作者
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 Sebe, Nishanta 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
发表日期
2021/3/25
期刊
New England Journal of Medicine
卷号
384
期号
12
页码范围
1089-1100
出版商
Massachusetts Medical Society
简介
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 …
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GE Gray, LG Bekker, F Laher, M Malahleha, M Allen… - New England Journal of Medicine, 2021