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The University of Kentucky, in partnership with Baptist Health Lexington and Norton Healthcare in Louisville, participated as a site for the Janssen Pharmaceutical Companies of Johnson & Johnson’s Phase 3 clinical research study, called the ENSEMBLE trial, to evaluate Janssen’s investigational COVID-19 vaccine candidate, JNJ-78436735, also known as Ad26.COV2.S. The results of the trial were released today.

The Phase 3 randomized, double-blind, placebo-controlled clinical trial was designed to evaluate the safety and efficacy of a single vaccine dose of the Janssen investigational COVID-19 vaccine candidate versus placebo. Approximately 45,000 people participated worldwide. The combined UK, Baptist and Norton site was among the top enrolling sites in the world.

Johnson & Johnson’s press release about the study results is available here.

Janssen’s investigational COVID-19 vaccine leverages Janssen’s AdVac® technology. The same technology was used to develop Janssen’s European Commission-approved Ebola vaccine regimen and is the basis for its HIV, RSV and Zika vaccine candidates. To date, more than 140,000 individuals have been vaccinated with a Janssen AdVac®-based vaccine or vaccine candidate.

“The most important effort to end this pandemic requires the cooperation and participation of many scientists, doctors, public health leaders, politicians, and the people of the world,” said Dr. Richard Greenberg, UK principal investigator with four decades of vaccine development experience. “To have a chance to be a small part of the solution is not only an opportunity for the university but an honor for me. I thank the many people working so hard at all levels of this project—from those behind the scenes to all of our volunteers — because they know how important this to the world.”

 

Credits

Mallory Profeta (Center for Clinical and Translational Science)