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Cohen, Yehuda Z; Butler, Allison L; Millard, Katrina; Witmer-Pack, Maggi; Levin, Rebeka; Unson-O'Brien, Cecilia; Patel, Roshni; Shimeliovich, Irina; Lorenzi, Julio C C; Horowitz, Jill; Walsh, Stephen R; Lin, Shu; Weiner, Joshua A; Tse, Anna; Sato, Alicia; Bennett, Chelsey; Mayer, Bryan; Seaton, Kelly E; Yates, Nicole L; Baden, Lindsey R; deCamp, Allan C; Ackerman, Margaret E; Seaman, Michael S; Tomaras, Georgia D; Nussenzweig, Michel C; Caskey, Marina
PloS one, 08/2019, Volume: 14, Issue: 8Journal Article
Additional forms of pre-exposure prophylaxis are needed to prevent HIV-1 infection. 3BNC117 and 10-1074 are broadly neutralizing anti-HIV-1 antibodies that target non-overlapping epitopes on the HIV-1 envelope. We investigated the safety, tolerability, pharmacokinetics, and immunogenicity of the intravenous administration of the combination of 3BNC117 and 10-1074 in healthy adults. This randomized, double-blind, placebo-controlled, single center, phase 1 study enrolled healthy adults aged 18-65 years to receive one infusion of 3BNC117 immediately followed by 10-1074 at 10 mg/kg, three infusions of 3BNC117 followed by 10-1074 at 3 mg/kg or 10 mg/kg every 8 weeks, or placebo infusions. The primary outcomes were safety and pharmacokinetics. This trial is registered with ClinicalTrials.gov, number NCT02824536. Twenty-four participants were enrolled in a 3:1 ratio to receive the study products or placebo. The combination of 3BNC117 and 10-1074 was safe and generally well tolerated. There were no serious adverse events considered related to the infusions. The mean elimination half-lives of 3BNC117 and 10-1074 were 16.4 ± 4.6 days and 23.0 ± 5.4 days, respectively, similar to what was observed in previous studies in which each antibody was administered alone. Anti-drug antibody responses were rare and without evidence of related adverse events or impact on elimination kinetics. Single and repeated doses of the combination of 3BNC117 and 10-1074 were well tolerated in healthy adults. These data support the further development of the combination of 3BNC117 and 10-1074 as a long-acting injectable form of pre-exposure prophylaxis for the prevention of HIV-1 infection.
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