The Phase 3 randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the safety and efficacy of a single vaccine dose of the Janssen investigational COVID-19 vaccine candidate.
The University of Kentucky, in partnership with Baptist Health Lexington and Norton Healthcare in Louisville, has been selected as a testing 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 Phase 3 randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the safety and efficacy of a single vaccine dose of the Janssen investigational COVID-19 vaccine candidate versus placebo, in approximately 60,000, including significant representation from those that are over 60.
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 100,000 individuals have been vaccinated with a Janssen AdVac®-based vaccine.
The UK, Baptist Health Lexington and Norton Healthcare research teams plan to enroll at least 2,000 local volunteers for the trial, which is open to people over 18 who meet inclusion criteria, including adults with and without other health issues associated with an increased risk for progression to severe COVID-19. UK’s Dr. Richard Greenberg, an infectious disease expert with four decades of experience in vaccine development, leads this local effort.
“Service to our Commonwealth is why UK was created. 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,” said UK President Eli Capilouto.
Janssen has also joined other pharmaceutical companies in making a pledge to the world that it will continue to adhere to its high scientific, ethical and regulatory standards and will rely on robust clinical evidence to guide the development of its investigational COVID-19 vaccine candidate. Janssen is committed to transparency and sharing information related to the Phase 3 ENSEMBLE study – including the study protocol.
Greenberg, the principal investigator for the study, brings extensive expertise to the trial. His history in vaccine development includes serving in Bihar, India for the successful effort by the World Health Organization to eradicate smallpox, leading a cooperative shingles prevention study with the VA here in Lexington, and working in a partnership with the military to develop vaccines for plague, botulism, and smallpox. He has led more than 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. And 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 is to the world.”
Individuals interested in learning more about participating in the trial in the Louisville area can visit NortonHealthcare.com/COVIDstudy to find more information and answer a pre-screening questionnaire, after which the research team might contact them to determine if they are eligible.
Qualified participants will be compensated. All information is confidential, and answering the questionnaire does not obligate you to join the study.
Additional information is available at Janssen’s ENSEMBLE website.
At UK, the trial is organized and implemented through the infrastructure of the Center for Clinical and Translational Science (CCTS), whose mission is to accelerate discoveries that improve health.
The CCTS 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 Dr. Philip Kern, CCTS director.
The Baptist Health Lexington arm of the study is led by Dr. David Dougherty, infectious disease specialist and principal investigator, 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.
In Louisville, the Norton Healthcare arm of the study is led by infectious disease specialist and system epidemiologist Dr. Paul Schulz.
“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,” Dr. Schulz said.
ENSEMBLE is being initiated in collaboration with the Assistant Secretary for Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Other Transaction Agreement HHSO100201700018C.