U-M to begin recruitment for Janssen COVID-19 vaccine phase 3 clinical trial
Michigan Medicine is partnering with Janssen, a division of Johnson & Johnson, for a double-blind phase III clinical trial to test a vaccine against COVID-19.
The trial, known as the ENSEMBLE study, will evaluate an investigational vaccine for the prevention of COVID-19, the disease caused by the new coronavirus (SARS-CoV-2).
Recruitment for the Janssen trial will begin immediately.
U-M is one of several U.S. and international sites supporting the trial, which seeks to enroll a diverse group of up to 60,000 volunteers worldwide. It is the latest trial to launch as part of Operation Warp Speed, a public/private partnership under the U.S. Department of Health and Human Services.
“Michigan Medicine is committed to supporting the continued study of the investigational Janssen vaccine and other vaccine candidates. These trials are crucial to moving us toward an effective vaccine,” said Marschall Runge, M.D., Ph.D., dean of the U-M Medical School, executive vice president for medical affairs and CEO of Michigan Medicine.
The Janssen study joins the AstraZeneca trial as the second COVID-19 vaccine trial recruiting at U-M. Interested participants meeting eligibility criteria can be considered for either trial when enrollment is open.