A PROBE STUDY OF THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF HUMAN IMMUNO

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。主要的假设是，HIV-1 Gag DNA疫苗总体上是安全的，耐受性良好。具体地说，预计在计划的随访期内不会发生与疫苗相关的严重不良事件。主要目标是评估两种剂量水平(1毫克和5毫克)的HIV-1 Gag DNA疫苗的总体安全性和耐受性，包括与疫苗相关的严重不良反应、局部和全身反应、温度、NAD超出实验室范围。次要目标包括：1)总结在第三次接种HIV-1 Gag DNA疫苗后4周，通过大量培养的CTL和干扰素-γELISPOT检测疫苗在所有组的免疫原性。2.)总结该疫苗在所有其他免疫原性时间点上的免疫原性，通过批量培养CTL和干扰素-γ斑点法检测疫苗的免疫原性。3.)总结所有疫苗组在所有免疫原性时间点的GAG抗体反应。4.)目的探讨人类免疫缺陷病毒(HIV-1)Gag DNA感染者MHC(HLA1A2.1)四聚体的检测方法。5.)总结各疫苗组腺病毒中和滴度(GMT)。

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. The primary hypotheses is that the HIV-1 gag DNA vaccine will be generally safe and well tolerated. Specifically, no vaccine-related serious adverse event is expected during the planned follow-up period. The primary objective is to assess the general safety and tolerability of the HIV-1 gag DNA vaccine at two dosage levels (1mg and 5mg), in terms of vaccine-related serious adverse experiences, local and systemic reactions, temperatures, nad out of range laboratory values. Secondary objectives include: 1.) To summarize the immunogenicity of the vaccine in all groups, as measured in bulk culture CTL and IFN-y ELIspot assays 4 weeks following the third dose of HIV-1 gag DNA vaccine. 2.) To summarize the immunogenicity of the vaccine as measured by bulk culture CTL and IFN-y ELI spot at all other immunogenicity time points. 3.) To summarize gag antibody responses in all vaccine groups at all immunogenicity time points. 4.) To explore the MHC (HLA) Type 1 A2.1 Tetramer assay in subjects receiving HIV-1 gag DNA. 5.) To summarize the Adeno5 neutralization titers (GMTs) in all vaccine groups.