HIV LCMV vaccines

本项目旨在制备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。假设疫苗对人类施用是安全的，并引起对HIV-1的免疫应答。受试者接受LCMV载体疫苗作为单药或作为初免-加强方案的一部分。NIAID疫苗研究中心（VRC）正在开发一种针对三种全球最流行的HIV亚型（进化枝）的新型初免-加强HIV疫苗策略。VRC的HIV初免-加强候选物旨在引发对来自进化枝A、B和C的HIV序列的免疫反应，这些进化枝共同导致全球约90%的HIV感染事件。2004年11月，VRC临床试验中心在NIH临床中心（Bethesda，MD）启动了多分支、多基因重组腺病毒载体5疫苗的I期临床研究（VRC 006），作为开发初免-加强方案的第一步。LCMV产品正在作为第二代载体疫苗进行评估，作为初免-加强方案的一部分，为未来的临床试验做准备。

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 LCMV vectored vaccine either as a single agent or as part of a prime-boost regimen. 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. The LCMV product is being evaluated as a second generation vectored vaccine as part of a prime-boost regimen in preparation for future clinical trials.