HVTN 060: 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 objectives Part A " To evaluate the safety and tolerability of intramuscular administration of HIV-1 gag DNA vaccine " To evaluate the safety and tolerability of intramuscular administration of HIV-1 gag DNA vaccine plus IL-12 DNA adjuvant (at escalating doses of 100 mcg, 500 mcg, and 1500 mcg) Part B " To further evaluate the safety and tolerability of intramuscular administration of HIV-1 gag DNA vaccine following a priming series and booster vaccinations with homologous plasmid " To further evaluate the safety and tolerability of intramuscular administration of HIV-1 gag DNA vaccine plus IL-12 DNA adjuvant as a priming series followed by booster vaccinations with homologous plasmids or HIV CTL MEP/RC529-SE/GM-CSF Parts A and B " To evaluate the immunogenicity of intramuscular administration of HIV-1 gag DNA vaccine. HIV-specific responses will be assessed using IFN- ELISpot and intracellular cytokine staining. " To evaluate the immunogenicity of intramuscular administration of HIV-1 gag DNA vaccine plus IL-12 DNA adjuvant as a priming series followed by booster vaccinations with homologous plasmids or HIV CTL MEP/RC529-SE/GM-CSF. HIV specific responses will be assessed using IFN- ELISpot and intracellular cytokine staining. Social impacts " To evaluate the social impacts of trial participation