biostudies-literatureEdupuganti SNIAID NIH HHS671-679https://www.ebi.ac.uk/biostudies/studies/S-EPMC8397466biostudies-literatureUnknown87(1)<h4>Background</h4>The Antibody-Mediated Prevention trials (HVTN 704/HPTN 085 and HVTN 703/HPTN 081) are the first efficacy trials to evaluate whether VRC01, a broadly neutralizing monoclonal antibody targeting the CD4-binding site of the HIV envelope protein, prevents sexual transmission of HIV-1. HVTN 704/HPTN 085 enrolled 2701 cisgender men and transgender (TG) individuals who have sex with men at 26 sites in Brazil, Peru, Switzerland, and the United States.<h4>Methods</h4>Participants were recruited and retained through early, extensive community engagement. Eligible participants were randomized 1:1:1 to 10 mg/kg or 30 mg/kg of VRC01 or saline placebo. Visits occurred monthly, with intravenous (IV) infusions every 8 weeks over 2 years, for a total of 10 infusions. Participants were folJournal of acquired immune deficiency syndromes (1999)Feasibility and Successful Enrollment in a Proof-of-Concept HIV Prevention Trial of VRC01, a Broadly Neutralizing HIV-1 Monoclonal Antibody.PMC8397466P30 AI050410U01 AI068614U01 AI068635UM1 AI069534U01 AI068618UM1 AI068635P30 AI045008U01 AI068619UM1 AI068614UM1 AI069470UM1 AI068619UM1 AI068618Rudnicki EAndrew PKarg CLedgerwood JEdupuganti SGreene EKaruna STGallardo-Cartagena JAHVTN 704/HPTN 085 study groupLucas JMiner MDFrank ICohen MSHural JGilbert PBMgodi NCorey LKochar NdeCamp AAnderson PLDe La Grecca RBroder GBAnderson MGomez Lorenzo MMTindale ISobieszczyk MBurns DMascola JRGonzales PfalseFeasibility and Successful Enrollment in a Proof-of-Concept HIV Prevention Trial of VRC01, a Broadly Neutralizing HIV-1 Monoclonal Antibody.<h4>Background</h4>The Antibody-Mediated Prevention trials (HVTN 704/HPTN 085 and HVTN 703/HPTN 081) are the first efficacy trials to evaluate whether VRC01, a broadly neutralizing monoclonal antibody targeting the CD4-binding site of the HIV envelope protein, prevents sexual transmission of HIV-1. HVTN 704/HPTN 085 enrolled 2701 cisgender men and transgender (TG) individuals who have sex with men at 26 sites in Brazil, Peru, Switzerland, and the United States.<h4>Methods</h4>Participants were recruited and retained through early, extensive community engagement. Eligible participants were randomized 1:1:1 to 10 mg/kg or 30 mg/kg of VRC01 or saline placebo. Visits occurred monthly, with intravenous (IV) infusions every 8 weeks over 2 years, for a total of 10 infusions. Participants were fol2021-01-01T00:00:00Z2021 May2026-05-31T06:06:21.63Z2025-02-19T01:55:25.874ZS-EPMC83974663358750510.1097/QAI.000000000000263910.1097/qai.0000000000002639