Study Testing How Well COVID-19 Vaccine Prevents Spread of SARS-CoV-2 Among College Students Now Expands to Include Young Adults Beyond the University Setting

Expanded Study Also Includes Enrolling Young Adults Not Planning to be Vaccinated

SEATTLE, JUNE 30, 2021 – The Prevent COVID U study, which launched in late March to evaluate SARS-CoV-2 infection and transmission among college students vaccinated with the Moderna COVID-19 vaccine, has expanded to enroll young adults ages 18-29 beyond the university setting and will now include people in this age group who prefer not to receive a vaccine.

The expanded trial continues to test if, and to what degree, the Moderna COVID-19 mRNA-1273 vaccine can prevent infection with SARS-CoV-2, limit virus in the nose and reduce transmission of the virus from asymptomatic vaccinated persons to their close contacts. It is conducted through 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 (NIAID), part of the National Institutes of Health (NIH).

“Importantly, the initial study goals have not changed,” said Dr. Larry Corey, principal investigator of CoVPN’s operations program, professor at Fred Hutchinson Cancer Research Center and one of the study leaders. “But now with the widespread availability of COVID-19 vaccines and many colleges requiring vaccination among their students, we’re opening up the trial to enroll more people at more locations and now including those who don’t intend to get vaccinated in the near future.”

“This study modification to expand and include more young people, who are often asymptomatic, will help us more quickly and definitively determine if the vaccine works to prevent infection and spread of the virus,” added Dr. Jim Kublin, executive director of the CoVPN Operations Program at Fred Hutch. 

The Prevent COVID U study is a two-arm, randomized, open-label trial that will now enroll 18,000 individuals in the general population between ages 18-29. As in the initial trial, 6,000 individuals will be randomly selected to receive the vaccine right away at enrollment and another 6,000 will be randomized to follow local guidance and their preference for vaccination timing or be vaccinated through the study after four months. Additionally, the expanded study will enroll up to 6,000 young adults who prefer not to be vaccinated, which will help to ensure a large enough control group of non-vaccinated people to compare infection and transmission rates with those who have been vaccinated right away at enrollment. All participants who have not yet been vaccinated by the end of the four-month study will be offered the Moderna vaccine.

All participants in the study will complete questionnaires via an eDiary app twice weekly, swab their nose daily for SARS-CoV-2 infection and provide periodic blood samples. They will also be asked to identify their “close contacts,” such as family members, roommates or friends, who will then be invited to take part in the trial. If participants test positive for SARS-CoV-2, those contacts who agree to participate will be asked to answer weekly questionnaires via eDiary, provide two blood samples and take daily swabs of their nose for two weeks. 

To make it more convenient for people participating in the expanded trial, as many study procedures as possible will be conducted remotely and electronically, such as for initial screening and consent. Nasal swabs will be returned via the mail or dropped off at the study site. Study participants may be compensated approximately $900 for their time and inconvenience. 

"The expanded enrollment and inclusion of participants who prefer not to be vaccinated will ensure that the study successfully answers the critical questions as to vaccine effects on acquiring infection and transmitting infection to others," said Dr. Holly Janes, a professor at Fred Hutch and one of the leaders who designed the trial.

Dr. Elizabeth Brown, a professor at Fred Hutch who also helped design the trial agreed, adding that “main study participants receiving outside vaccinations will remain on the study and follow the same study procedures after vaccination.”

More than 40 sites across the U.S. will participate in the expanded study to include universities, health care centers and community organizations. Interested participants will be screened for eligibility through a phone app and if eligible, would schedule an appointment to enroll at the site nearest to them.

Co-principal investigators leading the expanded study are Audrey Pettifor, PhD, MPH, professor of Epidemiology at the Gillings School of Global Public Health at the University of North Carolina at Chapel Hill; Kathryn E. Stephenson, MD, MPH, assistant professor of Medicine, Harvard Medical School, and director of the Clinical Trials Unit 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.

“If our study demonstrates that a COVID-19 vaccine works to prevent infection and transmission of the virus, many more people may decide to get vaccinated, which has huge public health implications including guidance on what close interactions we can safely have with others,” said Corey.   

Sites Participating in Prevent COVID U Study

Individuals between the ages of 18-29 who are interested in participating in this important clinical trial may learn more or consider enrolling by visiting the PreventCovidU study website. 

State	City	Site Location
Alabama	Birmingham	University of Alabama
Arizona	Tempe	AMR Phoenix
Arizona	Tucson	University of Arizona
California	Los Angeles	Charles Drew University
California	Sacramento	Sacramento - Davis
California	San Diego	University of California, San Diego
Colorado	Boulder	University of Colorado, Boulder
Florida	Atlantis	JEM Headlands LLC
Florida	Gainesville	University of Florida
Florida	Jacksonville	UF Cares
Florida	Sarasota	Headlands Research Sarasota
Florida	Tampa	USF Genetics
Georgia	Atlanta	Morehouse School of Medicine
Georgia	Atlanta	Hope Clinic CRS
Illinois	Champaign	University of Illinois Urbana - Champaign
Illinois	Chicago	Northwestern University
Illinois	Rush	Chicago - Rush
Indiana	Bloomington	University of Indiana
Kansas	Wichita	University of Kansas
Kentucky	Lexington	University of Kentucky
Louisiana	Lake Charles	Centex Studies, Inc.
Maryland	College Park	University of Maryland - College Park
Massachusetts	Boston	Fenway Health CRS
Michigan	Detroit	Harper Hospital
Minnesota	Minneapolis	University of Minnesota
Missouri	Columbia	Columbia Missouri VTEU
Missouri	Kansas City	Children's Mercy
Missouri	St. Louis	Washington University Therapeutics
Nebraska	Omaha-McCulloh	University of Nebraska
Nevada	Las Vegas	AMR Las Vegas
New Mexico	Albuquerque	University of New Mexico
New York	Bellevue	NYU-VTEU, Bellevue
New York	Bronx	Columbia-Bronx Prevention CRS
New York	Harlem	Columbia-Harlem Prevention CRS
New York	New York	New York Blood Center CRS
New York	Mineola	NYU-VTEU, Mineola
New York	Stony Brook	Stony Brook University
North Carolina	Chapel Hill	University of North Carolina
North Carolina	Winston-Salem	Wake Forest University
Rhode Island	Providence	The Miriam Hospital
South Carolina	Clemson	Clemson University
Tennessee	Nashville	Vanderbilt University
Texas	Amarillo	Texas Tech
Texas	Brownsville	Centex Studies, Inc.
Texas	College Station	Texas A&M Health Science Center
Texas	Houston-Pouzar	Centex Studies, Inc.
Texas	Houston-Westfield	Centex Studies, Inc.
Texas	Kingsville	Texas A&M Health Science Center
Texas	McAllen	Centex Studies, Inc.
Virginia	Charlottesville	University of Virginia
Washington	Seattle	University of Washington

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 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.

About Fred Hutch 

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 and COVID-19 Prevention Network.

Media Contacts

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