HVTN 060: PHASE I TRIAL

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。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 研究中心，而研究中心不一定是研究者所在的机构。 主要目标 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+IL-12 DNA佐剂（递增剂量100 mcg、500 mcg和1500 mcg）肌内给药的安全性和耐受性 B部分 " 进一步评价HIV-1 gag DNA疫苗经同源质粒免疫后肌肉注射的安全性和耐受性 " 进一步评价肌肉注射HIV-1 gag DNA疫苗+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 " 目的评价HIV-1 gag DNA疫苗肌肉注射的免疫原性。将使用IFN-ELISpot和细胞内细胞因子染色评估HIV特异性应答。 " 目的评价HIV-1 gag DNA疫苗与IL-12 DNA佐剂联合肌肉注射免疫小鼠的免疫原性。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 " 评估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