ANTHRAX VACCINE RESEARCH PROGRAM

炭疽疫苗研究计划

• 批准号: 7958118
• 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: 2009
• 资助国家: 美国
• 起止时间: 2009-05-01 至 2010-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7958118
• 关键词: Aerosols; Agreement; Animal Model; Animals; Anthrax Vaccines; Anthrax disease; Bacillus anthracis spore; Biological Products; Centers for Disease Control and Prevention (U.S.); Clinical; Clinical Research; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Contracts; Data; Funding; Grant; Human; Immunity; Institutes; Institution; Laboratories; Laboratory Animals; Link; Macaca mulatta; Ohio; Primates; Reporting; Research; Research Personnel; Resources; Route; Site; Source; United States National Institutes of Health; Universities; Vaccinated; Vaccine Research; Vaccines; Work; 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 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.

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。子项目及 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 对于中心来说，它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，以响应国会的一项研究任务，研究目前用于预防感染的已批准炭疽疫苗的安全性和有效性。用作生物制剂的吸入性炭疽。 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的给药途径来减少所需的疫苗数量。 该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击，以支持从人类临床疫苗研究中收集的数据。两个合同地点（Yerkes NPRC、亚特兰大埃默里大学和俄亥俄州巴特尔纪念研究所）监督了该研究的各个部分。 动物挑战已完成，本研究的数据用于支持 AVA 人类临床研究的结论。 报告期内，PI向CDC提交了分析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； 2009年中期人体临床试验数据揭盲后，将由PI进行分析，搭建起连接人体和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到 2009 年底。