Vaccine Treatment Evaluation Units: Infectious Diseases Clinical ResearchConsortium

项目摘要 马里兰大学医学院(UMSOM)疫苗开发和全球卫生中心 (CVD)自1974年以来一直是VTEU的既定站点。VTEU的目标是倡导创新的概念 用于临床研究和实施临床现场方案，以评估疫苗、其他预防性生物制品、 用于治疗和预防传染病的治疗学、诊断学和设备，以及心血管疾病 独一无二地准备完成这一目标。根据目前的VTEU合同，CVD被授予超过18项任务 已有700多人参加，并成功地与国内和国际网站进行了合作。使用 此次申请续签资金，CVD再次集结专家，完成调查 在解决NIAID优先领域的所有必要领域拥有互补的技能集的团队。我们的技术 与能力相辅相成的是对大型合同和计划的有效和成熟的领导；广泛 临床研究经验，包括临床试验在所有发展阶段的表现和人类 挑战研究；NIAID优先领域的深入主题专门知识；在培训方面取得的成就 临床研究的研究员和初级教员；健全和创新的项目管理计划；以及 与领导小组(LG)、NIAID、其他VTEU和其他组织合作的凝聚力强的协作方法 合伙人。我们可以使用最先进的临床和实验室设施，包括两个大型住院病房 在那里进行常规的人类挑战研究。这份提案更详细地描述了我们团队的 能够与LG和NIAID密切合作，快速、经济高效地开发 概念、协议、研究设计和提案计划，并维护灵活的基础设施 灵活应对不断变化的研究重点和公共卫生突发事件，需要大量 志愿者。我们将在新数据可用时整合它们，修改我们的工作以与这些新数据保持一致 数据，并对不断变化的研究优先事项作出快速反应。我们与咨询委员会的广泛参与 解决研究优先事项和公共政策使我们能够带来最高优先事项和最具创新性 向LG提出问题。

Project Summary The University of Maryland School of Medicine (UMSOM) Center for Vaccine Development and Global Health (CVD) has been an established VTEU site since 1974. The goal of the VTEUs is to initiate innovative concepts for clinical research and implement clinical site protocols for evaluating vaccines, other preventive biologics, therapeutics, diagnostics, and devices for the treatment and prevention of infectious diseases, and CVD is uniquely poised to accomplish this goal. Under the current VTEU contract, CVD was awarded over 18 Task Orders, enrolled over 700 participants, and successfully collaborated with national and international sites. With this application for renewed funding, CVD has again assembled an expert and accomplished investigative team with complementary skill sets in all areas necessary to address the NIAID priority areas. Our technical capacities are complemented by effective and proven leadership of large contracts and initiatives; extensive clinical research experience, including performance of clinical trials in all phases of development and human challenge studies; in-depth subject matter expertise in NIAID priority areas; an accomplished record in training fellows and junior faculty in clinical research; a robust and innovative project management plan; and a cohesive, collaborative approach to working with the Leadership Group (LG), NIAID, other VTEUs and other partners. We have access to state-of-the art clinical and laboratory facilities, including two large inpatient units where human challenge studies are routinely conducted. This proposal describes in further detail our team’s ability to work closely and collaboratively with the LG and NIAID to quickly and cost-efficiently develop concepts, protocols, study designs and proposal plans, and to maintain a flexible infrastructure that can respond with agility to evolving research priorities and public health emergencies requiring large numbers of volunteers. We will incorporate new data as they become available, modify our work to align with these new data and respond rapidly to evolving research priorities. Our broad involvement with advisory committees that address research priorities and public policy enables us to bring the highest priority and most innovative questions to the LG.