The National Institute of Allergy and Infectious Diseases (NIAID), one of the National Institutes of Health (NIH), announced the establishment of the Infectious Diseases Clinical Research Consortium, a clinical trials network that will encompass NIAID’s Vaccine and Treatment Evaluation Units (VTEUs) and create a new consortium leadership group. NIAID intends to provide approximately $29 million per year for seven years for the VTEU program and its companion leadership group.
“For nearly 60 years, NIAID-supported VTEUs have played vital roles in developing new and improved vaccines and treatments for numerous infectious diseases, including influenza, pneumococcal disease and smallpox,” said NIAID Director Anthony S. Fauci, M.D. “This flagship program aligns with NIAID’s dual mission of conducting robust, wide-ranging biomedical research on existing infectious diseases while maintaining readiness to respond to emergent disease threats with the quick design and launch of clinical trials. We anticipate that the addition of a centralized leadership group will further enhance the effectiveness of this time-tested program.”
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).
The nine VTEUs are located at institutions across the U.S. 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 U.S. 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.
“We are excited to announce this new chapter in NIAID’s clinical trials research enterprise,” said DMID Director Emily Erbelding, M.D., M.P.H. “We fully expect that the Infectious Diseases Clinical Research Consortium, DMID’s largest clinical trials network, will continue to accelerate our progress in clinical research of vaccine candidates and other interventions for decades to come.”
