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

Expanded study also includes enrolling young adults not planning to be vaccinated

Newswise — SEATTLE (JUNE 22, 2021) – The Prevent COVID U study, which launched in late March 2021 to evaluate SARS-CoV-2 infection and transmission among university students vaccinated with the Moderna COVID-19 Vaccine, has expanded beyond the university setting to enroll young adults ages 18 through 29 years and will now also include people in this age group who choose not to receive a vaccine.

The expanded trial continues to test if, and to what degree, the Moderna COVID-19 Vaccine can prevent infection with SARS-CoV-2, limit the amount of virus in the nose, and reduce transmission of the virus from vaccinated persons to their close contacts. It is being conducted through the COVID-19 Prevention Network (CoVPN), operationally 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 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 choose 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 COVID-19 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 including universities, health care centers, and community organizations across the U.S. will participate in the expanded study. 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

Anna Altavas
425-275-7408
[email protected]

Claire Hudson
206-919-8300
[email protected]



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