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

两种 HIV DNA 疫苗和一种 HIV 蛋白疫苗成分的 CGMP 生产

• 批准号: 10291510
• 负责人: TARA BUTLER
• 金额: $ 1.8万
• 依托单位: LEIDOS BIOMEDICAL RESEARCH, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-25 至 2024-09-24
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10291510
• 关键词: Antibodies; Antigens; Biological Products; Clinical; Cyclic GMP; DNA; DNA Vaccines; Engineering; HIV; HIV Envelope Protein gp120; HIV vaccine; Human; Laboratories; Memory; Molecular Conformation; Phase I Clinical Trials; Program Development; Proteins; Safety; Testing; Vaccines; alpha helix; anticancer research; base; cGMP production; gp160; immunogenicity; monocyte; novel; response; vaccine candidate

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).

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）。