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

向弗雷德里克国家癌症研究实验室(FNLCR)的生物药物开发计划(BDP)提出的这一请求，是为了生产基于HIV的DNA和蛋白质疫苗组件的cGMP。这些临床产品将用于在第一阶段临床试验中测试候选艾滋病毒疫苗的免疫原性和安全性。这些从未在人类身上进行过测试的免疫原包括新型HIV gp160包膜免疫原，其设计目的是将疫苗平台中的抗体干扰降至最低，从而引发对HIV的持久单核细胞记忆反应。具体地说，我们要求cGMP生产： 1)艾滋病毒A/E分支A244∆V1 gp160 DNA疫苗 2)艾滋病毒B亚型A244∆V1 Gag DNA疫苗 3)HIV A/E分支A244gp120蛋白在V1中缺失，并被设计为保持V2的α-螺旋构象(A244∆V1gp120)。

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).