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.

PROJECT NARRATIVE The goal of the Vanderbilt VTEU is to leverage the robust clinical research environments at four major US institutions to conduct high quality clinical research across the age spectrum and covering multiple infectious diseases. We will focus on our areas of strength, which includes early phase clinical trials of new vaccines and therapeutics; innovative laboratory assays; rapid enrollment, including enrollment of special populations; subject matter expertise across infectious diseases, including bacterial, viral, respiratory, parasitic, and sexually transmitted infections; and training of young vaccinologists and clinical trialists.