CGMP MANUFACTURE OF TWO HIV DNA VACCINES AND ONE HIV PROTEIN VACCINE COMPONENT

这是向弗雷德里克国家癌症研究实验室（FNLCR）生物制药开发计划（BDP）提出的关于基于hiv的DNA和蛋白质疫苗成分的cGMP生产的请求。这些临床产品将在一期临床试验中用于测试HIV候选疫苗的免疫原性和安全性。这些免疫原从未在人体中进行过测试，包括新型HIV gp160包膜免疫原，其设计目的是最大限度地减少疫苗平台中的抗体干扰，从而引发对HIV的长期单核细胞记忆反应。具体来说，我们要求cGMP生产：

This request to Biopharmaceutical Development Program (BDP) at the Frederick National Laboratory for Cancer Research (FNLCR) for the cGMP manufacture of HIV-based DNA and protein vaccine components. These clinical products will be used to test the immunogenicity and safety of HIV vaccine candidates in a phase I clinical trial. These immunogens, never tested in humans, include novel HIV gp160 envelope immunogens engineered to minimize antibody interference in a vaccine platform that elicits long lasting monocytes memory responses to HIV. Specifically, we are requesting the cGMP production of: 1) HIV clade A/E A244∆V1 gp160 DNA vaccine 2) HIV clade B A244∆V1 Gag DNA vaccine 3) HIV clade A/E A244 gp120 protein deleted in V1 and engineered to maintain V2 in an α-helix conformation (A244∆V1gp120).