Development And Production Of A Multiclade HIV-1 DNA Plasmid Vaccine

多进化枝 HIV-1 DNA 质粒疫苗的开发和生产

• 批准号: 7969859
• 负责人: Richard Schwartz
• 金额: $ 421.29万
• 依托单位: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7969859
• 关键词: Adenovirus Vector; Clinic; Clinical; Clinical Trials; Contracts; DNA; DNA Vaccines; Development; HIV; HIV Infections; HIV vaccine; HIV-1; Human; Immune response; International; Laboratories; Laboratory Study; National Institute of Allergy and Infectious Disease; Phase; Placebos; Plants; Production; Site; Study Subject; Techniques; Testing; Treatment Protocols; Vaccine Production; Vaccine Research; Vaccines; clinical material; design; manufacturing process; novel; pre-clinical; preclinical safety; programs; safety study; vector vaccine

This project is designed to prepare a GMP quality investigational HIV vaccine and complete the preclinical and laboratory studies needed to begin a clinical trial. The Vaccine Research Center (VRC), NIAID is developing a novel prime-boost HIV vaccine strategy directed at the three most globally prevalent HIV subtypes (clades). VRC's HIV prime-boost candidate is designed to elicit immune responses to HIV sequences from clades A, B and C which together cause about 90 percent of incident HIV infections around the world. This product has since been evaluated clinically as a single agent and as part of a DNA prime-adenovector boost regimen in over 100 study subjects in several Phase 1 and 2 clinical trials in U.S. and international sites. Production of Phase II materials has been completed.

该项目旨在准备GMP质量研究的HIV疫苗，并完成开始临床试验所需的临床前和实验室研究。 NIAID疫苗研究中心（VRC）正在开发一种针对全球三种最普遍的HIV亚型（进化枝）的新型原始HIV疫苗策略。 VRC的HIV Prime-bumost候选者旨在引起对进化枝A，B和C的艾滋病毒序列的免疫反应，这些反应共同引起世界各地约90％的事件HIV感染。此后，该产品在临床上作为单一药物进行了评估，并作为在美国和国际地点的几个第1期和2阶段临床试验中的100多个研究对象中的DNA Prime-AdeNovector提升方案的一部分。 II期材料的生产已经完成。