ANTHRAX VACCINE RESEARCH PROGRAM

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 埃默里大学、埃默里疫苗中心和耶克斯国家灵长类动物研究中心于2000年与疾控中心签订了一项合同协议，以回应国会关于研究吸附炭疽疫苗(AVA)的安全性和有效性的授权，AVA是目前美国唯一获得批准的用于预防炭疽感染的炭疽疫苗。埃默里大学被选为进行这项人类临床试验的五个地点之一，以及在非人类灵长类动物(NHP)上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疫苗接种的次数是否可以从18个月内的6次注射减少到6个月内的3-4次；(B)通过测量免疫细胞功能的几个参数来衡量体外保护的相关性。NHP研究的目的是研究：(A)AVA疫苗接种后的免疫保护相关性，在该疫苗中，使用人类AVA剂量或该剂量的几种稀释剂之一对恒河猴进行免疫；(B)评估在暴露于200倍致命剂量的炭疽芽胞喷雾剂后对炭疽感染的保护作用。 该项目的所有实验室工作已于2009年第三季度完成，人体临床试验数据已解盲。

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.