Vaccine and Treatment Evaluation Units

项目摘要/摘要 目前，设在埃默里大学的NIAID资助的疫苗和治疗评估单位(VTEU)是 非常适合执行的使命 传染病临床研究联盟(IDCRC) 。 埃默里VTEU得到了埃默里丰富的科学环境的支持，提供了大量的协同拨款和各种 专题研究中心，涵盖IDCRC的所有科学优先领域。Emory VTEU基础设施依赖于 两个临床研究场地，总共有16,000平方英尺的临床、实验室和药房空间，以及83 教职员工。在过去的十年里，作为一个资助的VTEU，我们实施了51项VTEU议定书， 在25项试验中担任牵头，在17项研究中进行终点分析，并发表了22篇高影响力的论文。 我们招募了大约3,000名参与者，其中55%是女性，37%来自不同的种族和民族背景 保留率为93%。凭借其灵活的基础设施，埃默里VTEU展示了激增的能力 通过优先安排资金和资源，为大流行流感、寨卡病毒、埃博拉病毒和生物防御努力做出贡献 人员配备。埃默里VTEU将在目前激增能力的基础上，通过加强我们与 佐治亚州临床和转化科学联盟以及与著名的埃默里国际公司的合作 在特定协议的基础上进行合作。此外，到目前为止，我们的VTEU已经培训了28名研究员和初级教员。 我们将在我们重大成就记录的基础上，通过执行以下措施来推进IDCRC的使命 以下是具体目标： 1.聘请广泛的埃默里科学家，他们在已有的和新出现的传染病方面具有专业知识 国际疾病研究中心核心科学中的疾病，包括概念的产生和方案的制定。 2.利用我们对独特和多样化的人群的访问以及最先进的研究基础设施来 实施国际数据中心科学的所有组成部分，包括进行研究、数据质量控制和 保证程序、数据管理以及良好的临床、实验室和药房实践。 3.优化我们的运营灵活性，以进一步增强我们提供浪涌容量的能力，以应对 新发传染病和大流行应对。 4.扩大辅导能力，增加早期职业发展机会 疫苗学、传染病诊断学、治疗学和预防领域的研究人员。

Project Summary/Abstract The currently NIAID-funded Vaccine and Treatment Evaluation Unit (VTEU) based at Emory University is ideally positioned to implement the mission of the Infectious Diseases Clinical Research Consortium (IDCRC) . The Emory VTEU is supported by Emory's rich scientific milieu with numerous synergistic grants and various thematic research centers covering all IDCRC scientific priority areas. The Emory VTEU infrastructure relies on two clinical research sites with a total of 16,000 square feet of clinical, laboratory, and pharmacy space and 83 faculty members and staff. Over the past decade as a funded VTEU, we have conducted 51 VTEU protocols, served as lead on 25 trials, performed endpoint assays for 17 studies, and published 22 high impact papers. We have enrolled ~3,000 participants, 55% are female and 37% from diverse racial and ethnic backgrounds with a retention rate of ~93%. With its flexible infrastructure, the Emory VTEU demonstrated surge capacity to contribute to pandemic influenza, Zika, Ebola, and biodefense efforts by prioritizing resources in funds and staffing. The Emory VTEU will build on the current surge capacity by strengthening our partnership with the Georgia Clinical and Translational Science Alliance and collaborating with well-established Emory international partners on a protocol-specific basis. Additionally, to date, our VTEU has trained 28 fellows and junior faculty. We will build on our significant record of accomplishment and advance the IDCRC mission by implementing the following specific aims: 1. Engage a broad range of Emory scientists with expertise in established and newly emerging infectious diseases in the core science of the IDCRC including concept generation and protocol development. 2. Leverage our access to a unique and diverse population and state-of-the-art research infrastructure to implement all components of the IDCRC science, including study conduct, data quality control and assurance procedures, data management, and good clinical, laboratory, and pharmacy practices. 3. Optimize our operational flexibility to further enhance our ability to provide surge capacity to address emerging infectious diseases and pandemic response. 4. Expand our mentoring capacity and enhance career development opportunities for early stage investigators in the areas of vaccinology, infectious diseases diagnostics, therapeutics, and prevention.