LEXINGTON, Ky. — The University of Kentucky, in partnership with Baptist Health Lexington and Norton Healthcare in Louisville, has been selected as a testing site for a COVID-19 vaccine candidate. 

The university will serve as a testing site for the Janssen Pharmaceutical Companies of Johnson & Johnson's Phase 3 clinical research study, called the ENSEMBLE trial, to evaluate Jansenn's investigational COVID-19 vaccine candidate, JNJ-78436735, also known as Ad26.COV2.S.

“Service to our Commonwealth is why UK was created," said UK President Eli Capilouto. "We are doing everything we can to respond and intervene against this pandemic, now including leading a vaccine clinical trial. We are proud of this opportunity to work with our communities—especially those most impacted—in efforts to contribute to the fight against COVID-19.”

The clinical trial, which is randomized, double-blind, and placebo-controlled, will examine the safety and efficacy of a single vaccine dose versus placebo in roughly 60,000 participants, including significant representation from those 60 and older.

Teams at UK, Baptist Health Lexington, and Norton Healthcare plan to enroll at least 2,000 local volunteers for the trial. Those 18 and over who meet inclusion criteria, including adults with and without health issues that put them at risk for severe COVID-19, can participate in the trial.

Those interested in participating in the trial can go online for more information, in addition to a pre-screening questionnaire. After filling it out, the research team may contact the applicant to determine eligibility. All information is confidential and completing the questionnaire doesn't obligate you to join the study. Qualified participants will be compensated.

This effort is being led by the university's Dr. Richard Greenberg, an infectious disease expert with four decades of experience in vaccine development.

Greenberg's previous work includes serving in Bihar, India for the effort by the World Health Organization to eradicate smallpox, leading a cooperative shingles prevention study with the VA in Lexington, and working with the military to develop vaccines for plague, botulism, and smallpox. Over his career, he had led over 28 vaccine trials and published more than 150 peer-reviewed papers.

“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,” Greenberg said. “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.”

At the university, the trial is organized and implemented through the UK Center for Clinical and Translational Science (CCTS), which also serves as the coordinating center for all three sites.

“The Center for Clinical and Translational Science is devoted to the stimulation of innovation, through the support of high-quality translational research, with an emphasis on team science, workforce development, and community engagement. COVID-19 is an urgent and critical public health crisis, and UK’s participation in this trial would not be possible without the CCTS infrastructure. We are proud and eager partners with Dr. Greenberg,” said CCTS Director Dr. Philip Kern.

Dr. David Dougherty, also an infectious disease specialist, is leading the Baptist Health Lexington branch of the study along with a clinical research team.

“We are proud to partner with other providers to bring the latest innovations in healthcare and wellness to our communities,” said William G. Sisson, president of Baptist Health Lexington.

The Norton Healthcare arm is led by infectious disease specialist and system epidemiologist Dr. Paul Schulz in Louisville.

“Norton Healthcare has one of the largest community healthcare system-based research portfolios in the country, and we know our employees and members of the community will step up to this opportunity to participate,” Schulz said.