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. Primary Aims ' To evaluate the safety and tolerability of two or three doses of 4.0 mg of an HIV-1 DNA vaccine followed by 1 x 1010 viral particle units of a recombinant adenoviral vector vaccine boost. Secondary Aims ' To evaluate the frequency of cellular and humoral immune responses to two or three doses of 4.0 mg of an HIV-1 DNA vaccine administered in combination with a recombinant adenoviral vector vaccine boost at 1 x 1010 viral particle units. Cellular immunogenicity at 2 weeks post vaccination will be assessed by IFN-? ELISpot assay and intracellular cytokine staining (ICS). Humoral immunogenicity at 4 weeks post vaccination will be assessed by binding and neutralizing antibody assays. ' To compare the HIV-1-specific immune responses (as assessed by IFN-? ELISpot, ICS, ELISA, and HIV-1 neutralizing antibody) following Ad5 boost in participants receiving 2 vs 3 doses of DNA in HVTN 052. ' To compare the HIV-1-specific immune responses (as assessed by IFN-? ELISpot, ICS, ELISA, and HIV-1 neutralizing antibody) following Ad5 boost to HIV-1-specific immune responses prior to Ad5 boost. ' To characterize the magnitude and breadth (defined as response to individual peptide pools representing the vaccine inserts and other cross-clade responses) of the vaccine-induced HIV-specific T-cell responses as measured by the IFN-? ELISpot and ICS assays. To assess the effect of pre-boost Ad5 neutralizing antibody titer on post-boost HIV-1-specific T-cell response frequencies and HIV-1 neutralizing antibody titer. ' To assess the effect of pre-boost HIV-specific cellular immunity on post-boost HIV-specific cellular immunity as measured by IFN-? ELISpot and ICS. ' To evaluate the social impacts of trial participation
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