Henry Ford Health System Begins Enrollment for 2-Dose Trial of J & J’s COVID-19 Vaccine

February 15, 2021
J&J Ensemble 2 vaccine trial

DETROIT (February 15, 2021) – Henry Ford Health System is enrolling volunteers ages 60 and older for Johnson & Johnson’s Phase 3 ENSEMBLE 2 clinical trial to evaluate the safety and efficacy of a two-dose regimen of the COVID-19 vaccine recently submitted by J & J to the FDA for Emergency Use Authorization.

Late last year, Henry Ford was a leading site for enrolling minority participants as a Phase 3 trial site for Johnson & Johnson’s ENSEMBLE 1, the study to determine the safety and efficacy of the one-dose regimen of the vaccine. That trial showed that the single-shot version of the vaccine was 85% effective overall in preventing severe disease and complete protection against COVID-19 related hospitalization and death. It was 65% effective overall in preventing moderate to severe COVID-19.

Henry Ford was also a Phase 3 trial site for the Moderna two-shot mRNA vaccine, which, along with an mRNA vaccine from Pfizer, was given Emergency Use Authorization by the FDA late last year.

“We are grateful to have been chosen once again as a study site for a late-stage COVID-19 vaccine trial and to play a pivotal role in the collective effort to stop this pandemic,” said Adnan Munkarah, M.D., Executive Vice President and Chief Clinical Officer at Henry Ford. “It is imperative that we have as many effective vaccine candidates as possible, especially as we begin to see different variants of the disease, and so we encourage anyone who may qualify for this vaccine trial to consider participating.”

ENSEMBLE 2 is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of the Janssen vaccine candidate versus placebo. In a randomized, double-blind study neither the participants or the research staff know whether the participants receive the investigational vaccine or a placebo.

Trial participants must be between the ages of 60 and older. Anyone interested in volunteering may sign up at this link on the Henry Ford website. Eligible participants will receive two doses of either the investigational vaccine or a placebo, with the doses given 57 days apart. For more information about trial, click here.

For the duration of the trial, which will last for two years and two months, participants will be asked to monitor for symptoms that could be related to COVID-19 and report their symptoms using an assessment tool provided by Henry Ford’s research staff. In addition, participants will provide blood, saliva and nasal swab at the initial visit. The participants will be asked to complete four in-person study visits in addition to phone interviews with the research study team.

ENSEMBLE 2 is being conducted 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.

Henry Ford 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.

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 includes Henry Ford Medical Group, with more than 1,900 physicians and researchers practicing in more than 50 specialties at locations throughout Southeast and Central Michigan. Acute care hospitals include Henry Ford Hospital in Detroit, MI and Henry Ford Allegiance Health in Jackson, MI – both Magnet® hospitals; Henry Ford Macomb Hospital; Henry Ford West Bloomfield Hospital; and Henry Ford Wyandotte Hospital.

The largest of these is Henry Ford Hospital in Detroit, a quaternary care research and teaching hospital and Level 1 Trauma Center recognized for clinical excellence in cardiology, cardiovascular surgery, neurology, neurosurgery, and multi-organ transplants. The health system also provides comprehensive, best-in-class care for cancer at the Brigitte Harris Cancer Pavilion, and orthopedics and sports medicine at the William Clay Ford Center for Athletic Medicine – both in Detroit.

As one of the nation’s leading academic medical centers, Henry Ford Health System annually trains more than 3,000 medical students, residents, and fellows 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.

Our not-for-profit health plan, Health Alliance Plan (HAP) provides health coverage for more than 540,000 people.

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.

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