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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 埃默里大学（Emory University），埃默里疫苗中心和耶克斯国家灵长类动物研究中心（Yerkes National Primate Research Center）于2000年与疾病预防控制中心（CDC）签订了合同协议，以响应国会授权的研究，以研究炭疽疫苗吸附（AVA）（AVA）的安全性和功效，这是目前唯一批准的炭疽病疫苗，目前是美国目前在美国使用的炭疽疫苗。 埃默里大学（Emory University）被选为进行这项人类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。 人类试验的目的是两倍：（a）确定是否可以将AVA疫苗接种的数量从18个月内的6次注射减少到6个月内给予的3-4次注射； （b）通过测量免疫细胞功能的几个参数来测量保护的体外相关。 NHP研究旨在研究：（a）AVA疫苗接种后的免疫相关性，其中恒河猴猕猴使用人AVA剂量或该剂量的几种稀释剂之一进行了免疫； （b）评估暴露于200倍致死剂量炭疽芽孢杆菌孢子的雾化后，防止炭疽感染的保护。 该项目的所有实验室工作都已完成，人类的临床试验数据在2009年第三季度都没有盲目。