Vanderbilt Vaccine and Treatment Evaluation Unit

摘要 这项UM1计划的目标是利用范德比尔特大学卓越的研究基础设施 医疗中心和协作站点(华盛顿大学、匹兹堡大学和大学 来概念化、设计、实施和分析横跨 作为疫苗和治疗评价的各种病原体、传染病和人群 单位(VTEU)。范德比尔特大学医学中心是首批资助的VTEU之一，并在 流感、百日咳、肺炎球菌、天花和疟疾疫苗的关键研究。范德比尔特 VTEU已被证明有能力迅速招收健康人群，包括参加两项NIH- 自2009年以来定向应对流感大流行，以及招募特殊人群的专业知识 例如孕妇、婴儿和儿童、患有潜在医疗合并症的成年人以及 老年人。在目前的申请中，我们扩展了在整个生命周期内招聘的能力，并 跨多种病原体，包括增加性传播感染、疟疾和 在家中进行临床试验访问的新方法。范德比尔特VTEU也 领导了培训下一代疫苗专家和传染病临床试验专家的工作， 包括发展疫苗研究金，研究员和初级教员参与 协议团队和数据安全委员会，并鼓励初级教师的概念发展。 范德比尔特VTEU还致力于与新成立的传染病 疾病领导小组阐明ID研究的优先事项。

ABSTRACT The goal of this UM1 proposal is to use the remarkable research infrastructure at Vanderbilt University Medical Center and collaborating sites (Washington University, University of Pittsburgh, and University of Pennsylvania) to conceptualize, design, implement, and analyze clinical research studies across a wide variety of pathogens, infectious diseases, and populations as a Vaccine and Treatment Evaluation Unit (VTEU). Vanderbilt University Medical Center was among the first VTEUs funded and has led pivotal studies of influenza, pertussis, pneumococcus, smallpox, and malaria vaccines. The Vanderbilt VTEU has a proven capacity to enroll healthy populations rapidly, including participating in two NIH- directed influenza pandemic responses since 2009, as well as expertise enrolling special populations such as pregnant women, infants and children, adults with underlying medical comorbidities, and the elderly. In the current application, we have expanded our ability to recruit across the lifespan and across multiple pathogens, including increased expertise in sexually transmitted infections, malaria, and novel approaches to conducting clinical trial visits in the home setting. The Vanderbilt VTEU has also led efforts to train the next generation of vaccinologists and clinical trial experts in infectious diseases, including the development of a vaccinology fellowship, participation of fellows and junior faculty in protocol teams and data safety committees, and encouraging concept development by junior faculty. The Vanderbilt VTEU is also committed to working collaboratively with the newly formed Infectious Diseases Leadership Group to articulate priorities for ID research.