ANTHRAX VACCINE RESEARCH PROGRAM

炭疽疫苗研究计划

• 批准号: 8172316
• 负责人: ROBERT S MITTLER
• 金额: $ 4.39万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-05-01 至 2011-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8172316
• 关键词: Agreement; Anthrax Vaccines; Anthrax disease; Bacillus anthracis spore; Cell physiology; Centers for Disease Control and Prevention (U.S.); Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Data; Dose; Exposure to; Funding; Grant; Human; Immune; In Vitro; Infection; Injection of therapeutic agent; Institution; Laboratories; Macaca mulatta; Measures; Primates; Research; Research Personnel; Resources; Site; Source; United States National Institutes of Health; Universities; Vaccination; Vaccine Research; Vaccines; Work; aerosolized; design; nonhuman primate; programs; response; safety study

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Emory University, the Emory Vaccine Center, and Yerkes National Primate Research Center entered into a contractual agreement with the CDC in 2000, in response to a Congressional mandate for research to study the safety and efficacy of Anthrax Vaccine Adsorbed (AVA), the only approved anthrax vaccine currently in use in the U.S. to protect against anthrax infection. Emory University was selected as one of five sites to conduct this human clinical trial and one of two sites to carry out a similar study in non-human primates (NHP). The purpose of the human trial was two-fold: (a) to determine whether the number of AVA vaccinations could be reduced from 6 injections over an 18 month period to 3-4 injections given over a 6 month period; (b) to measure in vitro correlates of protection by measuring several parameters of immune cell function. The NHP study was designed to study: (a) immune correlates of protection following AVA vaccination in which groups of Rhesus macaques were immunized using the human AVA dose, or one of several dilutions of that dose; (b) to assess protection against anthrax infection following exposure to an aerosolized 200x lethal dose of Bacillus anthracis spores. All laboratory work on the project has been completed and the human clinical trial data was un-blinded in the third quarter of 2009.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 中心，不一定是研究者的机构。 埃默里大学、埃默里疫苗中心和耶基斯国家灵长类动物研究中心于 2000 年与 CDC 签订了一份合同协议，以响应国会的研究授权，研究炭疽疫苗吸附 (AVA) 的安全性和有效性，这是唯一获得批准的炭疽疫苗。美国目前使用炭疽疫苗来预防炭疽感染。 埃默里大学被选为进行这项人体临床试验的五个地点之一，也是在非人类灵长类动物 (NHP) 中进行类似研究的两个地点之一。 人体试验的目的有两个： (a) 确定 AVA 疫苗接种次数是否可以从 18 个月内注射 6 次减少到 6 个月内注射 3-4 次； (b) 通过测量免疫细胞功能的几个参数来测量体外保护的相关性。 NHP 研究的目的是研究： (a) AVA 疫苗接种后保护的免疫相关性，其中使用人类 AVA 剂量或该剂量的几种稀释液之一对恒河猴群体进行免疫； (b) 评估暴露于雾化的 200 倍致死剂量的炭疽芽孢杆菌孢子后对炭疽感染的保护作用。 该项目的所有实验室工作均已完成，人体临床试验数据已于2009年第三季度揭盲。