EFFECT OF IMMUNIZATION WITH THE MRK AD5 HIV-1 GAG VACCINE IN HIV INFECTED

MRK AD5 HIV-1 GAG 疫苗免疫对 HIV 感染者的效果

• 批准号: 7379124
• 负责人: MITCHELL J GOLDMAN
• 金额: $ 2.27万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7379124
• 关键词: EFFECT; IMMUNIZATION; MRK; AD5; HIV

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study has been designed to determine if the immune responses elicited by antiretroviral immunotherapy (ARI) are capable of maintaining viral suppression following interruption of antiretroviral therapy (ART). Following the immunization phase of the study, there will be a 16-week ART interruption phase. Subjects will then enter a follow-up phase during which time they will either continue the interruption or will resume ART. This will be followed by a long-term safety follow-up phase. Subjects will receive a series of three immunizations with the MRK Ad5 HIV-gag vaccine or a placebo. The study duration will be approximately 240 weeks with the main study evaluations being conducted through week 87 with follow-up occurring for approximately 150 additional weeks. The sample size will be 120 subjects with participants being randomized to the vaccine at a 2 to 1 ratio; up to ten subjects are expected to enroll locally.

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中出现。列出的机构是中心的机构，不一定是研究者的机构。本研究旨在确定抗逆转录病毒免疫疗法（ARI）引发的免疫反应是否能够在抗逆转录病毒疗法（ART）中断后维持病毒抑制。研究的免疫阶段之后，将有一个为期 16 周的 ART 中断阶段。然后受试者将进入后续阶段，在此期间他们将继续中断或恢复 ART。接下来将是长期的安全随访阶段。受试者将接受 MRK Ad5 HIV-gag 疫苗或安慰剂的一系列三次免疫接种。研究持续时间约为 240 周，主要研究评估将在第 87 周进行，后续随访将持续约 150 周。样本量为 120 名受试者，参与者以 2 比 1 的比例随机接种疫苗；预计最多十个科目将在当地注册。