A national study of the effectiveness of the Moderna vaccine ultimately involving as many as 12,000 U.S. college students is underway. The “Prevent COVID U” is intended to answer whether the Moderna Covid-19 vaccine, which has been shown to protect against serious symptoms in infected individuals, also prevents those who get infected from spreading the disease to others.
The study is designed and managed by researchers at the CoVPN, or COVID-19 Prevention Network, headquartered at Seattle’s Fred Hutchinson Cancer Research Center. It is supported by the National Institute of Allergy and Infectious Diseases, headed by Dr. Anthony Fauci.
Larry Corey, the former director of the Fred Hutchinson Cancer Research Center and a lead investigator on the study, said that planning for the investigation began back in December when it was known that both the Pfizer and Moderna vaccines were effective in stopping symptomatic disease, but it was still not clear whether vaccinated people could become infected, be asymptomatic, and unknowingly spread the virus to others.
“We needed a different kind of study design — one that uses intensive sampling of the nose, the site of first infection, and can detect the exact time-course of infection,” Corey said.
Study volunteers (who must be between the ages of 18-26, not previously vaccinated, and in good health) will be administered the Moderna COVID-19 vaccine. Half of the volunteers will randomly be assigned to receive the Moderna vaccine immediately, while the other 6,000 students will receive it four months later. They will also be expected to:
- swab their noses every day for four months during the course of the clinical trial. Those swabs — more than 1.3 million in total — will be sent weekly to a laboratory for testing to determine if a participant is infected with SARS-CoV-2,
- complete daily questionnaires via an app throughout the study,
- receive twice weekly COVID-19 tests from their college health clinics so that, if they test positive for the virus, they can quickly be isolated and treated.
- give periodic blood samples,
- identify the names of “close contacts” – friends, co-workers or housemates – who are the people most likely to be exposed if a participant becomes infected. Researchers hope to sign up approximately 25,000 close contacts, each of whom will be asked to monitor their health weekly on an electronic diary, submit two blood tests, take daily nasal swabs for two weeks, and undergo routine screening for Covid-19 infection by their university. In the event a participant in the primary study tests positive, their contacts will be notified and provided kits for two weeks of self-testing so that an infection can be detected quickly.
Enrollment in the study began at 21 U.S. college campuses last week. The participating universities are:
Charles Drew University
Indiana University – Bloomington
Stony Brook University
Texas A&M – College Station
Texas A&M – Kingsville
University of Arizona
University of California – San Diego
University of Colorado – Boulder
University of Florida – Gainesville
University of Illinois – Urbana-Champaign
University of Kentucky
University of Maryland – College Park
University of Nebraska
University of North Carolina
University of Virginia
University of Washington
Wake Forest Baptist Health
West Virginia University
Volunteers will be paid varying amounts depending on the cost of living at their location. At the University of Virginia, which hopes to sign up 600 volunteers, they will be paid up to $590 each, broken up into monthly payments, and the “close contacts” who enroll in the study will receive $100 to $250. At the University of Illinois, a volunteer can make up to $997 for study participation.
Commenting on the significance of the study at the White House last week, Dr Fauci described it as “a question of extreme importance because we know when people are vaccinated, that the endpoint of the trial showed that they were protected against clinically apparent disease. But the prevailing question is: When these people get infected, how often is that? If they’re asymptomatic, how much virus do they have in their nose and do they transmit it to people who are their close contacts? Again, this will help inform science-based decisions about mask use and about social distancing post vaccination.