Norton Healthcare part of Phase 3 vaccine trial with the University of Kentucky and Baptist Health Lexington
The long-anticipated interim results of a Phase 3 clinical trial on Johnson & Johnson’s COVID-19 vaccine candidate have been released. The University of Kentucky, in partnership with Baptist Health Lexington and Norton Healthcare in Louisville, are sites 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 interim results are positive, as they show that the vaccine is 85% effective in preventing people from getting a severe case of COVID-19,” said study sub investigator Paul S. Schulz, M.D., infectious diseases specialist and system epidemiologist at Norton Healthcare. “Twenty-eight days after receiving the vaccine, it showed complete protection in keeping people out of the hospital or preventing death from COVID-19.”
The vaccine is a single dose that does not require special refrigeration or freezing, making shipping and distribution less complicated than other products that require sub-zero temperatures. It is based on Janssen’s AdVac technology, which was used to develop Janssen’s European Commission-approved Ebola vaccine regimen and is the basis for its HIV, respiratory syncytial virus (RSV) and Zika vaccine candidates. To date, more than 140,000 individuals have been vaccinated with a Janssen AdVac-based vaccine or vaccine candidate.
Approximately 45,000 people participated in the Phase 3 clinical trial of this vaccine worldwide. The combined UK, Baptist Health Lexington and Norton Healthcare site was among the top enrolling sites in the world.
In addition to effectiveness, no significant safety concerns or anaphylaxis were reported.
This interim data also includes results from trials in Latin America and South Africa, where significant mutations have originated.
“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 Richard Greenberg, M.D., UK principal investigator with four decades of vaccine development experience.
“I am grateful to the hundreds of people who volunteered to be part of this trial locally, and the research team who worked countless hours in order to bring us one step closer to ending the pandemic,” Dr. Schulz said. “This was a huge undertaking, and it’s exciting to see some positive results.”