HVTN 060: PHASE I TRIAL

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 主要目标 A部 “评估肌肉注射HIV-1 Gag DNA疫苗的安全性和耐受性 评估肌肉注射HIV-1 Gag DNA疫苗和IL-12 DNA佐剂(递增剂量分别为100微克、500微克和1500微克)的安全性和耐受性 B部分 “为了进一步评估肌肉注射HIV-1 Gag DNA疫苗的安全性和耐受性，在一系列启动程序之后，并用同源质粒加强接种 为了进一步评估肌肉注射HIV-1 Gag DNA疫苗+IL-12 DNA佐剂作为启动序列，然后用同源质粒或HIV CTL MEP/RC529-SE/GM-CSF加强接种的安全性和耐受性 A及B部 为了评估肌肉注射HIV-1 Gag DNA疫苗的免疫原性。将使用干扰素-ELISpot和细胞内细胞因子染色来评估HIV特异性反应。 为了评价肌肉注射HIV-1 Gag DNA疫苗+IL-12 DNA佐剂，然后用同源质粒或HIV CTL MEP/RC529-SE/GM-CSF加强免疫的免疫原性。将使用干扰素-ELISpot和细胞内细胞因子染色来评估HIV特异性应答。 社会影响 “评估参与审判的社会影响

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