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: 9161763
• 负责人: Julie E. Ledgerwood
• 金额: $ 77.47万
• 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/9161763
• 关键词: Active immunity; Adverse effects; Anti-Retroviral Agents; Antibodies; Clinical; Clinical Research; Clinical Trials; Conduct Clinical Trials; Dose; Goals; HIV; HIV Infections; HIV-1; 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; programs; 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.

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。