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

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。子项目和研究者（PI）可能从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。主要假设是HIV-1 gag DNA疫苗通常是安全的，耐受性良好。具体而言，在计划的随访期内，预计不会发生疫苗相关严重不良事件。主要目的是评估两种剂量水平（1 mg和5 mg）的HIV-1 gag DNA疫苗的一般安全性和耐受性，包括疫苗相关的严重不良反应、局部和全身反应、体温和超出范围的实验室值。次要目标包括：1.）总结所有组中疫苗的免疫原性，如在第三剂HIV-1 gag DNA疫苗后4周在大量培养物CTL和IFN-γ ELIspot试验中测量的。2.）的情况。总结在所有其他免疫原性时间点通过原液培养物CTL和IFN-γ ELI斑点测定的疫苗免疫原性。3.）第三章总结所有免疫原性时间点所有疫苗组的gag抗体应答。4.）探索接受HIV-1 gag DNA的受试者中的MHC（HLA）1型A2.1四聚体检测。5.）总结所有疫苗组中的Adeno 5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.