Here is the official news release:
Henry Ford Health System has been selected as a site for Janssen Pharmaceutical Companies of Johnson & Johnson’s Phase 3 clinical research study, ENSEMBLE trial, to evaluate the safety and efficacy of the Janssen’s investigational COVID-19 vaccine candidate, JNJ-78436735, also known as Ad26.COV2.S.
Recruiting of volunteers to participate in the vaccine trial will begin immediately. People interested in volunteering can find details about the trial on the Henry Ford website and sign up to volunteer here.
The Phase 3 randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the safety and efficacy of a single vaccine dose of the Janseen COVID-19 vaccine candidate versus placebo, in approximately 60,000 adults across the United States 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,” said Adnan Munkarah, M.D., Henry Ford Health System Executive Vice President and Chief Clinical Officer. “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 Health System will enroll adults from Southeast Michigan, aged 18 or older. Please visit the U.S. Clinical Trials website for more information about the inclusion and/or exclusion criteria of the Phase 3 ENSEMBLE clinical trial.
ENSEMBLE is being initiated in collaboration with the Assistant Secretary for Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
“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 developing severe symptoms,” says Dr. Munkarah. “I’d like to thank everyone who volunteers for contributing to the global effort to combat COVID-19.”
Henry Ford Health System is part of the NIAID-supported COVID-19 Prevention Network (CoVPN). The CoVPN is composed of existing NIAID-supported 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.