Vaccine and Treatment Evaluation Units

疫苗和治疗评估单位

基本信息

批准号：
10406740
负责人：
Nadine Georges Rouphael
金额：
$ 469.92万
依托单位：
EMORY UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-04-26 至 2023-03-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10406740
关键词：
Acquired Immunodeficiency Syndrome Address Adult Anthrax disease Antibiotic Resistance Area Biological Products Categories Centers for Disease Control and Prevention (U.S.)Childhood Clinical Clinical Protocols Clinical Research Clinical Sciences Clinical Trials Clinical Trials Unit Communicable Diseases Communities Complex Consent Databases Dedications Devices Diagnostic Diagnostic Equipment Disease Outcome Drug Kinetics Ebola Elderly Emerging Communicable Diseases End Point Assay Enrollment Ensure Environment Epidemic Ethnic Origin Evaluation Faculty Female Funding Generations Grant HIV Healthcare Systems Human Immunologic Tests Immunologics Immunology Individual Infection Influenza Influenza A Virus, H5N1 Subtype Influenza A Virus, H7N9 Subtype Influenza A virus Infrastructure Institutes Institution International Laboratories Laboratory Research Lead Leadership Malaria Mentors Mission Modeling National Institute of Allergy and Infectious Disease Outpatients Paper Participant Patients Pharmacy facility Phase Population Heterogeneity Positioning Attribute Prevention Procedures Prognostic Marker Protocols documentation Publications Publishing Quality Control Race Research Research Infrastructure Research Personnel Research Training Resources Risk Route Science Scientist Sexually Transmitted Diseases Site Smallpox Specimen Handling Structure Systems Biology Talents Therapeutic Training Training and Education Translational Research Tuberculosis Tularemia Universities Vaccines ZIKA antimicrobial base biodefense career development chikungunya clinical data warehouse clinical research site data management data quality design disease diagnostic enteric pathogen flexibility global health improved outcome member neglected tropical diseases next generation novel pandemic disease pandemic influenza pathogen predictive marker pregnant prevent programs protocol development quality assurance racial and ethnic racial diversity recruit respiratory pathogen response retention rate square foot study population trial design vaccine delivery vaccine evaluation vaccine trial vaccinology

项目摘要

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.

项目摘要/摘要目前由NIAID资助的疫苗和治疗评估单位（VTEU）位于埃默里大学（Emory University）理想的位置可以执行传染病临床研究联盟（IDCRC）。 Emory Vteu得到了埃默里（Emory）丰富的科学环境的支持主题研究中心涵盖了所有IDCRC科学优先领域。 Emory VTEU基础设施依赖两个临床研究地点，共有16,000平方英尺的临床，实验室和药房空间和83 教职员工。在过去的十年中，作为资助的VTEU，我们进行了51条VTEU协议，作为25次试验的铅，进行了17项研究的端点测定，并发表了22份高影响力论文。我们已经招募了约3,000名参与者，55％是女性，而来自不同的种族和种族背景的37％保留率约为93％。 Emory VTEU具有灵活的基础设施，表现出涌现的能力通过优先考虑资金的资源和人员配备。 Emory VTEU将通过加强与我们与佐治亚州的临床和转化科学联盟，并与已建立的Emory International合作特定于协议的合作伙伴。此外，迄今为止，我们的VTEU培训了28名研究员和初级教师。我们将基于我们的重大成就记录，并通过执行IDCRC任务以下具体目的： 1。参与广泛的埃默里科学家，具有专业知识 IDCRC核心科学中的疾病，包括概念生成和协议开发。 2。利用我们进入独特而多样化的人群和最先进的研究基础设施的机会实施IDCRC科学的所有组成部分，包括研究行为，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激增能力解决能力的能力新兴的传染病和大流行反应。 4。扩大我们的指导能力并增强早期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。