Vaccine and Treatment Evaluation Units

项目概要/摘要 目前由NIAID资助的位于埃默里大学的疫苗和治疗评估单位（VTEU）是 理想地定位于执行以下使命： 传染病临床研究联盟（IDCRC） . 埃默里大学VTEU由埃默里大学丰富的科学环境支持，有许多协同赠款和各种 涵盖IDCRC所有科学优先领域的专题研究中心。埃默里VTEU基础设施依赖于 两个临床研究中心，共16，000平方英尺的临床，实验室和药房空间和83 教职员工。在过去十年中，作为一个受资助的VTEU，我们已经进行了51个VTEU协议， 担任25项试验的负责人，为17项研究进行终点分析，并发表了22篇高影响力论文。 我们招募了约3，000名参与者，其中55%为女性，37%来自不同种族和民族背景 留存率约为93%。凭借其灵活的基础设施，埃默里VTEU展示了激增能力， 通过优先分配资金资源，为大流行性流感、寨卡病毒、埃博拉病毒和生物防御工作做出贡献， 人员配置。埃默里VTEU将通过加强我们与 格鲁吉亚临床和转化科学联盟，并与著名的埃默里国际合作 在特定协议的基础上。此外，到目前为止，我们的VTEU已经培训了28名研究员和初级教师。 我们将在我们取得的重大成就的基础上，通过实施以下措施来推进IDCRC的使命 具体目标如下： 1.让广泛的埃默里大学科学家参与建立和新出现的传染病 IDCRC核心科学中的疾病，包括概念生成和方案开发。 2.利用我们独特而多样化的人口和最先进的研究基础设施， 实施IDCRC科学的所有组成部分，包括研究实施，数据质量控制和 保证程序、数据管理以及良好临床、实验室和药房规范。 3.优化我们的运营灵活性，以进一步增强我们提供激增能力的能力， 新出现的传染病和大流行病应对措施。 4.扩大我们的辅导能力，并增加早期阶段的职业发展机会 疫苗学、传染病诊断、治疗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.