Expanded COVID U Prevention Study Also Includes Adults Ages 18-29 Who Are Not Affiliated With A University

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

Expanded trial continues to test whether, and to what extent, the Moderna COVID-19 vaccine can prevent SARS-CoV-2 infection, limit the amount of virus in the nose, and reduce transmission of the virus from those vaccinated to their loved ones. Contacts. It is conducted through the COVID-19 Prevention Network (CoVPN), whose operational headquarters are at the Fred Hutchinson Cancer Research Center, and funded by the Federal COVID-19 Response Program and the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health (NIH).

“It is important to note that the original objectives of the study have not changed,” said Dr Larry Corey, principal investigator of the CoVPN operational program, professor at the Fred Hutchinson Cancer Research Center and one of the heads of file of the study. “But now, with the widespread availability of COVID-19 vaccines and many colleges requiring vaccination among their students, we are opening the trial to enroll more people in more places and now include those who do not have it. intend to be vaccinated in the near future. ”

“Changing the study to expand and include more young people, who are often asymptomatic, will help us determine more quickly and definitively whether the vaccine is working to prevent infection and the spread of the virus,” added Dr. Jim Kublin. , Executive Director of CoVPN. Program of operations at Fred Hutch.

The Prevent COVID U study is an open-label randomized trial that will now enroll 18,000 people in the general population aged 18 to 29. As in the initial trial, 6,000 people will be randomly selected to receive the vaccine immediately upon enrollment and another 6,000 will be randomized to follow local guidelines and their preference for the immunization schedule or be vaccinated as part of the trial. of the study after four months. Additionally, the expanded study will recruit up to 6,000 young adults who choose not to be vaccinated, which will help ensure a large enough control group of unvaccinated people to compare infection and transmission rates with those who do. were vaccinated immediately upon registration. . 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 study participants will complete questionnaires through an eDiary app twice a week, swab their noses 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 participate in the trial. If participants test positive for SARS-CoV-2, contacts who agree to participate will be asked to complete weekly questionnaires via eDiary, provide two blood samples, and take daily nose swabs 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 by mail or dropped off at the study site. Study participants can be compensated around $ 900 for their time and inconvenience.

“The expanded recruitment and inclusion of participants who prefer not to be vaccinated will ensure that the study will successfully answer critical questions about the effects of the vaccine on the acquisition of infection and the transmission of infection to d. ‘others,’ said Dr Holly Janes, professor at Fred Hutch and one of the executives who designed the trial.

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

More than 40 sites, including universities, health care centers and community organizations across the United States, will participate in the expanded study. Interested participants will be selected for their eligibility via a phone application and, if eligible, will make an appointment to register at the site closest 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 shows that a COVID-19 vaccine works to prevent infection and transmission of the virus, many more people could decide to get vaccinated, which has huge public health implications, including advice on the close interactions we can have safely with others. Corey said.

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SITES PARTICIPATING IN THE STUDY PREVENT COVID U

Those aged 18 to 29 who are interested in participating in this important clinical trial can 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 – YWAM 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 – Indiana University

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 – Colombia – Colombia 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 CRS Prevention

New York – Harlem – Columbia-Harlem CRS Prevention

New York – New York – New York Blood Center CRS

New York – Mineola – NYU-VTEU, Mineola

New York – Stony Brook – Tony Brook University

North Carolina – Chapel Hill – University of North Carolina

North Carolina – Winston-Salem – Wake Forest University

Rhode Island – Providence – 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 Sciences Center

Texas – Houston-Pouzar – Centex Studies, Inc.

Texas – Houston-Westfield – Centex Studies, Inc.

Texas – Kingsville – Texas A&M Health Sciences Center

Texas – McAllen – Centex Studies, Inc.

Virginie – 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 United States National Institutes of Health to respond to the global pandemic. Through CoVPN, NIAID is leveraging the infectious disease expertise of its existing research networks and global partners to address the urgent need for SARS-CoV-2 vaccines and antibodies. CoVPN will work to develop and conduct studies to ensure rapid and in-depth 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 the Fred Hutchinson Cancer Research Center, home to three Nobel Laureates, interdisciplinary teams of world-renowned scientists are researching new and innovative ways to prevent, diagnose and treat cancer, HIV / AIDS and other deadly 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. Seattle-based, independent, nonprofit research institute, Fred Hutch is home to the nation’s premier cancer prevention research program, as well as the Women’s Health Initiative’s Clinical Coordinating Center and the international headquarters of the HIV Vaccine Trials Network and from the COVID-19 Prevention Network.

Media contacts

Anna altavas

425-275-7408

[email protected]

Claire Hudson

206-919-8300

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