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. Led by Dr. Hong Van Tieu and supported by site coordinator Sauda Muhammad and sub-investigator and community engagement lead Dr. Jorge Soler, Project ACHIEVE at the New York Blood Center is a study site and has been actively enrolling participants into the study.
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).
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.
More than 40 sites including universities, health care centers, and community organizations across the U.S. will participate in the expanded 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 or completing our Project ACHIEVE’s online screener preventcovidunyc.org.