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: 9562821
• 负责人: Julie E. Ledgerwood
• 金额: $ 213.25万
• 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/9562821
• 关键词: AIDS prevention; 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; Immunize; Immunotherapeutic agent; Infection; Infection Control; Intravenous; Manuscripts; Medication Management; Monoclonal Antibodies; National Institute of Allergy and Infectious Disease; Passive Immunity; Passive Transfer of Immunity; Periodicity; Phase; Publishing; Regimen; Research Project Grants; Therapeutic Studies; United States National Institutes of Health; Vaccines; human monoclonal antibodies; method development; next generation; programs; safety study; vaccine candidate; virology; 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.

总结：该临床研究项目是针对HIV感染志愿者通过NIH临床中心VRC临床试验项目进行的临床试验进行的针对HIV的主动免疫（疫苗）和被动免疫（单克隆抗体）相关临床试验。 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疫苗的第一个I期治疗研究，并以初免-加强方案给药。 发表了描述结果的手稿：J Infect Dis. 2013年6月15日;207（12）：1829-40。 VRC 601（13-I-0189）是在HIV感染的志愿者中进行的第一项I期剂量递增研究，该研究使用的是一种人单克隆抗体，鉴定为VRC-HIVMAB 060 -00-VP（VRC 01），具有广泛的HIV-1中和活性，由VRC/NIAID/NIH开发。发表了描述结果的手稿：Sci Transl Med. 2015年12月23日;7（319）：319 ra 206。 VRC 607（16-I-0147）是第一项I期单次给药研究，旨在评估单克隆抗体VRC 01 LS静脉注射给药HIV感染成年人的安全性和病毒学效果。VRC 01 LS是VRC开发的新一代单克隆抗体，用于延长抗体半衰期。