DETROIT – 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 the company 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.
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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.
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“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.
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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.