HVTN 054: PHASE I TRIAL

HVTN 054：第一阶段试验

• 批准号: 7375687
• 负责人: PETER Edwin WRIGHT
• 金额: $ 14.34万
• 依托单位: VANDERBILT UNIVERSITY
• 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/7375687
• 关键词: HVTN; 054; PHASE; TRIAL

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. Safety " To characterize the safety and tolerability of a single dose of the adenoviral vector vaccine delivered at each of two escalating doses (1010 PU and 1011 PU IM) in participants with low (<1:12) titers of pre-existing Ad5 neutralizing antibodies. Secondary objectives Immunogenicity " To evaluate the HIV-specific immunogenicity, as assessed by IFN-? ELISpot, ICS, ELISA for HIV-1-binding antibodies, and neutralizing antibody assays, of a single dose of the adenoviral vector vaccine delivered at each of two escalating doses (1010 PU and 1011 PU IM) in participants with low (<1:12) titers of pre-existing neutralizing antibodies to Ad5. " Assess the magnitude of Ad5 neutralizing antibodies induced by the study vaccine. " Assess the association between post-vaccine Ad5 neutralizing antibody titer and magnitude of HIV-1-specific immune reponses (IFN-? ELISpot, ICS, and HIV-1 neutralizing antibodies) induced by the study vaccine. Social impacts " To evaluate the social impacts of trial participation.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子弹和调查员（PI）可能已经从其他NIH来源获得了主要资金，因此可以在其他清晰的条目中代表。列出的机构适用于该中心，这不一定是调查员的机构。安全”以表征在两个不断升级的剂量（1010 PU和1011 PU IM）中，单剂量的腺病毒载体疫苗的安全性和耐受性在低（<1:12）的参与者中，预先存在AD5中和抗体，以评估次要的抗体。 ELISPOT，ICS，ELISA，用于HIV-1结合抗体以及中和抗体测定，以低（<1:12）剂量（<1:12）的参与者的两种升级剂量（1010 PU和1011 PU IM）中的每一种中的每种腺病毒载体疫苗（<1011 PU和1011 PU IM）传递。 “评估研究疫苗诱导的中和抗体的幅度。”评估疫苗后AD5中和中和的抗体滴度与HIV-1特异性免疫再生的大小（IFN-？ELISPOT，ICS，ICS和HIV-1中和HIV-1中和抗体）诱导的研究疫苗诱导的抗体。社会影响”，以评估试验参与的社会影响。