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。 炭疽疫苗，吸附(AVA)是目前唯一在美国获得许可的预防人类炭疽的疫苗。AVA的许可方案是皮下注射(SQ)一系列6个主要剂量，然后是每年的加强剂量。为了回应美国军方对疫苗使用的担忧，美国国会在2001财年拨款给疾控中心，用于研究疫苗的有效性和安全性。该炭疽疫苗研究计划(AVRP)的一个主要组成部分是一项为期43个月的人体研究，研究AVA通过不同的给药途径(SQ与IM)和给药方案(多达8剂与少至4剂)引起的免疫原性和反应性。埃默里大学被选为这次人体临床试验的五个地点之一。 根据美国食品和药物管理局(FDA)的建议，这项研究的第二个主要组成部分是对接种动物模型(恒河猴)进行的气雾剂炭疽孢子挑战，以支持从人类临床疫苗研究收集的数据。这种免疫反应-保护关系可以通过预测人类临床研究志愿者根据他们对疫苗的免疫反应而受到保护的可能性来支持人类临床研究。两个合同地点(亚特兰大埃默里大学的耶克斯灵长类中心和俄亥俄州的巴特尔纪念研究所)监督了动物处理中的各个组成部分，包括疫苗接种、标本采集、挑战和安乐死。埃默里疫苗中心的免疫学核心实验室正被合同用于研究人类和动物研究中的免疫反应，并帮助疾控中心在这两个部分之间建立数据桥梁。 然后，将使用建模技术来描述挑战前免疫反应参数与挑战后结果之间的关系。这项研究的数据将用于支持AVA人类临床研究的结论。在过去的一年里，动物研究和人类临床试验都已经结束。对动物数据的分析正在进行中，人类数据正在汇编和准备进行分析。

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. Anthrax Vaccine, Adsorbed (AVA) is currently the only vaccine licensed in the United States for protection against human anthrax. The licensed regimen for AVA is subcutaneous (SQ) administration of a series of 6 primary doses followed by annual booster doses. In response to concerns about the use of the vaccine in the US military, in Fiscal Year 2001 the US Congress appropriated funds to CDC to study the efficacy and safety of the vaccine. A principal component of this Anthrax Vaccine Research Program (AVRP) is a 43-month human study of immunogenicity and reactogenicity elicited by AVA given by different routes of administration (SQ versus IM) and dosing regimens (as many as 8 doses versus as few as 4 doses). Emory University was selected as one of the five sites for this human clinical trial. A second principal component of the study, undertaken at the recommendation of the Food and Drug Administration (FDA), 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. This immune response-protection relationship can be bridged to support the human clinical study by predicting the likelihood that human clinical study volunteers would be protected based on their immune response to the vaccine. Two contract sites (Yerkes Primate Center, Emory University, Atlanta, and Battelle Memorial Institute, Ohio) have overseen various components in the animal handling including vaccination, specimen collection, challenge and euthanasia. The Immunology Core lab of the Emory Vaccine Center is being utilized contractually to study the immunity response in both the human and animal studies, and aid the CDC in bridging data between the two parts. Modeling techniques will then be used to characterize the relationship between pre-challenge immune response parameters and outcomes after challenge. Data from this study will be used to support conclusions from the AVA human clinical study. In the past year, both the animal study and the human clinical trial have concluded. Analysis of the animal data is underway, and human data is being compiled and prepared for analysis.