Nationwide Phase 3 trial testing for safety, effectiveness of investigational vaccine
Researchers at Beaumont Hospital in Royal Oak are enrolling patients in a national study to test the safety and effectiveness of an investigational COVID-19 vaccine known as AZD1222.
“Because there is currently no FDA-approved vaccine to prevent COVID-19, we’re eager to have Beaumont participate as one of the trial sites,” said Dr. Christopher Carpenter principal investigator for the study site and chair of the Department of Medicine, Beaumont, Royal Oak. “Beaumont Health cared for the most COVID-19 patients in Michigan during the surge in March and April. We’re hopeful the study will attract a diverse group of participants.”
The Phase 3 research, known as the AZD1222 COVID-19 Vaccine Study, is seeking about 40,000 participants nationwide. Those who meet the study criteria will receive two injections four weeks apart. Participants will not be told if they are receiving the vaccine or a placebo. Two-thirds of the study volunteers will receive the investigational vaccine, and the other one-third will receive a placebo. A placebo looks like the investigational vaccine, but contains no active vaccine. Participants will be followed for approximately two years.
The National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority, part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, are providing funding for the research study. The Phase 3 trial is part of Operation Warp Speed, a collaboration led by the HHS.
“This large-scale study definitely has the potential to save lives across our state, the nation and across the globe,” said Dr. Matthew Sims, director of Infectious Diseases Research, Beaumont Health.
Researchers are seeking:
• People 18 years of age or older, in good or stable health. They may have an underlying medical condition and still take part, if their disease is stable.
• Individuals with an increased risk of getting COVID-19 or those at greater risk of developing complications from COVID-19.
• Those who do not have a previously confirmed diagnosis of COVID-19.
All clinic visits will take place at Beaumont Hospital, Royal Oak. Tests will be provided at no cost. Participants will be reimbursed for their time and travel.
To learn more about the study, click here.