Two Randomized Trials of Neutralizing Antibodies to Prevent HIV-1 Acquisition
Author(s)
Peter B. Gilbert
Michal Juraska
David C. Montefiori
Lynn Morris
Shelly Karuna
Srilatha Edupuganti
Nyaradzo Mgodi
Allan C. deCamp
Erika Rudnicki
Yunda Huang
Pedro Gonzáles
Robinson Cabello
Catherine Orrell
Javier R. Lama
Fatima Laher
Erica Lazarus
Jorge Sánchez
Ian Frank
Juan Hinojosa
Magdalena E. Sobieszczyk
Kyle Marshall
Pamela 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 Burns
Nicole Espy
April K. Randhawa
Nidhi Kochar
Estelle Piwowar‐Manning
Deborah Donnell
Nirupama Sista
P. Andrew
James G. Kublin
Glenda Gray
Julie E. Ledgerwood
John R. Mascola
Myron S. Cohen
Date Issued
17 de marzo de 2021
Type
Article
Volume
384
Issue
11
Start Page
1003
End Page
1014
Abstract
BACKGROUND: Whether a broadly neutralizing antibody (bnAb) can be used to prevent human immunodeficiency virus type 1 (HIV-1) acquisition is unclear. METHODS: ) of acquired isolates was measured with the TZM-bl assay. RESULTS: <1 μg per milliliter) per 100 person-years was 0.20 among VRC01 recipients and 0.86 among placebo recipients (estimated prevention efficacy, 75.4%; 95% CI, 45.5 to 88.9). The prevention efficacy against sensitive isolates was similar for each VRC01 dose and trial; VRC01 did not prevent acquisition of other HIV-1 isolates. CONCLUSIONS: VRC01 did not prevent overall HIV-1 acquisition more effectively than placebo, but analyses of VRC01-sensitive HIV-1 isolates provided proof-of-concept that bnAb prophylaxis can be effective. (Supported by the National Institute of Allergy and Infectious Diseases; HVTN 704/HPTN 085 and HVTN 703/HPTN 081 ClinicalTrials.gov numbers, NCT02716675 and NCT02568215.).
Subjects