DETROIT – 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.
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 Janssen 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.
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About Henry Ford Health System
Founded in 1915 by Henry Ford himself, Henry Ford Health System is a non-profit, integrated health system committed to improving people’s lives through excellence in the science and art of healthcare and healing. Henry Ford Health System consists of six hospitals including Henry Ford Hospital in Detroit; Henry Ford Macomb Hospitals; Henry Ford Wyandotte Hospital; Henry Ford West Bloomfield Hospital; Henry Ford Allegiance in Jackson, MI; and Henry Ford Kingswood Hospital – an inpatient psychiatric hospital.
Henry Ford Health System also includes Henry Ford Medical Group; Henry Ford Physician Network; more than 250 outpatient facilities; Henry Ford Pharmacy; Henry Ford OptimEyes; and other healthcare services. Our not-for-profit health plan, Health Alliance Plan (HAP) provides health coverage for more than 540,000 people.
As one of the nation’s leading academic medical centers, Henry Ford Health System trains more than 3,000 medical students, residents, and fellows annually in more than 50 accredited programs, and has trained nearly 40% of the state’s physicians. Our dedication to education and research is supported by nearly $100 million in annual grants from the National Institutes of Health and other public and private foundations.
Henry Ford Health System employs more than 33,000 people, including more than 1,600 physicians, more than 6,600 nurses and 5,000 allied health professionals. For more information, visit HenryFord.com.