University of Kentucky, Baptist get COVID-19 vaccine trial; 2,000 volunteers wanted

The University of Kentucky and partner Baptist Health Lexington will conduct a COVID-19 vaccine trial, the school announced Thursday.

Norton Healthcare in Louisville is also a partner in the study, which plans to enroll 2,000 volunteers to receive a single dose. Participants will be monitored by researchers at one of the three locations through March of 2023.

The drug study is part of the larger “ENSEMBLE study,” which is being conducted by Janssen Pharmaceutica, a subsidiary of Johnson & Johnson. Close to 60,000 people worldwide are expected to take part in the trial, according to the study’s website.

Kentucky’s arm of the vaccine trial has entered phase 3, which means there’s reliable evidence to suggest the drug is safe to test in a larger group of people, Dr. Paul Schulz, infectious disease specialist and epidemiologist with Norton Healthcare, said in a virtual press conference Thursday morning.

This two-year phase of the study will help determine how safe and effective the vaccine is for wide-scale distribution, said UK’s Dr. Richard Greenberg, investigative disease specialist and principal investigator of the study. It’s a randomized double-blind placebo study, meaning roughly half of the volunteers will receive the trial vaccine and the other half will get a placebo.

Volunteers, once they receive their injection, will be monitored remotely for two years: twice weekly during the first year, and twice a month during the second, Greenberg said. Close to 70 people are already enrolled.

The ideal population of trial volunteers are those most at risk of catching and suffering from the virus, including people who work public-facing jobs, including health care workers, nursing home staff, teachers, and grocery store and restaurant workers, Greenberg said. Kentuckians over age 60 are also a target demographic, as are Black and Latinx residents, who’ve been disproportionately impacted by the virus.

The experimental vaccine does not include the live virus, UK said. Volunteers will be paid, though members of the research team declined to say how much. Side effects of the trial vaccine are expected to be mild — a sore arm, headache, general malaise, Greenberg said.

So far, “we’ve not seen any clear-cut evidence of any severe significant illness,” he added.

Volunteers must be 18 or older, be in “good or stable health” and can’t have received a previous COVID-19 vaccine, according to the study’s website. People who’ve already had COVID-19 can participate, but they can’t be actively infected with the live virus. The study team will contact participants it selects over the next eight to 10 weeks.

Those interested in being a volunteer can find more information at stopcovidky.com.

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