HIV and Bivalent Subtype C gp120-MF59 in Adults

Authors :
Philip Kotze
Fatima Laher
Mary Allen
Peter B. Gilbert
Jia J. Kee
Dishiki Jenny Kalonji
Carter Bentley
Susan W. Barnett
Tricia Philip
Craig Innes
Adrian Puren
Holly Janes
Millicent Atujuna
Nivashnee Naicker
M. Juliana McElrath
Philisiwe B. Makhoba
Gladys Kobane
Girisha Kistnasami
Katlego S. Mapetla
Zakir Gaffoor
Cleon N. Ncayiya
Sanjay Phogat
Vimla Naicker
Simbarashe Takuva
James G. Kublin
Linda-Gail Bekker
Nima S. Hejazi
David Benkeser
Niranjan Kanesa-thasan
Modulakgotla Sebe
Olivier Van Der Meeren
Yunda Huang
Bontle Modibedi
Pamela Mda
Mookho Malahleha
Mpho Sikhosana
Matsontso Mathebula
Pearl Selepe
Amy Ward
Lawrence Corey
Megan Jones
John Hural
Tania Adonis
Sheetal Kassim
Carlos Diaz Granados
Nicole Grunenberg
Shelly Ramirez
Doug Grove
Maphoshane Nchabeleng
Brittany Prigmore
Graeme Meintjes
Erica Lazarus
William Brumskine
Lubbe Wiesner
Nigel Garrett
Marguerite Koutsoukos
Thozama Dubula
Zoe Moodie
Glenda Gray
Nishanta Singh
Michele P. Andrasik
Source :
The New England journal of medicine. 384(12)
Publication Year :
2021

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 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.).

Details

ISSN :
15334406
Volume :
384
Issue :
12
Database :
OpenAIRE
Journal :
The New England journal of medicine
Accession number :
edsair.doi.dedup.....6fbe0fad196305adb7e7bbb1cc0f70e1