Vaccine and Monoclonal Antibody Studies in HIV-infected Subjects

摘要：这项临床研究项目是针对HIV的主动免疫(疫苗)和被动免疫(单抗)相关的临床试验，通过NIH临床中心VRC临床试验计划在HIV感染志愿者身上进行评估。以下是迄今为止每项研究的简要摘要。 VRC 101(06-I-0056)是VRC开发的两种候选HIV-1疫苗的第一阶段治疗研究，并以Prime-Boost方案给予。发表了一份描述结果的手稿：J感染性疾病。2013年6月15日；207(12)：1829-40。 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。一份描述结果的手稿出版了：SCI Transl Med。2015年12月23日；7(319)：319-206。 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。

Summary: This clinical research project is for clinical trials related to active immunity (vaccines) and passive immunity (monoclonal antibodies) directed against HIV that are evaluated in HIV-infected volunteers through clinical trials conducted by the VRC Clinical Trials Program at the NIH Clinical Center. A brief summary of each study to date follows. VRC 101 (06-I-0056) was the first Phase I therapeutic study of two candidate HIV-1 vaccines developed by the VRC and administered in a prime-boost regimen. A manuscript describing results was published: J Infect Dis. 2013 Jun 15;207(12):1829-40. 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. A manuscript describing results was published: Sci Transl Med. 2015 Dec 23;7(319):319ra206. 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.