ANTHRAX VACCINE RESEARCH PROGRAM

炭疽疫苗研究计划

• 批准号: 7715682
• 负责人: ROBERT S MITTLER
• 金额: $ 2.85万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-05-01 至 2009-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7715682
• 关键词: Aerosols; Animal Model; Animals; Anthrax Vaccines; Anthrax disease; Bacillus anthracis spore; Centers for Disease Control and Prevention (U.S.); Clinical; Clinical Research; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Congresses; Contracts; Data; Dose; Euthanasia; Funding; Grant; Human; Immune response; Immunity; Immunology; Institutes; Institution; Licensing; Macaca mulatta; Military Personnel; Modeling; Ohio; Outcome; Primates; Recommendation; Research; Research Personnel; Resources; Route; Series; Site; Source; Techniques; Treatment Protocols; United States; United States Food and Drug Administration; United States National Institutes of Health; Universities; Vaccinated; Vaccination; Vaccine Research; Vaccines; animal data; base; human data; human study; immunogenicity; programs; response; sample collection; subcutaneous; vaccine safety; volunteer

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.

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。子项目和 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。 吸附炭疽疫苗 (AVA) 是目前美国唯一获得许可用于预防人类炭疽的疫苗。 AVA 的许可方案是皮下 (SQ) 施用一系列 6 次初级剂量，然后每年进行加强剂量。 为了回应对美国军队使用该疫苗的担忧，美国国会在2001财年向CDC拨款，用于研究该疫苗的功效和安全性。 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）所引起的免疫原性和反应原性。 埃默里大学被选为此次人体临床试验的五个地点之一。 该研究的第二个主要组成部分是根据美国食品和药物管理局 (FDA) 的建议进行的，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。通过预测人类临床研究志愿者根据对疫苗的免疫反应受到保护的可能性，可以桥接这种免疫反应-保护关系来支持人类临床研究。两个合同地点（亚特兰大埃默里大学耶基斯灵长类动物中心和俄亥俄州巴特尔纪念研究所）负责监督动物处理的各个部分，包括疫苗接种、标本采集、攻击和安乐死。 埃默里疫苗中心的免疫学核心实验室按照合同研究人类和动物研究中的免疫反应，并帮助疾病预防控制中心在这两个部分之间架起数据桥梁。 然后，建模技术将用于表征攻击前免疫反应参数与攻击后结果之间的关系。 这项研究的数据将用于支持 AVA 人体临床研究的结论。 去年，动物研究和人体临床试验均已结束。动物数据的分析正在进行中，人类数据正在汇编和准备用于分析。