CLEVELAND — University Hospitals (UH) and Case Western Reserve University (CWRU) announced earlier Thursday that UH Cleveland Medical Center has been selected as a clinical trial site for a vaccine study against SARS-CoV-2.
The Phase 3 global study of AZD1222, the investigational vaccine, is sponsored by AstraZeneca and funded by the National Institute of Allergy and Infectious Diseased (NIAID), a branch of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response.
UH will be one of approximately 80 clinical investigational sites across the U.S. that will be studying AZD1222, which will collectively enroll up to 30,000 participants.
"We are pleased to be bringing our community another potential tool in our fight against the coronavirus," said Daniel I. Simon, MD, Chief Clinical & Scientific Officer and President, UH Cleveland Medical Center and the Herman K. Hellerstein Professor of Medicine at the CWRU School of Medicine. "Since the beginning of the pandemic, UH physician-scientists and caregivers have worked tirelessly to secure a range of options for our patients related to the testing, treatment and prevention of COVID-19. In fact, UH currently has more than 130 interventional and observational clinical studies underway to gain understanding of the pathogenesis of COVID-19 as well as the impact and outcome of various therapeutic treatment options."
AZD1222 was co-invented by the University of Oxford and Vaccitech and then licensed to AstraZeneca. Based on a weakened version of a common cold virus, it uses a replication-deficient chimpanzee viral vector that causes infections in chimps and contains the genetic material of the SARS-CoV-2 virus spike protein. Once vaccinated, the surface spike protein is produced and the body's immune system is able to attack the SARS-CoV-2 virus if later detected in the body.
"We are pleased to participate in an additional trial of a COVID-19 vaccine, enhancing options for potential coronavirus prevention," said principal investigator Jeffrey Jacobson, MD, attending physician in the Division of Infectious Diseases and HIV Medicine at UH Cleveland Medical Center and Professor of Medicine at CWRU School of Medicine. "Recently, the U.S. FDA had paused this trial in the U.S.; however, the FDA along with the Data and Safety Monitoring Board have carefully reviewed all the data from both the COVID-19 vaccine trial and all other trials using this type of vaccine and felt it was safe to continue the trial."
The trial has been approved by UH's Institutional Review Board and is expected to begin enrolling study participants as early as next week.
