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

该请求是向弗雷德里克国家癌症研究实验室（FNLCR）的生物制药开发项目（BDP）提出的，用于生产基于HIV的DNA和蛋白质疫苗组分的cGMP。这些临床产品将在I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测试过，包括新的HIV gp 160包膜免疫原，这些免疫原被设计用于最大限度地减少疫苗平台中的抗体干扰，从而增强单核细胞对HIV的持久记忆反应。具体而言，我们要求cGMP生产： 第一章 HIV A/E A244亚型V1 gp 160 DNA疫苗 （二） HIV进化枝B A244亚型V1 Gag DNA疫苗 第三章 HIV进化枝A/E A244 gp 120蛋白在V1中缺失，并经工程改造以保持V2处于α-螺旋构象（A244 → V1 gp 120）。

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).