Study expects to enroll more than 12,000 students ages 18-26 years across the U.S.
SEATTLE, March 26, 2021 – The COVID-19 Prevention Network (CoVPN), headquartered at Fred Hutchinson Cancer Research Center, today 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 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," 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."
The Prevent COVID U study is a randomized, open-label, controlled study. Investigators will enroll approximately 12,000 college students aged 18-26 years at more than 20 universities across the U.S. and follow them over a five-month period. The study is funded by NIAID, part of the National Institutes of Health (NIH). Co-principal investigators leading the study are Audrey Pettifor, PhD, MPH, Professor of Epidemiology at the Gillings School of Global Public Health at University of North Carolina at Chapel Hill; Kathryn E. Stephenson, MD, MPH, Assistant Professor of Medicine, Harvard Medical School at the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center; and Jasmine R. Marcelin, MD, FACP, FIDSA, Assistant Professor of Infectious Diseases, University of Nebraska Medical Center.
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. Two separate studies in the CDC’s Morbidity and Mortality Weekly Report last October reported that SARS-CoV-2 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, 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," said Dr. Holly Janes, a professor at Fred Hutch and one of the leaders of the study.
Dr. Elizabeth Brown, a professor at Fred Hutch and a study leader who worked closely with Janes in designing the trial, agreed, noting that, "College campuses are model settings for studying transmission of infection, given that they are relatively closed populations."
Prevent COVID U opened initial study sites March 25. It is a 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 Dr. 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."
Students attending the following universities who are interested in participating in this important clinical trial may learn more or consider enrolling by going to PreventCovidU.
The COVID-19 Prevention Network (CoVPN) was formed by the National Institute of Allergy and Infectious Diseases (NIAID) at the U.S. 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.
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.
Content last reviewed on May 19, 2021