Physician-researchers with the University of Miami Miller School of Medicine have begun a new Phase 3 clinical trial to test another investigational vaccine for COVID-19.
Part of a large-scale international trial in partnership with Janssen Pharmaceuticals, the clinical trial to test the Janssen vaccine is the Miller School’s second in human study of its kind.
“With the availability of test vaccines, I feel very encouraged, enthusiastic and optimistic that we will overcome this pandemic soon,” said Dushyantha Jayaweera, M.D., professor of medicine and principal investigator for Janssen’s UM site. Dr. Jayaweera leads the study along with co-principal investigator Olveen Carrasquillo, M.D., M.P.H., professor of medicine and public health sciences and chief of the Division of General Internal Medicine.
“It is critically important that we enroll a very diverse population for the study,” said Dr. Carrasquillo, a national authority on population health. “That way we can ensure that the vaccine will be equally effective for all groups.”
The study, titled ENSEMBLE, plans to enroll up to 60,000 volunteers across three continents. At the Miller School site for the Janssen vaccine, researchers plan to enroll up to 1,500 volunteers in South Florida. Diverse recruitment, especially of Blacks and Latinos, is a major goal.
The trial is randomized and double-blind to assess the efficacy and safety of the Janssen vaccine for the prevention of SARS-CoV-2.
The trial is designed to evaluate if the investigational Janssen vaccine can prevent symptomatic COVID-19 after a single-dose regimen.
Prospective study volunteers will need to be 18 or older. Miller School clinical researchers plan to recruit young and older adults, including some older volunteers with existing co-morbidities. Eligible study participants, who have not previously had COVID-19, will receive one injection of either the vaccine or the placebo and will be followed over two years.
The Miller School of Medicine is a major research center for infectious diseases, particularly HIV and AIDS. UM initiated vaccine trials for COVID-19 in July as a partner site with the National Institutes of Health COVID-19 Prevention Trials Network. The Moderna vaccine was the first to be tested through the network.
“Conducting a vaccine clinical trial needs a team of teams approach from the research community and willing volunteers,” said Dr. Jayaweera. “This is a historic moment and these vaccine trials give us hope.”
More information on the Janssen vaccine trial is available here.