Vaccine Treatment Evaluation Units: Infectious Diseases Clinical ResearchConsortium

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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.