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

Lawrence Corey(Cape Town HVTN Immunology Laboratory / Hutchinson Centre Research Institute of South Africa), Peter B. Gilbert(Cape Town HVTN Immunology Laboratory / Hutchinson Centre Research Institute of South Africa), Michal Juraska(Cape Town HVTN Immunology Laboratory / Hutchinson Centre Research Institute of South Africa), David C. Montefiori(Duke Medical Center), Lynn Morris(National Health Laboratory Service), Shelly Karuna(Cape Town HVTN Immunology Laboratory / Hutchinson Centre Research Institute of South Africa), Srilatha Edupuganti(Emory University), Nyaradzo Mgodi(University of Zimbabwe), Allan C. deCamp(Cape Town HVTN Immunology Laboratory / Hutchinson Centre Research Institute of South Africa), Erika Rudnicki(Cape Town HVTN Immunology Laboratory / Hutchinson Centre Research Institute of South Africa), Yunda Huang(Cape Town HVTN Immunology Laboratory / Hutchinson Centre Research Institute of South Africa), Pedro Gonzáles(Hospital Nacional Dos de Mayo), Robinson Cabello(Asociación Civil Impacta Salud y Educación), Catherine Orrell(Desmond Tutu HIV Foundation), Javier R. Lama(Asociación Civil Impacta Salud y Educación), Fatima Laher(Norwegian Womens Public Health Association), Erica Lazarus(Norwegian Womens Public Health Association), Jorge Sánchez(National University of San Marcos), Ian Frank(Norwegian Womens Public Health Association), Juan Hinojosa(Asociación para la Conservación de la Cuenca Amazónica), Magdalena E. Sobieszczyk(Columbia University Irving Medical Center), Kyle Marshall(Cape Town HVTN Immunology Laboratory / Hutchinson Centre Research Institute of South Africa), Pamela Mukwekwerere(University of Zimbabwe), Joseph Makhema(Norwegian Womens Public Health Association), Lindsey R. Baden(Brigham and Women's Hospital), James I. Mullins(University of Washington), Carolyn Williamson(Norwegian Womens Public Health Association), John Hural(Cape Town HVTN Immunology Laboratory / Hutchinson Centre Research Institute of South Africa), M. Juliana McElrath(Cape Town HVTN Immunology Laboratory / Hutchinson Centre Research Institute of South Africa), Carter Bentley(Cape Town HVTN Immunology Laboratory / Hutchinson Centre Research Institute of South Africa), Simbarashe Takuva(Cape Town HVTN Immunology Laboratory / Hutchinson Centre Research Institute of South Africa), Margarita M. Gomez Lorenzo(Norwegian Womens Public Health Association), David Burns(Norwegian Womens Public Health Association), Nicole Espy(Cape Town HVTN Immunology Laboratory / Hutchinson Centre Research Institute of South Africa), April K. Randhawa(Cape Town HVTN Immunology Laboratory / Hutchinson Centre Research Institute of South Africa), Nidhi Kochar(Cape Town HVTN Immunology Laboratory / Hutchinson Centre Research Institute of South Africa), Estelle Piwowar‐Manning(Johns Hopkins University), Deborah Donnell(Cape Town HVTN Immunology Laboratory / Hutchinson Centre Research Institute of South Africa), Nirupama Sista(Family Health International 360), P. Andrew(Family Health International 360), James G. Kublin(Cape Town HVTN Immunology Laboratory / Hutchinson Centre Research Institute of South Africa), Glenda Gray(South African Medical Research Council), Julie E. Ledgerwood(Norwegian Womens Public Health Association), John R. Mascola(Norwegian Womens Public Health Association), Myron S. Cohen(University of North Carolina at Chapel Hill)
New England Journal of Medicine
March 17, 2021
10.1056/nejmoa2031738
Cited by 530Open Access
Full Text

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.).

Related Papers

No related papers found

Powered by citation graph analysis