Development Of A Multicomponent HIV-1 Recombinant Adenoviral Vector Vaccine

该项目旨在制备GMP质量的研究性HIV疫苗，并完成多组分HIV-1腺病毒载体疫苗临床研究所需的临床前和实验室研究。假设疫苗对人类来说是安全的，并能引发对HIV-1的免疫反应。受试者接种腺载体疫苗，要么作为单一制剂，要么在用质粒DNA疫苗启动后作为增强剂接种。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(CLADE)的新的优质增强艾滋病毒疫苗战略。VRC的HIV Prime-Boost候选方案旨在诱导对来自A、B和C分支的HIV序列的免疫反应，这些序列加在一起导致了全球约90%的艾滋病毒感染事件。2004年11月，VRC临床试验核心在NIH临床中心(马里兰州贝塞斯达)启动了一项多分支、多基因重组腺病毒载体5疫苗的I期临床研究(VRC 006)，作为开发Prime-Boost方案的第一步。自那以后，该产品已在美国和国际上的几个第一阶段和第二阶段临床试验中作为单一药物和DNA主-腺病毒载体增强方案的一部分进行了临床评估。第二阶段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 for clinical studies of a multicomponent HIV-1 adenoviral vector vaccine. The hypothesis is that the vaccine will be safe for human administration and elicit immune responses to HIV-1. Subjects receive adenovector vaccine either as a single agent or as a boost after priming with plasmid DNA vaccines. 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. In November 2004, the VRC Clinical Trials Core launched a Phase I clinical study (VRC 006) of a multiclade, multigene recombinant adenovector 5 vaccine at the NIH Clinical Center (Bethesda, MD) as the first step in developing the prime-boost regimen. This product has since been evaluated clinically as a single agent and as part of a DNA prime-adenovector boost regimen in several Phase 1 and 2 clinical trials in U.S. and international sites. Production of Phase II materials has been completed.