The Vaccine and Treatment Evaluation Units (VTEUs) are a critical resource for the NIAID Infectious Diseases Clinical Research Consortium to conduct clinical research and trials to evaluate vaccines, preventive biologics, therapeutics, diagnostics, predictive markers, and devices for the treatment and prevention of infectious diseases in people of all ages and risk categories. In December 2019 a novel ?-coronavirus, designated SARS-COV-2, was identified in China as a cause of severe pneumonia with explosive human-to human transmission. Illness due to SARS-COV-2 has designated as COVID19 and symptoms range from none to diffuse pneumonia and respiratory failure. By March 2020, SARS-COV-2infections had been identified in every US state and presently over six million have been infected worldwide with nearly 400,000 deaths including over 100,000 persons in the United States . A hallmark of the VTEU network sites is flexibility and responding to emerging threats and changing NIAID priorities. Clearly, COVID19 is such a threat and UR VTEU will conduct collaborative COVID related research with the necessary scientific, clinical, administrative, and organizational structure to support immunologic and pathogenesis natural history studies, therapeutic trials and phase 1, 2, and 3 vaccine trials. Clinical Trials have been initiated to treat patients hospitalized with moderate to severe COVID19 and participation in the Adaptive Clinical Treatment Trial (ACTT) has been ongoing. The success of ACTT1 which demonstrated beneficial effects of the antiviral, Remdesivir, has been followed by ACTT2 which evaluates the combination of an immunomodulator, Baricitinib, in combination with the antiviral. The UR VTEU participated in ACTT1 and is actively engaged in ACTT2. Follow up trials to refine and improve the treatment of COVID19 are anticipated. Vaccines to prevent infection and ameliorate severe disease have begun in the VTEU network. A phase one trial of Moderna's RNA COVID vaccine has been carried out and plans are underway for 2 large phase 3 efficacy trials to begin summer 2020. Other measures such as monoclonal antibodies to provide passive immunity to vulnerable populations that may not respond well to active immunization are planned. At present the UR VTEU is actively engaged in multiple clinical studies to develop counter measures for the prevention and treatment of CoV-SARs-2 that are critically needed.
The University of Rochester Vaccine and Treatment Evaluation Unit (VTEU) will conduct collaborative COVID related research with the necessary scientific, clinical, administrative, and organizational structure to support immunologic and pathogenesis natural history studies, therapeutic trial and phase 1, 2, and 3 vaccine trials. Measures for the prevention and treatment of CoV-SARs-2 are critically needed.
