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]



Filters close

Showing results

110 of 6084
Newswise: Public
Released: 28-Jul-2021 2:45 PM EDT
Highly Potent, Stable Nanobodies Stop SARS-CoV-2
Max Planck Society (Max-Planck-Gesellschaft)

Göttingen researchers have developed mini-antibodies that efficiently block the coronavirus SARS-CoV-2 and its dangerous new variants.

Newswise: Public
Released: 28-Jul-2021 2:20 PM EDT
Psychological Consequences of COVID-19 in Health Care
University of Bonn

Physicians, nursing staff, medical technical assistants, and pastoral workers in hospitals: they have all been placed under severe strain by the Covid-19 pandemic.

Newswise: Public
Released: 28-Jul-2021 2:10 PM EDT
Why Lockdown in Africa Does Not Work as a First COVID-19 Pandemic Response
University of Johannesburg

In an African pandemic it is more productive to consider lockdowns, after using other non-medical measures first, Especially in countries with high levels of poverty and corruption, says Prof Nicholas Ngepah, a Professor of Economics at the University of Johannesburg in South Africa.

Newswise:Video Embedded how-to-talk-with-people-who-are-not-vaccinated-against-covid-19
VIDEO
Released: 28-Jul-2021 1:40 PM EDT
How to Talk With People Who Are Not Vaccinated Against COVID-19
Cedars-Sinai

Even though she has asthma, putting her at higher risk for severe complications from COVID-19, Angela Reeves-Flores, 33, waited until a week ago to get vaccinated.

Newswise: Indian Women’s Nutrition Suffered During COVID-19 Lockdown
Released: 28-Jul-2021 12:50 PM EDT
Indian Women’s Nutrition Suffered During COVID-19 Lockdown
Cornell University

A new study from Cornell University finds the nationwide lockdown India imposed last year in response to COVID-19 caused disruptions that negatively impacted women’s nutrition.

Released: 28-Jul-2021 12:00 PM EDT
MD Anderson Research Highlights for July 28, 2021
University of Texas M. D. Anderson Cancer Center

The University of Texas MD Anderson Cancer Center’s Research Highlights provides a glimpse into recently published studies in basic, translational and clinical cancer research from MD Anderson experts. Current advances include a newly discovered protein that controls B cell survival, understanding epigenetic changes in malignant peripheral nerve sheath tumors (MPNSTs) and melanoma, identifying a protein that protect genome stability, developing novel cell therapies for COVID-19, a new option for treating neuropathic pain, exosome delivery of CRISPR/Cas9 to pancreatic cancer, discovering how cancer cells tolerate aneuploidy and the role of health disparities in long-term survival of adolescent and young adult patients with Hodgkin lymphoma.

Released: 28-Jul-2021 11:30 AM EDT
Study Reveals Characteristics of SARS-CoV-2 Spike Protein
University of Kentucky

A new University of Kentucky College of Medicine study published in the Journal of Biological Chemistry provides foundational information about SARS-CoV-2’s spike protein.

access_time Embargo lifts in 2 days
Embargo will expire: 4-Aug-2021 9:00 AM EDT Released to reporters: 28-Jul-2021 11:15 AM EDT

A reporter's PressPass is required to access this story until the embargo expires on 4-Aug-2021 9:00 AM EDT The Newswise PressPass gives verified journalists access to embargoed stories. Please log in to complete a presspass application. If you have not yet registered, please Register. When you fill out the registration form, please identify yourself as a reporter in order to advance to the presspass application form.

Newswise: UIC Awarded $6 Million to Develop Potential COVID-19 Treatment
Released: 28-Jul-2021 10:15 AM EDT
UIC Awarded $6 Million to Develop Potential COVID-19 Treatment
University of Illinois Chicago

Researchers at the University of Illinois Chicago are developing a potential treatment for COVID-19, thanks to a $6 million technology and therapeutic development award from the U.S. Department of Defense supporting pre-clinical animal studies.

Newswise: Don’t Let the Raging Virus Put Life in Jeopardy. Chula Recommends How to Build an Immunity for Your Heart Against Stress and Depression
Released: 28-Jul-2021 8:55 AM EDT
Don’t Let the Raging Virus Put Life in Jeopardy. Chula Recommends How to Build an Immunity for Your Heart Against Stress and Depression
Chulalongkorn University

Cumulative stress, denial, and chronic depression are the byproducts of the COVID-19 pandemic. The Center for Psychological Wellness, Chulalongkorn University recommends ways to cope by harnessing positive energy from our heart.


Showing results

110 of 6084

close
1.22946