ANTHRAX VACCINE RESEARCH PROGRAM

这个子项目是许多利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 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年与疾病预防控制中心签订了一项合同协议，以响应国会的研究授权，研究目前使用的已批准炭疽疫苗的安全性和有效性，以防止吸入性炭疽用作生物制剂。 埃默里大学被选为这项人类和NHP临床试验的五个地点之一。该试验的目的是通过确定免疫何时成功发生以及改变疫苗接种途径来减少所需疫苗的数量。 本研究的第二个主要组成部分是对接种疫苗的动物模型（恒河猴）进行气溶胶炭疽孢子攻毒，以支持从人类临床疫苗研究中收集的数据。两个合同地点（亚特兰大埃默里大学耶基斯NPRC和俄亥俄州巴特尔纪念研究所）负责监督研究的各个组成部分。 完成动物攻毒，本研究的数据用于支持AVA人体临床研究的结论。 在报告期间，PI向CDC提交了一份分析NHP试验免疫学结果的最终报告。该项目的所有实验室工作均已完成;当2009年年中揭盲人体临床试验数据时，PI将对其进行分析，以建立连接人体和NHP免疫学数据的桥梁。 埃默里大学和疾病预防控制中心之间关于该项目的动物和实验室部分的合同于2008年12月结束，但该项目的人体临床试验部分将在埃默里大学继续进行，直到2009年底。

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 the approved anthrax vaccine currently in use to protect against inhalational anthrax used as a biological agent. Emory University was selected as one of the five sites for this human and NHP clinical trial. The purpose of the trial has been to reduce the number of vaccines necessary by determining when immunity successfully takes place as well as changing the route of administration of the vaccine. A second principal component of the study was an aerosol anthrax spore challenge of a vaccinated animal model (Rhesus monkeys) performed to support the data collected from a human clinical vaccine study. Two contract sites (Yerkes NPRC, Emory University, Atlanta, and Battelle Memorial Institute, Ohio) have overseen various components of the study. The animal challenge was completed with data from this study being used to support conclusions from the AVA human clinical study. During the reporting period, the PI submitted a final report analyzing the immunological results of the NHP trial to the CDC. All laboratory work on the project has been completed; when the human clinical trial data is unblinded in mid-2009, it will be analyzed by the PI to build a bridge linking the human and NHP immunological data. The contract between Emory and the CDC for the animal and laboratory portion of this project ended in December 2008, but the Human Clinical Trial portion of the project will continue at Emory until the end of 2009.