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. 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."
Dr Larry Corey, Study Leader and Study Principal Investigator of CoVPN's Operations Program, Professor, Fred Hutchinson Cancer Research Center
"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.