University Hospitals, Case Western Reserve University to study AstraZeneca COVID-19 vaccine candidate

In a phase three clinical trial, University Hospitals (UH) and Case Western Reserve University (CWRU) will study AstraZeneca’s vaccine candidate — AZD1222 — for SARS-CoV-2, the virus that causes COVID-19.

Approximately 80 clinical investigation sites across the country will enroll up to 30,000 participants in the trial, including at UH Cleveland Medical Center. Sponsored by AstraZeneca and funded by the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA), the trial will be randomized and double-blinded. Two doses will be administered four weeks apart.

“UH Cleveland Medical Center is one of 12 sites in North America participating in the HIV Vaccine Trials Network (HVTN), the world’s largest publicly-funded, multi-disciplinary international collaboration facilitating the development of vaccines to prevent HIV/AIDS,” Dr. Grace McComsey, vice president of research and Associate Chief Scientific Officer at UH and a professor at the CWRU School of Medicine, said. “When the COVID-19 pandemic began, HVTN joined with other NIAID-funded clinical research networks to focus on clinical trials related to SARS-CoV-2, thus forming the CoVPN. Because of UH’s involvement in HVTN, many UH physician-scientists have extensive knowledge in vaccine research and hence were natural choices for investigating the efficacy of the potential COVID-19 vaccines.”

AZD1222 was co-created by the University of Oxford and Vaccitech before being licensed to AstraZeneca. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus. The new study will enroll non-pregnant adults older than 18, and its primary endpoint will be prevention of COVID-19 illness after two doses in those that were not previously infected by SARS-CoV-2.

“We are pleased to participate in an additional trial of a COVID-19 vaccine, enhancing options for potential coronavirus prevention,” Dr. Jeffrey Jacobson, attending physician in the Division of Infectious Diseases and HIV Medicine at UH Cleveland Medical Center, said. “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.”