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 is 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.
Highlights
NIH-Sponsored Trial of Enterovirus D68 Therapeutic Begins
The National Institutes of Health (NIH) is sponsoring a clinical trial to evaluate the safety of an investigational monoclonal antibody to treat enterovirus D68 (EV-D68), which can cause severe respiratory and neurological diseases such as acute flaccid myelitis (AFM) – similar to polio. Scientists are striving to better understand AFM, which has emerged in the United States with spikes in cases every other year, primarily in the late-summer months over the last decade. The U.S.
Main Areas of Focus
To organize and conduct Phase 1 through 4 vaccine and treatment trials, including clinical studies in collaboration with industry partners
Read more about this network: Infectious Diseases Clinical Research Consortium (IDCRC)