SEATTLE, WA. — Students attending more than 20 universities are participating in a new COVID-19 Prevention Network (CoVPN) study that evaluates SARS-CoV-2 infection and transmission among college students vaccinated with the Moderna COVID-19 vaccine.
Headquartered at the Fred Hutchinson Cancer Research Center in Seattle, Washington, the "Prevent COVID U" trial expects to enroll more than 12,000 students ages 18-26 across the country. Among the colleges participating is Indiana University's Bloomington campus.
The trial will work to determine if the Moderna vaccine can prevent infection with SARS-CoV-2 — which is "severe acute respiratory syndrome coronavirus 2.” This virus is genetically related to the coronavirus responsible for the SARS outbreak of 2003. While related, the two viruses are different, according to the World Health Organization. It will also determine if the vaccine can limit the virus in the nose, and reduce transmission of the virus from vaccinated persons to their close contacts.
A nationwide survey found that almost 400,000 SARS-CoV-2 infections were counted at more than 1,800 universities after reopening in fall 2020. Last October, a study by the Centers for Disease Control and Prevention found that young people aged 18-22 infected with SARS-CoV-2 increased by 55% nationally between August and September in 2020. And between June and August 2020, people ages 20-29 accounted for more than 20% of all confirmed cases in the country.
“This study builds on the Phase 3 COVID-19 clinical trials that tested the ability of vaccines to prevent symptomatic and severe COVID-19 disease in adults. 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,” stated Dr. Larry Corey, Principal Investigator of CoVPN’s operations program, Professor at Fred Hutchinson Cancer Research Center, 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.”
The Prevent COVID U trial is funded by the Federal COVID-19 Response Program and the National Institute of Allergy and Infectious Diseases (NIAID). It is a randomized, open-label, and controlled study, that plans to follow participating students over a five-month period.
“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 SARS-CoV-2 infection on college campuses,” Dr. Holly Janes, a professor at Fred Hutch and one of the leaders of the study, stated in a release to WRTV.
The Prevent COVID U opened initial study sites on March 25. According to CoVPN, it is a "two-arm trial," in which half of the students will be randomly selected to receive the vaccine right away at enrollment, while the other half will get the vaccine four months later. All participants will know which part of the trial they are in and will complete questionnaires through an eDiary app, swab their nose daily for COVID-19 infection and provide periodic blood samples.
Close contacts of those who choose to be a part of the trial may also be asked to answer weekly questionnaires, provide two blood samples and take daily swabs of their nose for two weeks.