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

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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.