Ebola Vaccine Immune Correlates and Mechanism of Protection

埃博拉疫苗免疫相关性和保护机制

• 批准号: 9339104
• 负责人: NANCY J SULLIVAN
• 金额: $ 90.16万
• 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/9339104
• 关键词: Animal Model; Animals; Biological Assay; Cellular Immunity; Clinical Trials; Disease; Ebola Vaccines; Ebola virus; Evaluation; Frankfurt-Marburg Syndrome Virus; Human; Humoral Immunities; Immune; Immune response; Immunity; Infection; Licensure; Pathogenesis; Testing; Vaccine Antigen; Vaccines; Virus; animal rule; design; human subject; immunogenicity; nonhuman primate; response; vaccine efficacy

Use of the FDA Animal Rule for licensure of Ebola and Marburg virus vaccines requires a detailed understanding of vaccine-induced immune response since correlates of immunity will replace efficacy studies that would otherwise be provided to support vaccine licensure. An immune correlate of protection against infection must first be identified in an animal model that reasonably represents disease pathogenesis in humans. Vaccine efficacy is tested in animals, and the immune response that correlates best with survival is identified. Subsequent immunogenicity studies in human subjects are designed to test whether the vaccine can induce similar responses in humans.

将FDA动物规则用于许可埃博拉病毒和马尔堡病毒疫苗需要详细了解疫苗诱导的免疫反应，因为免疫相关性将取代效率研究，否则该研究将提供以支持疫苗许可。 必须在动物模型中首先确定保护感染的免疫相关性，该模型合理地代表了人类疾病发病机理。 在动物中测试了疫苗功效，并确定了与生存最佳相关的免疫反应。 随后在人类受试者中进行的免疫原性研究旨在测试疫苗是否可以诱导人类的相似反应。