The COVID-19 Prevention Network (CoVPN), headquartered at Fred Hutchinson Cancer Research Center, has announced the launch of Prevent COVID U, a new study evaluating SARS-CoV-2 infection and transmission among college students vaccinated with the Moderna COVID-19 vaccine, mRNA-1273.
The trial is funded by the Federal COVID-19 Response Program and the National Institute of Allergy and Infectious Diseases (NIAID). It is designed to determine if the mRNA-1273 vaccine, currently authorized for emergency use by the U.S. Food and Drug Administration, can prevent infection with SARS-CoV-2 (including asymptomatic infection), limit virus in the nose, and reduce transmission of the virus from vaccinated persons to their close contacts.
“This study builds on the Phase III 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,” said 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.”
Large numbers of SARS-CoV-2 infections have been reported on campuses throughout the U.S. A nationwide survey found that more than 397,000 infections were counted at 1,800-plus universities after reopening in the fall of 2020.
The Prevent COVID U study is a randomized, open-label, controlled study. Investigators will enroll approximately 12,000 college students aged 18 to 26 years at more than 20 universities across the U.S. and follow them over a five-month period. In the two-arm trial, 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 arm of the trial they are in at enrollment and all will ultimately receive the vaccine. Throughout the study period, 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.
“Our hope is that we demonstrate that COVID-19 vaccines prevent people from getting infected with coronavirus in the first place and that it stops transmission to others,” said Corey. “The emphasis on following close contacts among those students who acquire COVID-19 in the trial is one of the unique aspects of the trial.”
Universities participating in the study include Charles Drew University, Clemson University, Indiana University at Bloomington, Morehouse School of Medicine, Northwestern University, Stony Brook University, Texas A&M College Station, Texas A&M Kingsville, University of Arizona, University of California San Diego, University of Colorado Boulder, University of Florida at Gainesville, University of Illinois at Urbana-Champaign, University of Kentucky, University of Maryland at College Park, University of Nebraska, University of North Carolina, University of Virginia, University of Washington, Wake Forest, West Virginia University, and Winston-Salem State University.
Edited by Gary Cramer