Wake Forest Baptist Health, in partnership with Javara, announced today they have begun recruiting healthy adults for a Phase 3 clinical research study to evaluate the safety and effectiveness of mRNA-1273, a vaccine candidate against COVID-19. Sponsored by Moderna, the COVE Study is recruiting healthy volunteers ages 18 or older in high-risk populations, including the elderly, racial and ethnic minorities at higher risk for COVID-19, and essential workers in close contact with potentially infected persons.
The Phase 3 study will evaluate if mRNA-1273 boosts the immune system to produce enough antibodies against SARS-CoV-2, the virus that causes COVID-19, so it does not cause illness in case of infection.
“We are excited and hopeful as we begin participating in the COVE Study, understanding this is one of the most important and impactful clinical research studies in our lifetime,” said John Sanders, M.D., chief of infectious diseases and principal investigator, Wake Forest Baptist Health. “We encourage individuals across the Winston-Salem area to consider participating in this trial, which could bring the world one step closer to ending this global health crisis.”
To be eligible for the study, healthy volunteers must be 18 years of age and older with no known history of SARS-CoV-2 infection or previous participation in an investigational coronavirus vaccine. Within this population, Wake Forest Baptist Health and Javara are prioritizing candidates whose locations or circumstances put them at higher risk of exposure to the virus, including:
- Elderly, ages 65 and older
- Essential workers in close contact with potentially infected persons, including, but not limited to, healthcare and hospital workers, first responders, transit employees, institutional residents or workers, factory employees, and teachers and students
- Racial and ethnic minorities at high risk for COVID-19
If a person is eligible and decides to participate, the research staff at Wake Forest Baptist Health and in partnership with Javara will randomize patients to receive either the mRNA-1273 vaccine or a matching placebo. The total length of participation is 25 months and includes approximately seven visits to the clinic and 24 phone calls.
Wake Forest Baptist Health is one of 89 research sites across the country participating in the COVE Study.