HIV Monoclonal Antibody Studies

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This Vaccine Research Center (VRC) Clinical Trials Program (CTP) project is for clinical trials related to passive immunity (monoclonal antibodies) directed against HIV, evaluated in healthy volunteers and HIV-infected volunteers. A brief summary of each study to date follows. VRC 601 (13-I-0189) is the first Phase I dose-escalation study in HIV-infected volunteers of a human monoclonal antibody, identified as VRC-HIVMAB060-00-VP (VRC01), which has broad HIV-1 neutralizing activity and was developed by the VRC/NIAID/NIH. Sci Transl Med. 2015 Dec 23;7(319):319ra206. VRC 602 (14-I-0019) was a Phase 1 dose-escalation study of the safety and pharmacokinetics of human monoclonal antibody VRC01, administered intravenously or subcutaneously to healthy adults. The study initiated in FY14. Clin Exp Immunol. 2015 Dec;182(3):289-301. VRC 606 (16-I-0018) wds the first study of a new generation of highly potent and broadly neutralizing HIV-1 human MAb, VRC01LS, targeted against the HIV-1 CD4 binding site. The study examined safety, tolerability and pharmacokinetics. VRC01LS was being administered to healthy adults by the intravenous and subcutaneous routes. The study was initiated in FY16 and accrual completed in FY17. PLoS Med. 2018 Jan 24;15. VRC 607 (16-I-0147) is the first Phase I single dose study of the safety and virologic effect of monoclonal antibody VRC01LS administered intravenously to HIV-infected adults. VRC01LS is a next generation MAb developed by the VRC to extend the antibody half-life. Accrual is ongoing. VRC 605 (17-I-0030) was a Phase 1 dose-escalation study of the safety and pharmacokinetics of human monoclonal antibody VRC07-523LS administered intravenously or subcutaneously to healthy adults. The study was initiated and accrual completed in FY17. Lancet HIV. 2019 Oct;6(10):e667-e679. VRC 603 (18-I-0030) is the first Phase I dose-escalation study of the safety of AAV8-VRC07 (VRC-HIVAAV070-00-GT) recombinant AAV vector expressing VRC07 HIV-1 neutralizing antibody in antiretroviral treated, HIV-1 infected adults with controlled viremia. Accrual is ongoing. VRC 609 (18-I-0105) is a Phase I dose-escalation study of the safety and pharmacokinetics of human monoclonal antibody, N6LS, administered intravenously or subcutaneously to healthy adults. The study was initiated in FY18 and data analysis is ongoing. VRC 610 (18-I-0113) is a phase I safety and pharmacokinetics study to evaluate human monoclonal antibody 10E8VLS administered alone or concurrently with MAB VRC07-523LS via subcutaneous injection in healthy adults. The study was initiated in FY18 and analysis is ongoing.