Extended Stability Program Testing of Two Adenoviral HIV Vaccine Candidates

两种候选腺病毒 HIV 疫苗的扩展稳定性计划测试

• 批准号: 10710026
• 负责人: JESSICA EYLER
• 金额: $ 22.99万
• 依托单位: PAXVAX, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-16 至 2023-09-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10710026
• 关键词: Adenovirus Vector; Biological Assay; Clinical Trials; Contracts; HIV vaccine; Mediation; Protocols documentation; Services; Testing; programs; vaccine candidate

The purpose of this contract is to extend the Stability programs of two adenoviral-vectored HIV vaccine candidates currently being tested in clinical trials. The required services include performing defined, established assays for testing of the product stability as negotiated with the FDA. The contract will support the stability of these two HIV vaccine candidates using pre-approved stability protocols and tests per ICH guidance and pre-approved protocols.

该合同的目的是扩展两种腺病毒载体 HIV 候选疫苗的稳定性计划 目前正在临床试验中进行测试。所需的服务包括按照与 FDA 的协商，执行定义的、既定的产品稳定性检测方法。该合同将使用预先批准的稳定性方案以及根据 ICH 指南和预先批准的方案进行的测试来支持这两种 HIV 候选疫苗的稳定性。