HVTN 060: PHASE I TRIAL

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。所列机构为中心机构，不一定为研究者机构。主要目的A部分“评价HIV-1 gag DNA疫苗肌肉注射的安全性和耐受性“评价HIV-1 gag DNA疫苗加IL-12 DNA佐剂肌肉注射的安全性和耐受性（在100 mcg，500 mcg，和1500 mcg）B部分“进一步评价在用同源质粒进行一系列初免和加强接种后，肌内注射HIV-1 gag DNA疫苗的安全性和耐受性“进一步评价肌内注射HIV-1 gag DNA疫苗加IL-12 DNA佐剂作为初免系列，随后用同源质粒或HIV CTL MEP/RC 529-SE/GM-CSF加强免疫的安全性和耐受性A和B部分“评价肌内注射HIV-1 gag DNA疫苗的免疫原性。将使用IFN-ELISpot和细胞内细胞因子染色评估HIV特异性应答。“评价HIV-1 gag DNA疫苗加IL-12 DNA佐剂作为一个初免系列，随后用同源质粒或HIV CTL MEP/RC 529-SE/GM-CSF加强免疫的免疫原性。将使用IFN-ELISpot和细胞内细胞因子染色评估HIV特异性应答。社会影响“评价参与试验的社会影响

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