{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Edupuganti S"],"funding":["NIAID NIH HHS"],"pagination":["671-679"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC8397466"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["87(1)"],"pubmed_abstract":["<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 fol"],"journal":["Journal of acquired immune deficiency syndromes (1999)"],"pubmed_title":["Feasibility and Successful Enrollment in a Proof-of-Concept HIV Prevention Trial of VRC01, a Broadly Neutralizing HIV-1 Monoclonal Antibody."],"pmcid":["PMC8397466"],"funding_grant_id":["P30 AI050410","U01 AI068614","U01 AI068635","UM1 AI069534","U01 AI068618","UM1 AI068635","P30 AI045008","U01 AI068619","UM1 AI068614","UM1 AI069470","UM1 AI068619","UM1 AI068618"],"pubmed_authors":["Rudnicki E","Andrew P","Karg C","Ledgerwood J","Edupuganti S","Greene E","Karuna ST","Gallardo-Cartagena JA","HVTN 704/HPTN 085 study group","Lucas J","Miner MD","Frank I","Cohen MS","Hural J","Gilbert PB","Mgodi N","Corey L","Kochar N","deCamp A","Anderson PL","De La Grecca R","Broder GB","Anderson M","Gomez Lorenzo MM","Tindale I","Sobieszczyk M","Burns D","Mascola JR","Gonzales P"],"additional_accession":[]},"is_claimable":false,"name":"Feasibility and Successful Enrollment in a Proof-of-Concept HIV Prevention Trial of VRC01, a Broadly Neutralizing HIV-1 Monoclonal Antibody.","description":"<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 fol","dates":{"release":"2021-01-01T00:00:00Z","publication":"2021 May","modification":"2026-05-31T06:06:21.63Z","creation":"2025-02-19T01:55:25.874Z"},"accession":"S-EPMC8397466","cross_references":{"pubmed":["33587505"],"doi":["10.1097/QAI.0000000000002639","10.1097/qai.0000000000002639"]}}