HIV Monoclonal Antibody Studies

该疫苗研究中心(VRC)临床试验计划(CTP)项目是针对艾滋病毒的被动免疫(单抗)相关的临床试验，在健康志愿者和艾滋病毒感染志愿者中进行评估。以下是迄今为止每项研究的简要摘要。 VRC 601(13-I-0189)是VRC-HIVMAB060-00-VP(VRC01)单抗在HIV感染志愿者中的第一阶段剂量递增研究，该单抗具有广泛的HIV-1中和活性，由VRC/NIAID/NIH开发。SCI，Transl Med.2015年12月23日；7(319)：319-206。 VRC 602(14-I-0019)是一项人类单抗VRC01的安全性和药代动力学的第一阶段剂量递增研究，给健康成年人静脉或皮下注射。这项研究于2014财年启动。CLIN Exp免疫。2015年12月；182(3)：289-301。 VRC 606(16-I-0018)是针对HIV-1 CD4结合位点的新一代高效和广泛中和HIV-1人单抗VRC01LS的第一项研究。这项研究检查了安全性、耐受性和药代动力学。健康成人静脉注射和皮下注射VRC01LS。这项研究于2016财年启动，应计项目于2017财年完成。PLOS Med.2018年1月24日；15. VRC607(16-I-0147)是第一个对静脉注射单抗VRC01LS用于HIV感染成人的安全性和病毒学效应的I期单剂研究。VRC01LS是VRC为延长抗体半衰期而开发的新一代单抗。分析正在进行中。 VRC605(17-I-0030)是一项人类单抗VRC07-523LS静脉或皮下注射给健康成人的安全性和药代动力学的第一阶段剂量递增研究。这项研究已于2017财年启动并完成应计项目。柳叶刀艾滋病毒。2019年10月；6(10)：e667-e679。 VRC 603(18-I-0030)是关于表达VRC07 HIV-1中和抗体的AAV8-VRC07(VRC-HIVAAV070-00-GT)重组AAV载体在抗逆转录病毒治疗后HIV-1感染的成人受控病毒血症中的安全性的第一阶段剂量递增研究。应计正在进行中。 VRC 609(18-I-0105)是一项对健康成年人静脉或皮下注射人类单抗N6LS的安全性和药代动力学的I期剂量递增研究。这项研究于18财年启动，数据分析正在进行中。 VRC610(18-I-0113)是一项I期安全性和药代动力学研究，旨在评价健康成人皮下注射人单抗10E8VLS或与单抗VRC07-523LS联合应用的安全性和药代动力学。这项研究于18财年启动，分析正在进行中。

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. Analysis 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.