This proposal is for continuation of support for a Vaccine Treatment and Evaluation Unit (VTEU) at Baylor College of Medicine (BCM) and is in response to RFA-AI-18-046. The BCM VTEU will serve as the focal point for clinical research within the Infectious Diseases Clinical Research Consortium (IDCRC), composed of the VTEUs, Leadership Group (LG) and the National Institutes of Allergy and Infectious Diseases (NIAID). The BCM team consists of investigators, administrators, nurses, physician's assistants (PAs), pharmacists, laboratory technicians and support personnel who are highly qualified to perform research to better understand, treat, prevent and control infectious diseases (ID), to perform focused epidemiological studies, and to respond to public health emergencies. The BCM VTEU investigators will utilize their clinical experience and communications/interactions with the larger community of research experts to identify and bring forth clinical research concepts for discussion and review within the IDCRC. In their role within the LG and as directed by the LG policies, the BCM investigators will assist in reviewing and prioritizing all submitted concepts, and then participate in the design and development of approved concepts into protocols for implementation within the VTEU network. During the process of developing a protocol, the BCM VTEU investigators will assess the suitability of the BCM site to perform the study, and/or will help identify additional sites using an existing large network of collaborators, if directed by the LG. If the BCM VTEU is selected as a study site, the BCM VTEU team will implement the study per Good Clinical Practices and applicable regulations, and assist with data analysis and reporting/publication. BCM investigators will leverage their collaborative network to identify and onboard additional sites needed to conduct large scale studies, and provide geographical and population diversity to meet NIAID's priority research area of emerging ID. The project's Specific Aims are: 1. Conduct clinical research addressing clinical vaccine development (Phases 1-4 clinical trials), human experimental infections (influenza and enteric viruses), and evaluations in patients with respiratory, gastrointestinal and sexually transmitted infections; 2. Provide infrastructure and capabilities for rapid expansion to evaluate vaccines/therapeutics for pathogens of public health importance; and 3. Provide mentoring to junior investigators with interest in vaccines & ID clinical research.

Public Health Relevance

Infectious diseases are a major cause of human suffering and mortality in the US and worldwide. The Vaccine and Treatment Evaluation Unit at Baylor College of Medicine offers a cadre of experts in clinical research who will perform clinical vaccine development research against a variety of pathogens, and studies in patients with respiratory, gastrointestinal and sexually transmitted infections. Results from these studies will improve the scientific community's understanding of these diseases and inform public health policies.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project with Complex Structure Cooperative Agreement (UM1)
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Special Emphasis Panel (ZAI1)
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Lee, Marina
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Baylor College of Medicine
Internal Medicine/Medicine
Schools of Medicine
United States
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