Rutgers New Jersey Medical School Clinical Research Center at University Hospital was selected as a site in the Phase 3 Moderna COVID Vaccine study. NJMS is one of only two New Jersey sites participating. The clinical trial is a public-private partnership between the National Institutes of Health and Moderna.
The trial will evaluate efficacy, safety and ability to provoke an immune response
The trial, coined the COVE Study, is set to begin this month and continue until October, 2022. It is expected to enroll 30,000 participants at approximately 90 sites across the United States.
The messenger RNA (mRNA) vaccine, which has shown promise in a recent study published in The New England Journal of Medicine, was developed to prevent COVID-19 in adults for up to two years. The third phase of the randomized clinical trial will evaluate the drug’s efficacy, safety and ability to provoke an immune response.
“As one of the many National Institute of Health-funded sites trusted to partake in this significant trial, we’re excited to be part of the forefront of efforts helping to fight the COVID-19 pandemic,” said Shobha Swaminathan, MD, Principal Investigator at NJMS CRC, and Medical Director of the Infectious Diseases Practice at University Hopspital.
Essex County is one of the areas hardest hit by COVID-19 with the highest number of deaths in New Jersey. Target populations will include those at increased risk for getting infected with SARS-CoV-2 such as healthcare workers, first responders, persons over the age of 65 years, and those with underlying health conditions.
The vaccine is a lipid nanoparticle-encapsulated nucleoside modified messenger RNA (mRNA)-based vaccine that encodes the SARS-CoV-2spike (S) glycoprotein. This protein is critical for entry of the virus into the host cell and is the primary vaccine target for this and many other vaccines in development. The phase 1 study results that were published in the New England Journal of Medicine showed that vaccine elicited immune responses in all participants and no safety concerns were identified. The phase two study is ongoing.
The trial has been reviewed by the U.S. Food and Drug Administration and is aligned with FDA guidance on clinical trial design for COVID-19 vaccine studies. The trial data will be reviewed by an independent board organized by the National Institutes of Health. Additional information for this and other prevention efforts can be found at https://www.coronaviruspreventionnetwork.org/
The trial’s sponsors and collaborators include Moderna, the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority, and the National Institute of Allergy and Infectious Diseases, within the NIH.