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Two Randomized Trials of Neutralizing Antibodies to Prevent HIV-1 Acquisition

Author(s)
Lawrence Corey  
University of the Witwatersrand
Peter B. Gilbert
University of the Witwatersrand
Michal Juraska
University of the Witwatersrand
David C. Montefiori
University of the Witwatersrand
Lynn Morris
National Health Laboratory Service
Shelly Karuna
University of the Witwatersrand
Srilatha Edupuganti
Emory University
Nyaradzo Mgodi
University of Zimbabwe
Allan C. deCamp
University of the Witwatersrand
Erika Rudnicki
University of the Witwatersrand
Yunda Huang
University of the Witwatersrand
Pedro Gonzáles
University of the Witwatersrand
Robinson Cabello
University of the Witwatersrand
Catherine Orrell
University of the Witwatersrand
Javier R. Lama
University of the Witwatersrand
Fatima Laher
University of the Witwatersrand
Erica Lazarus
University of the Witwatersrand
Jorge Sánchez
National University of San Marcos
Ian Frank
University of the Witwatersrand
Juan Hinojosa
University of the Witwatersrand
Magdalena E. Sobieszczyk
University of the Witwatersrand
Kyle Marshall
University of the Witwatersrand
Pamela Mukwekwerere
University of Zimbabwe
Joseph Makhema
University of the Witwatersrand
Lindsey R. Baden
Brigham and Women's Hospital
James I. Mullins
University of the Witwatersrand
Carolyn Williamson
University of the Witwatersrand
John Hural
University of the Witwatersrand
M. Juliana McElrath
University of the Witwatersrand
Carter Bentley
University of the Witwatersrand
Simbarashe Takuva
University of Cape Town
Margarita M. Gomez Lorenzo
University of the Witwatersrand
David Burns
University of the Witwatersrand
Nicole Espy
University of the Witwatersrand
April K. Randhawa
University of the Witwatersrand
Nidhi Kochar
University of the Witwatersrand
Estelle Piwowar‐Manning
National Institutes of Health
Deborah Donnell
University of the Witwatersrand
Nirupama Sista
Family Health International 360
P. Andrew
Family Health International 360
James G. Kublin
University of the Witwatersrand
Glenda Gray
South African Medical Research Council
Julie E. Ledgerwood
University of the Witwatersrand
John R. Mascola
University of the Witwatersrand
Myron S. Cohen
University of North Carolina at Chapel Hill
Date Issued
17 de marzo de 2021
Type
Article
Volume
384
Issue
11
Series/Report No.
New England Journal of Medicine
Start Page
1003
End Page
1014
DOI
10.1056/nejmoa2031738
ISSN
0028-4793
1533-4406
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.).
Keywords

Human immunodeficienc...

Antibody

Virology

Neutralizing antibody...

Virus

Immunology

Medicine

Human immunodeficienc...

Antibody

Virology

Neutralizing antibody...

Virus

Immunology

Medicine

Proof of Concept Stud...

Proof of Concept Stud...

Proof of Concept Stud...

Proof of Concept Stud...

Proof of Concept Stud...

Broadly Neutralizing ...

Broadly Neutralizing ...

Broadly Neutralizing ...

Broadly Neutralizing ...

Broadly Neutralizing ...

Broadly Neutralizing ...

Broadly Neutralizing ...

Broadly Neutralizing ...

Broadly Neutralizing ...

Broadly Neutralizing ...

Adolescent

Adolescent

Adolescent

Adolescent

Adolescent

Adult

Adult

Adult

Adult

Adult

Americas epidemiology...

Americas epidemiology...

Americas epidemiology...

Americas epidemiology...

Americas epidemiology...

Antibodies, Monoclona...

Antibodies, Monoclona...

Antibodies, Monoclona...

Antibodies, Monoclona...

Antibodies, Monoclona...

Antibodies, Monoclona...

Antibodies, Monoclona...

Antibodies, Monoclona...

Antibodies, Monoclona...

Antibodies, Monoclona...

Double-Blind Method

Double-Blind Method

Double-Blind Method

Double-Blind Method

Double-Blind Method

Europe epidemiology

Europe epidemiology

Europe epidemiology

Europe epidemiology

Europe epidemiology

Female

Female

Female

Female

Female

Humans

Humans

Humans

Humans

Humans

Male

Male

Male

Male

Male

HIV Antibodies advers...

HIV Antibodies advers...

HIV Antibodies advers...

HIV Antibodies advers...

HIV Antibodies advers...

HIV Antibodies therap...

HIV Antibodies therap...

HIV Antibodies therap...

HIV Antibodies therap...

HIV Antibodies therap...

HIV-1 drug effects

HIV-1 drug effects

HIV-1 drug effects

HIV-1 drug effects

HIV-1 drug effects

HIV Infections epidem...

HIV Infections epidem...

HIV Infections epidem...

HIV Infections epidem...

HIV Infections epidem...

HIV Infections preven...

HIV Infections preven...

HIV Infections preven...

HIV Infections preven...

HIV Infections preven...

Incidence

Incidence

Incidence

Incidence

Incidence

Africa South of the S...

Africa South of the S...

Africa South of the S...

Africa South of the S...

Africa South of the S...

Young Adult

Young Adult

Young Adult

Young Adult

Young Adult

Life Sciences Immunol...

Health Sciences Medic...

Life Sciences Biochem...

Metrics
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