In 2019, NIAID established the Infectious Diseases Clinical Research Consortium, a clinical trials network that encompasses the Institute’s long-standing Vaccine and Treatment Evaluation Units (VTEUs) and a new 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 that will prioritize candidate vaccines, diagnostics, therapeutics and other interventions to test in clinical trials.
The VTEUs are located at institutions across the United States. They 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.
The VTEUs are ready resources to help NIAID respond quickly to public health emergencies, including COVID-19. They are able to rapidly enroll healthy volunteers for NIAID’s mRNA-1273 vaccine study, and enroll COVID-19 patients for the ACTT treatment trial, meeting rigorous scientific standards and generating high quality data. The IDCRC and VTEU investigators are closely coordinating activities to support these critically important clinical trials.
Main Areas of Focus
- To organize and conduct Phase 1 through 4 vaccine and treatment trials, including clinical studies in collaboration with industry partners