Two Randomized Trials of Neutralizing Antibodies to Prevent HIV-1 Acquisition
Lawrence Corey, 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
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.).