HVTN 054: PHASE I TRIAL

HVTN 054：第一阶段试验

• 批准号: 7731430
• 负责人: PETER Edwin WRIGHT
• 金额: $ 0.26万
• 依托单位: VANDERBILT UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7731430
• 关键词: Adenovirus Vector; Antibodies; Binding; Biological Assay; Computer Retrieval of Information on Scientific Projects Database; Dose; Enzyme-Linked Immunosorbent Assay; Funding; Grant; HIV-1; Immune; Institution; Interferons; Participant; Phase I Clinical Trials; Research; Research Personnel; Resources; Safety; Social Impacts; Source; United States National Institutes of Health; Vaccines; immunogenicity; neutralizing antibody; vector vaccine

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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。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。列出的机构是 对于中心，这不一定是调查员的机构。 安全 “为了表征在较低（<1:12）降低AD5中和抗体的参与者中，在两种升级剂量（1010 PU和1011 PU IM）中的单剂量的安全性和耐受性。 次要目标 免疫原性 通过IFN-？ELISPOT，ICS，ELISA评估HIV-1结合抗体的ELISA评估HIV特异性免疫原性，以及单剂量的腺病毒载体疫苗中和中和抗体测定的中和抗体测定，每种腺病毒载体疫苗在两种升级剂量的升级剂量（1011 PU和1011 PU）中（111 pu）（<111）的参与者（<111）的参与者（<111） AD5的抗体。 “评估研究疫苗诱导的中和抗体的大小。 “评估研究疫苗的中和抗体滴度和HIV-1特异性免疫再生的幅度（IFN-？ELISPOT，ICS和HIV-1中和抗体）之间的关联。 社会影响 “评估试验参与的社会影响。