Vaccine and Monoclonal Antibody Studies in HIV-infected Subjects

HIV 感染者的疫苗和单克隆抗体研究

• 批准号: 9353052
• 负责人: Julie E. Ledgerwood
• 金额: $ 107.47万
• 依托单位: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9353052
• 关键词: Active immunity; Adult; Adverse effects; Anti-Retroviral Agents; Antibodies; Clinical; Clinical Research; Clinical Trials; Conduct Clinical Trials; Dose; Goals; HIV; HIV Infections; HIV-1; Half-Life; Immune response; Immunotherapeutic agent; Infection; Infection Control; Manuscripts; Medication Management; Monoclonal Antibodies; National Institute of Allergy and Infectious Disease; Passive Immunity; Phase; Prevention; Publishing; Regimen; Research Project Grants; Therapeutic Studies; United States National Institutes of Health; Vaccines; base; human monoclonal antibodies; method development; next generation; programs; safety study; vaccine candidate; volunteer

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.

摘要：本临床研究项目是针对HIV的主动免疫（疫苗）和被动免疫（单克隆抗体）相关的临床试验，通过由美国国立卫生研究院临床中心VRC临床试验项目进行的临床试验，在感染HIV的志愿者中进行评估。以下是迄今为止每项研究的简要总结。