Introducing the Infectious Diseases Clinical Research Consortium and an associated new consortium leadership group: a clinical trials network encompassing the National Institute of Allergy and Infectious Diseases (NIAID), one of the National Institutes of Health, long-standing Vaccine and Treatment Evaluation Units (VTEUs). NIAID intends to spend approximately $29 million per year for seven years for the VTEU program and its companionship leadership group.
What are VTEUs?
Established in 1962 by NIAID, the VTEUs offer a ready resource for conducting clinical trials of vaccines and treatments for infectious diseases. NIAID offers a map of the VTEU by geographic region. VTEUs have played a key role in the NIAID effort to develop new and improved vaccines and therapies against infectious diseases for over four decades. These units have accumulated deep and extensive vaccine-centric clinical trial expertise—conducting hundreds of clinical trials for which many have directly contributed to vaccine licensure.
Key Value Proposition
VTEUs have an ability to enroll large numbers of volunteers into trials quite rapidly—and expeditiously implement vaccine clinical trial programs in safe, high-quality clinical research site environments. This ability to conduct safe, efficient and rapid-response vaccines contributes to an important vaccine testing infrastructure in America.
Examples: Influenza Vaccine Shortages
Back in 2004, the U.S. faced an unexpected shortage of seasonal flue vaccines. VTEUs were mobilized for large-scale trials to evaluate the seasonal influenza vaccine Fluarix for use in healthy adults in the United States. The trial demonstrated the vaccine’s safety and ability to generate an immune response—ultimately leading to FDA approval—less than a year before the trail commenced.
VTEU Network Overview
The nine VTEUs are located at institutions across the United States. They will conduct Phase 1 through 4 vaccine and treatment trials, including clinical studies in collaboration with industry partners. Depending on the disease or condition, the VTEUs may establish study sites and enroll participants at locations outside the United States. Additionally, sites will have the capacity to conduct human challenge trials—where healthy volunteers are exposed to infection under tightly controlled conditions—of influenza, malaria and other diseases.
Infectious Diseases Clinical Research Consortium—Leadership Group
The consortium leadership group will be headed by co-principal investigators David S. Stephens, M.D., of Emory University, and Kathleen M. Neuzil, M.D., M.P.H., of the University of Maryland School of Medicine. The group will include VTEU investigators as well as scientific experts in infectious diseases who will prioritize candidate vaccines, diagnostics, therapeutics and other interventions to test in clinical trials. To respond to public health emergencies, the leadership group will have the capacity to rapidly organize and initiate clinical trials at the VTEU sites. It also will coordinate activities with VTEU sites implementing specific clinical trials and with scientific staff in the NIAID Division of Microbiology and Infectious Diseases (DMID).
Kathleen M. Neuzil, M.D., M.P.H., of the University of Maryland School of Medicine
David S. Stephens, M.D., of Emory University
Baylor College of Medicine, Houston
Principal Investigator (PI): Hana M. El Sahly, M.D.
Grant number: 1 UM1 AI148575-01
Cincinnati Children’s Hospital Medical Center
PI: Robert Wilson Frenck, Jr., M.D.
Grant number: 1 UM1 AI148372-01
Emory University, Atlanta
PIs: Nadine G. Rouphael, M.D. (contact), Evan J. Anderson, M.D., Carlos del Rio, M.D.
Grant number: 1 UM1 AI148576-01
Kaiser Permanente Washington Health Research Institute, Seattle
PI: Lisa A. Jackson, M.D., M.P.H.
Grant number: 1 UM1 AI148373-01
Saint Louis University, St. Louis, Missouri
PI: Daniel Hoft, M.D., Ph.D.
Grant number: 1 UM1 AI148685-01
University of Maryland School of Medicine
PI: Karen L. Kotloff, M.D.
Grant number: 1 UM1 AI148689-01
University of Rochester, New York
PIs: Ann R. Falsey, M.D. (contact), Angela R. Branche, M.D.
Grant number: 1 UM1 AI148450-01
University of Washington, Seattle
PIs: Anna Wald, M.D., M.P.H. (contact), R. Scott McClelland, M.D., M.P.H.
Grant number: 1 UM1 AI148573-01
Vanderbilt University Medical Center, Nashville, Tennessee
PI: C. Buddy Creech, M.D., M.P.H.
Grant number: 1 UM1 AI148452-01