HVTN 057: PHASE I TRIAL

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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. 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. "