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) 的生物制药开发计划 (BDP) 提出的，用于基于 HIV 的 DNA 和蛋白质疫苗成分的 cGMP 生产。这些临床产品将用于在一期临床试验中测试候选艾滋病毒疫苗的免疫原性和安全性。这些免疫原从未在人体中进行过测试，其中包括新型 HIV gp160 包膜免疫原，旨在最大限度地减少疫苗平台中的抗体干扰，从而引发单核细胞对 HIV 的持久记忆反应。具体来说，我们要求 cGMP 生产： 1) HIV 进化枝 A/E A244ΔV1 gp160 DNA 疫苗 2) HIV B 进化枝 A244ΔV1 Gag DNA 疫苗 3) HIV 进化枝 A/E A244 gp120 蛋白在 V1 中删除，并经过改造以维持 V2 的 α 螺旋构象 (A244ΔV1gp120)。