作者
Lawrence Corey, Peter B Gilbert, Michal Juraska, David C Montefiori, Lynn Morris, Shelly T Karuna, Srilatha Edupuganti, Nyaradzo M Mgodi, Allan C Decamp, Erika Rudnicki, Yunda Huang, Pedro Gonzales, Robinson Cabello, Catherine Orrell, Javier R Lama, Fatima Laher, Erica M Lazarus, Jorge Sanchez, Ian Frank, Juan Hinojosa, Magdalena E Sobieszczyk, Kyle E Marshall, Pamela G Mukwekwerere, Joseph Makhema, Lindsey R Baden, James I Mullins, Carolyn Williamson, John Hural, M Juliana McElrath, Carter Bentley, Simbarashe Takuva, Margarita M Gomez Lorenzo, David N Burns, Nicole Espy, April K Randhawa, Nidhi Kochar, Estelle Piwowar-Manning, Deborah J Donnell, Nirupama Sista, Philip Andrew, James G Kublin, Glenda Gray, Julie E Ledgerwood, John R Mascola, Myron S Cohen
发表日期
2021/3/18
期刊
New England Journal of Medicine
卷号
384
期号
11
页码范围
1003-1014
出版商
Massachusetts Medical Society
简介
Background
Whether a broadly neutralizing antibody (bnAb) can be used to prevent human immunodeficiency virus type 1 (HIV-1) acquisition is unclear.
Methods
We enrolled at-risk cisgender men and transgender persons in the Americas and Europe in the HVTN 704/HPTN 085 trial and at-risk women in sub-Saharan Africa in the HVTN 703/HPTN 081 trial. Participants were randomly assigned to receive, every 8 weeks, infusions of a bnAb (VRC01) at a dose of either 10 or 30 mg per kilogram (low-dose group and high-dose group, respectively) or placebo, for 10 infusions in total. HIV-1 testing was performed every 4 weeks. The VRC01 80% inhibitory concentration (IC80) of acquired isolates was measured with the TZM-bl assay.
Results
Adverse events were similar in number and severity among the treatment groups within each trial. Among the 2699 participants in HVTN 704/HPTN 085, HIV-1 infection …
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L Corey, PB Gilbert, M Juraska, DC Montefiori, L Morris… - New England Journal of Medicine, 2021