Detroit-based Henry Ford Health System has been selected as a site for a Phase 3 clinical research study to evaluate the safety and efficacy of an investigational COVID-19 vaccine candidate.
Janssen Pharmaceutical Cos. of Johnson and Johnson have created the ENSEMBLE trial to test the candidate, which is called JNJ-78436735 or Ad26.COV2.S.
Volunteer recruiting will begin immediately. More information on participation is available here.
The Phase 3 randomized, double-blind, placebo-controlled clinical trial is designed to evaluate a single dose of the vaccine candidate versus the placebo in about 60,000 adults across the U.S. and internationally, including significant representation among study participants of people over 60 years of age.
“We are honored to be one of only three sites in Michigan to participate in Phase 3 trials for Janssen’s COVID-19 vaccine candidate,” says Dr. Adnan Munkarah, executive vice president and chief clinical officer of Henry Ford Health System. “Henry Ford Health System has become a leader in treating COVID- 19, as well as the study and development of potential vaccines and innovative therapeutics. We believe participating in this latest trial is an important part of our effort to stop this global pandemic.”
The trial will include people with and without comorbidities associated with an increased risk for progression to severe COVID-19. Researchers at Henry Ford will enroll adults from southeast Michigan ages 18 and older. More information on inclusion and exclusion from the trial is available here.
ENSEMBLE is being initiated in collaboration with the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, and the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
“We hope southeast Michigan residents will consider taking part in the vaccine trial, particularly people who are at a higher risk of coming in contact with the virus, and people who have a higher likelihood of developing severe symptoms,” says Munkarah. “I’d like to thank everyone who volunteers for contributing to the global effort to combat COVID-19.”
The health system is part of the National Institute of Allergy and Infectious Diseases-supported COVID-19 Prevention Network. The network is composed of existing clinical research networks with infectious disease expertise and is designed for rapid and thorough evaluation of vaccine candidates and monoclonal antibodies for the prevention of COVID-19.