Clinical Trial at UK Will Test If COVID-19 Vaccine Prevents Transmission and Infection Among Post-Secondary Students

The University of Kentucky has been selected as a site for PreventCovidU, a new study evaluating COVID-19 infection and transmission among post-secondary students vaccinated with the Moderna COVID-19 vaccine. Students aged 18 to 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. 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. 

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 iskey to understanding the stealthy nature of COVID-19,alsoknown 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 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.

Post-secondary students interested in participating can visit StopCOVIDKy.com to learn more and complete a pre-screening survey that will help determine if they’re eligible. Participants will be compensated. Around150 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.

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 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.”

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. 

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 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.

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). 

More information is available at StopCOVIDKy.com and on the PreventCovidU website. This article includes reporting from the CoVPN and the Fred Hutch News Service.

About The COVID-19 Prevention Network (CoVPN)  The COVID-19 Prevention Network (CoVPN) was formed by the National Institute of Allergy and Infectious Diseases (NIAID) at the US National Institutes of Health to respond to the global pandemic. Through the CoVPN, NIAID is leveraging the infectious disease expertise of its existing research networks and global partners to address the pressing need for vaccines and antibodies against SARS-CoV-2. CoVPN will work to develop and conduct studies to ensure rapid and thorough evaluation of vaccines and antibodies for the prevention of COVID-19. The CoVPN is headquartered at the Fred Hutchinson Cancer Research Center.  About Fred Hutchison Cancer Research Center  At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer.An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network.