LEXINGTON, Ky. – University of Kentucky has been selected as a site for a PreventCovidU study evaluating COVID-19 infection and transmission among post-secondary students vaccinated with the Moderna COVID-19 vaccine.
This study will help answer whether the FDA-authorized Moderna COVID-19 vaccine prevents spread of the virus in addition to preventing the person who’s vaccinated from becoming ill. This remains an urgent question for the entire world, as it remains unknown if vaccinated people can develop asymptomatic infections that allow them to transmit virus to others.
Students aged 18 to 26 enrolled in any post-secondary education — including colleges, trade schools, technical schools and online education — may be eligible to participate. Interested post-secondary students can visit StopCOVIDKy.com to learn more and complete a pre-screening survey. Participants will be compensated. Around 150 local students, and about 12,000 nationally, will be enrolled in the trial. Participants from 20 universities will be followed over a five-month period.
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 (which Dr. AnthonyFauci leads).
Uniquely, PreventCovidU will utilize daily nose swabs to measure virus load in the noses of vaccinated people and will also invite “close contacts” of those people to be tested as well. Daily testing is key to understanding the stealthy nature of COVID-19, also known as SARS-CoV-2.
Studies suggest a person is most infectious for only a few days, often before the onset, if ever, of any COVID-19 symptoms. Roughly half of infections remain asymptomatic.
Researchers believe study results will allow more science-based decisions about mask use and social distancing after vaccination, especially as new variants emerge.
Large numbers of COVID-19 infections have been reported on campuses throughout the country. A nationwide survey found more than 397,000 infections were counted at 1,800-plus universities after reopening in the fall of 2020. Two separate studies in the CDC’s Morbidity and Mortality Weekly Report last October reported that infections among young people aged 18-22 increased 55% nationally between August and September 2020. Between June and August 2020, young people aged 20-29 had the highest incidence of SARS-CoV-2 infection in the U.S., accounting for more than 20% of all confirmed cases.
High-density housing, 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, according to Dr. Holly Janes, a professor at Fred Hutchinson Cancer Research Center and one of the leaders of the study.
At UK, the PreventCovidU study is led by Dr. Richard Greenberg, Dr. Christopher Simmons, Dr. Philip Kern, Dr. T. Shawn Caudill and George Hoover. 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.
“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,” Simmons said.
The UK Center for Clinical & Translational Science (CCTS), led by Kern, 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.
Because testing the vaccine’s effectiveness to reduce and/or prevent transmission requires measuring 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 have agreed to 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.