From Indiana University — Bloomington:
Indiana University Bloomington has been selected as a study site and is enrolling participants for a new clinical trial that will evaluate whether the Moderna COVID-19 vaccine prevents infection and spread of the virus among college students and their close contacts.
The clinical trial, called Prevent COVID U, is funded by the federal COVID-19 Response Program and the National Institute of Allergy and Infectious Diseases. The randomized, open-label, controlled study is led by researchers at Fred Hutchinson Cancer Research Center, where the National Institutes of Health’s COVID-19 Prevention Network is headquartered.
Researchers will enroll approximately 12,000 college students age 18 to 26 at more than 20 universities nationwide and follow them over a five-month period.
The IU Bloomington study site is led by Molly Rosenberg and Christina Ludema of the IU School of Public Health-Bloomington and Dr. Aaron Ermel of the IU School of Medicine. The research team’s findings will help scientists answer key questions about life post-vaccination, which will inform science-based decisions about mask use and social distancing for fully vaccinated people.
“I am excited about having IU be able to contribute to a study that is of such critical scientific importance,” said Rosenberg, an assistant professor at the School of Public Health-Bloomington and a member of IU’s COVID-19 mitigation testing team. “We know that we have a growing arsenal of vaccines that are extremely effective at preventing COVID-19 disease and death. But we don’t know whether any of these vaccines, including the Moderna vaccine, prevent asymptomatic transmission. Before we can ‘return to normal’ after vaccination, this question needs to be answered.”
Study participants will be randomly split into two groups. The first group will be vaccinated immediately, and the second group will be vaccinated four months later. Both groups will receive the required two doses of the Moderna COVID-19 vaccine, mRNA-1273, which was authorized by the FDA in December for emergency use in the U.S., administered 28 days apart. Participants will complete questionnaires with an electronic diary app, swab their nose daily to test for COVID-19 infection, and provide periodic blood samples.
People identified by study participants as their close contacts will also play an integral role in the study, as they will also be tested for COVID-19 infection, and the degree of COVID-19 transmission from vaccinated people will be determined by the infection rate in these close contacts.
Ludema, also an assistant professor in the School of Public Health-Bloomington, said the IU research team hopes to recruit a diverse population of IU Bloomington students for the study.
“We would love to have students from all parts of IU Bloomington’s student body participate in the trial,” Ludema said. “It is critically important for science, and for health equity, that randomized trial participants reflect the diversity of the places they are recruited from. We are working with a dedicated undergrad advisory board to identify good recruitment strategies to reach all student population groups, and would like to encourage any student who is interested and eligible to consider participating.”
IU Bloomington students interested in participating in the clinical trial can learn more, including eligibility requirements, and sign up for potential enrollment through the study’s website.
“We have heard from IU students that the COVID-19 pandemic has often made them feel disempowered and helpless,” Rosenberg said. “It is our hope that this study will provide at least some of our IU students the opportunity to be more active contributors in the fight.”
Other key members of the IU research team are Drs. Aaron Carroll, Lana Dbeibo and Kathy Hiller, all of the IU School of Medicine; Mary Lynn Davis-Ajami of the IU School of Nursing; and Dr. Beth Rupp of the IU Student Health Center.
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