HVTN 057: 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。子项目及 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 " 评价两次或三次剂量的4.0 mg HIV-1 DNA疫苗，随后1 x 1010病毒颗粒单位的重组腺病毒载体疫苗加强免疫的安全性和耐受性。 次要目的 " 评价两剂或三剂4.0 mg HIV-1 DNA疫苗联合重组腺病毒载体疫苗加强（1 x 1010病毒颗粒单位）后的细胞和体液免疫应答频率。接种后2周的细胞免疫原性将通过IFN-？ELISpot测定和细胞内细胞因子染色（ICS）。将通过结合和中和抗体试验评估疫苗接种后4周的体液免疫原性。 "

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. "