Development And Production Of A Multiclade HIV-1 DNA Plasmid Vaccine

该项目旨在制备GMP质量的研究性艾滋病毒疫苗，并完成开始临床试验所需的临床前和实验室研究。NIAID的疫苗研究中心（VRC）正在开发一种针对全球最流行的三种艾滋病毒亚型（分支）的新型初促型艾滋病毒疫苗策略。VRC的HIV初级增强候选物旨在引发对A、B和C支HIV序列的免疫反应，这三个支共导致全球约90%的HIV感染事件。该产品已在美国和国际上的多个1期和2期临床试验中作为单一药物和DNA引物-腺载体促进方案的一部分在100多个研究对象中进行了临床评估。二期材料的生产已经完成。

This project is designed to prepare a GMP quality investigational HIV vaccine and complete the preclinical and laboratory studies needed to begin a clinical trial. The Vaccine Research Center (VRC), NIAID is developing a novel prime-boost HIV vaccine strategy directed at the three most globally prevalent HIV subtypes (clades). VRC's HIV prime-boost candidate is designed to elicit immune responses to HIV sequences from clades A, B and C which together cause about 90 percent of incident HIV infections around the world. This product has since been evaluated clinically as a single agent and as part of a DNA prime-adenovector boost regimen in over 100 study subjects in several Phase 1 and 2 clinical trials in U.S. and international sites. Production of Phase II materials has been completed.