Roughly 400 Stony Brook University students will participate in a nationwide, federally-funded clinical trial studying the infection and transmission rate of COVID-19 among college-aged students vaccinated with the Moderna vaccine, officials announced Tuesday.
The Prevent COVID U study, conducted by the Seattle-based COVID-19 Prevention Network will enroll more than 12,000 students ages 18 to 26 years at 22 colleges across the United States that perform routine testing for the virus among their student population.
"The new trial will tell us whether a person can become infected after they’ve been vaccinated and if the vaccine will stop the virus from spreading person-to-person," said Dr. Larry Corey, principal investigator of the Network's operations program, and one of the study leaders.
"The answers to these questions have implications for public health and will allow us to make more science-based decisions about mask use and social distancing post-vaccination — especially when new variants are emerging," Corey said.
Half of the study participants will be randomly selected to receive the vaccine immediately upon enrollment, while the other half will get the vaccine four months later. Throughout the study period, participants will complete a daily questionnaire, swab their nose daily for infection and provide periodic blood samples.
The first-of-its kind study, which is funded by the National Institute of Allergy and Infectious Diseases, is designed to determine, in a real-world setting, if the two-dose Moderna vaccine can prevent COVID-19 infection — including asymptomatic infection — and reduce transmission from vaccinated persons to their close contacts.
"By performing nose swabs daily for many weeks, we will be able to identify when people get infected, how high the viral titer is in their nose and for how long they are able to pass virus once infected," said Sharon Nachman, a Stony Brook professor of pediatrics and principal investigator for the university's arm of the trial.
Prevent COVID U opened initial study sites March 25. Stony Brook students will be selected in the coming weeks.
In addition, about 25,500 individuals identified by participants as "close contacts" will also take part in the trial to test the vaccine's effectiveness, answering weekly questionnaires, providing blood samples and taking daily swabs of their nose.
A high number of COVID-19 cases have been reported on college campuses.
A nationwide survey found that nearly 400,000 infections were counted at 1,800-plus universities after reopening in the fall of 2020. And from June to August of 2020, young people ages 20-29 accounted for more than 20% of all confirmed cases, data shows.
Kathryn Stephenson, one of the study chairs and an assistant professor of medicine at Harvard Medical School, said college campuses are a "perfect population" to determine if the vaccine is successful in preventing asymptomatic disease.
"That's what young people generally have most often," Stephenson said of asymptomatic transmission. "And these students are on university campuses in a situation where we know that transmission occurs."