LEXINGTON, Ky. —  A clinical trial at the University of Kentucky (UK) will examine if Moderna's COVID-19 vaccine prevents transmission and infection among post-secondary students after the university was selected as a site for PreventCovidU. Students aged 18-26 who are enrolled in any post-secondary education — including colleges, trade schools, technical schools, and online education — may be eligible to participate.

"This study will help definitively answer whether the FDA-authorized Moderna COVID-19 vaccine prevents the spread of the virus, not just illness in the person who’s vaccinated," said a release from UK. "This is an urgent question for the entire world, as we still don’t know if vaccinated people can develop asymptomatic infections that allow them to transmit the virus to others."

PreventCovidU will use daily nose swabs to measure virus loads in the noses of vaccinated people and will invite "close contacts" of those who are tested as well.

"Researchers hope the study results will allow us to make more science-based decisions about mask use and social distancing after vaccination, especially as new variants emerge," the release said.

If you're a post-secondary student interested in participating, visit StopCOVIDKy.com and complete a pre-screening survey to help determine eligibility. Participants will be compensated. About 150 local students, and about 12,000 nationally, will be enrolled in the trial. Participants from 20 universities will be followed over five months.

According to Dr. Holly Janes, a professor at Fred Hutchinson Cancer Research Center and one of the leaders of the study, high-density housing, the impulse to socialize and less fear of severe disease in young people are all factors that contribute to the high burden of COVID-19 infection on college campuses.

Dr. Richard Greenberg, Dr. Christopher Simmons, Dr. Philip Kern, Dr. T. Shawn Caudill and George Hoover are leading the PreventCovidU study at UK. Greenberg brings four decades of vaccine development experience and is also leading trials of the Johnson & Johnson COVID-19 vaccine at UK, which was the world’s top-enrolling site for the company’s single-dose trial, according to the university.

“We’re proud to be part of this important study that will help resolve a critical question in ending the pandemic — whether the mRNA vaccines prevent someone from spreading the COVID-19 virus even if they’ve been vaccinated and don’t have symptoms,” Simmons said. “We’re deeply grateful to the UK students who will choose to participate in PreventCovidU — they are offering a great service by joining this historic effort.” 

Led by Kern, the UK Center for Clinical & Translational Science (CCTS) is implementing the Johnson & Johnson and PreventCovidU trials at UK. 

“Our mission at the CCTS is to accelerate discoveries that improve health in the Commonwealth and beyond. Providing the infrastructure for COVID-19 vaccine trials at UK embodies the reason we’re here,” said Kern. 

PreventCovidU is a randomized, open-label, controlled study with two arms: Half of the students will be randomly selected to receive the vaccine right at enrollment, while the other half will get the vaccine up to four months later. All participants will know which arm of the trial they’re in at enrollment and all will ultimately receive the vaccine. Participants are not prevented from receiving another vaccine in their community if they are offered but will be asked to remain in the study for the five-month observation. During that time, participants will complete questionnaires via an eDiary app, swab their nose daily for COVID-19 infection and provide periodic blood samples. 

Because testing the vaccine’s effectiveness to reduce and/or prevent transmission requires measuring the spread of the virus to others, about 25,500 individuals identified by participants in the main study as “close contacts” also will be invited to take part in the trial. Close contacts who participate in the study will be asked to answer weekly questionnaires via eDiary, provide two blood samples and take daily swabs of their nose for two weeks. 

“With this trial, the University of Kentucky adds to its already extensive clinical research effort to end this pandemic. It shows the nation, not only by the efforts of its academic leaders but also by the resolve of its students, that UK cares,” Greenberg said. 

PreventCovidU is designed and managed by the COVID-19 Prevention Network (CoVPN), headquartered at Fred Hutchinson Cancer Research Center, and funded by the Federal COVID-19 Response Program and the National Institute of Allergy and Infectious Diseases, led by Dr. Anthony Fauci.