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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 吸附（AVA）的炭疽疫苗目前是美国唯一获得保护人类炭疽的疫苗。 AVA的许可方案是皮下（SQ）给予一系列6个初级剂量，然后是年度助推器剂量。 为了回应对美国军方使用疫苗使用的担忧，在2001财政年度，美国国会将资金拨给了CDC，以研究疫苗的疗效和安全性。 该炭疽疫苗研究计划（AVRP）的主要组成部分是一项43个月的人类研究，对不同的给药途径（SQ versus IM）给出的AVA引起的免疫原性和反应生成性研究（多达8剂剂量，而少于4剂剂量）。 埃默里大学被选为该人类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食品和药物管理局（FDA）的建议进行的，是对疫苗的动物模型（Rhesus Monkeys）的气溶胶炭疽孢子挑战，旨在支持从人类临床疫苗研究中收集的数据。可以通过预测人类临床研究志愿者受到对疫苗的免疫反应来保护人类临床研究的可能性来支持人类临床研究的免疫应答关系。两个合同地点（亚特兰大埃默里大学和俄亥俄州巴特尔纪念研究所的耶克斯灵长类动物中心）负责监督动物处理中的各种组成部分，包括疫苗接种，标本收集，挑战和安乐死。 Emory疫苗中心的免疫学核心实验室正在合同地使用人类和动物研究中的免疫反应，并帮助CDC弥合两部分之间的数据。 然后，建模技术将用于表征挑战前挑战前免疫反应参数与结果之间的关系。 这项研究的数据将用于支持AVA人类临床研究的结论。 在过去的一年中，动物研究和人类临床试验均已得出结论。动物数据的分析正在进行中，正在编译人类数据并准备进行分析。