FILOVIRUS ADENO-BASED VACCINES

丝状病毒腺基疫苗

• 批准号: 8357692
• 负责人: Jean L. Patterson
• 金额: $ 10.81万
• 依托单位: TEXAS BIOMEDICAL RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-05-01 至 2012-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8357692
• 关键词: Adenoviruses; Africa; Animals; Bioterrorism; Blood specimen; Development; Disease; Disease Outbreaks; Dose; Ebola Hemorrhagic Fever; Ebola Vaccines; Ebola virus; Exposure to; Filovirus; Funding; Grant; Human; Immune; Immune response; Immunization; Individual; Infection; Licensing; Licensure; Light; Measures; National Center for Research Resources; Preventive; Primates; Principal Investigator; Public Health; Recombinant DNA; Recurrence; Research; Research Infrastructure; Resources; Risk; Source; Testing; United States Food and Drug Administration; United States National Institutes of Health; Vaccinated; Vaccines; Virus; animal rule; base; clinical application; cost; efficacy trial; human disease; nonhuman primate; prevent; vaccine candidate; vector

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. Primary support for the subproject and the subproject's principal investigator may have been provided by other sources, including other NIH sources. The Total Cost listed for the subproject likely represents the estimated amount of Center infrastructure utilized by the subproject, not direct funding provided by the NCRR grant to the subproject or subproject staff. Ebola virus causes a severe hemorrhagic disease in humans and non-human primates (NHP). In humans, the disease is fatal in up to 90% of infected individuals, depending on the Ebola virus species involved in the outbreak. Currently there are neither licensed vaccines nor therapies to prevent or treat Ebola virus. The usual preventive public health measures cannot be applied in the case of Ebola hemorrhagic fever because the natural reservoir has not been positively identified. In light of the risk of bioterrorism and recurrent Ebola outbreaks in Africa, the development of an effective Ebola virus vaccine is urgently needed. Because traditional human efficacy trials cannot be performed for candidate Ebola virus vaccines, licensure will have to be obtained by the Food and Drug Administration's 'Animal Rule' which requires demonstration of efficacy in nonhuman primates. Significant progress has been made towards developing an Ebola vaccine based on DNA and recombinant adenovirus virus vectors. The objective of this study is to test adeno based Ebola vaccines and immunization strategies in nonhuman primates to identify/define immune correlates of protection. Blood samples will be obtained from animals injected with vaccines for assessment of specific vaccine-induced immune responses. Vaccines and unvaccinated controls will be exposed to a lethal dose of Ebola virus to determine the efficacy of candidate vaccines. Animals vaccinated with candidate vaccines will be protected from exposure to a lethal dose of Ebola virus, whilst unvaccinated controls will succumb to infection. The results obtained from these studies will be important in supporting licensure of an Ebola vaccine for clinical application.

这个子项目是许多利用资源的研究子项目之一 由NIH/NCRR资助的中心拨款提供。子项目的主要支持 而子项目的主要调查员可能是由其他来源提供的， 包括其它NIH来源。 列出的子项目总成本可能 代表子项目使用的中心基础设施的估计数量， 而不是由NCRR赠款提供给子项目或子项目工作人员的直接资金。 埃博拉病毒在人类和非人类灵长类动物（NHP）中引起严重的出血性疾病。 在人类中，该疾病在高达90%的感染者中是致命的，这取决于爆发中涉及的埃博拉病毒种类。 目前，既没有获得许可的疫苗，也没有预防或治疗埃博拉病毒的疗法。 通常的预防性公共卫生措施不能适用于埃博拉出血热，因为尚未明确确定天然宿主。 鉴于生物恐怖主义的风险和非洲反复爆发的埃博拉疫情，迫切需要开发有效的埃博拉病毒疫苗。 由于不能对候选埃博拉病毒疫苗进行传统的人体有效性试验，因此必须通过美国食品和药物管理局的“动物规则”获得许可，该规则要求在非人灵长类动物中证明有效性。 在开发基于DNA和重组腺病毒载体的埃博拉疫苗方面取得了重大进展。 本研究的目的是在非人灵长类动物中测试基于腺病毒的埃博拉疫苗和免疫策略，以识别/定义保护的免疫相关性。 将从注射疫苗的动物中采集血样，用于评估特异性疫苗诱导的免疫应答。 疫苗和未接种疫苗的对照将暴露于致死剂量的埃博拉病毒，以确定候选疫苗的有效性。 接种候选疫苗的动物将受到保护，免于接触致命剂量的埃博拉病毒，而未接种疫苗的对照动物将死于感染。 从这些研究中获得的结果将对支持埃博拉疫苗的临床应用许可非常重要。