UNMC, Children’s participate in national COVID-19 vaccine clinical trial

The University of Nebraska Medical Center (UNMC) and Children’s Hospital & Medical Center are part of the nationwide COVID-19 Prevention Network (CoVPN), which recently launched a clinical trial called Prevent COVID U. The study will evaluate SARS-CoV-2 infection and transmission among college students at the University of Nebraska at Omaha (UNO) who receive the Moderna COVID-19 vaccine, mRNA-1273.

The Prevent COVID U study, which opened initial study sites March 25, is a randomized, open-label, controlled study. Investigators will enroll approximately 12,000 college students aged 18-26 at 22 universities across the U.S. and follow them over a five-month period. The study is funded by the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health (NIH).

In the two-arm trial, half of the students will be randomly selected to receive the vaccine right after enrollment, while the other half will get the vaccine four months later. The study may be ideal for volunteers who know they want to get the vaccine eventually, but either prefer to wait or have no preference on timing. All participants will know which arm of the trial they are in at enrollment and all will ultimately receive the vaccine. Throughout the study period, participants will complete questionnaires via an eDiary app, swab their nose daily (a self, less invasive swab) for COVID-19 infection and provide periodic blood samples.

The trial, funded by the federal COVID-19 Response Program and the NIAID, is designed to determine if the mRNA-1273 vaccine, currently authorized for emergency use by the U.S. Food and Drug Administration, can prevent infection with SARS-CoV-2 (including asymptomatic infection), limit virus in the nose and reduce transmission of the virus from vaccinated persons to their close contacts.

“We know that vaccines are effective at reducing severe disease and death from COVID-19,” said Jasmine Marcelin, MD, assistant professor in the UNMC Department of Internal Medicine Division of Infectious Diseases and Nebraska Medicine physician, who is one of the co-principal investigators leading the nationwide study. “The vaccine trials that have been performed so far were not designed to answer the question specifically about prevention of transmission from people with asymptomatic infection, as they lacked daily swabbing and contact tracing components.

“The Prevent COVID U study is exciting because it will be the first of its kind to use this strategy to answer this question, and with this answer, we will be able to inform the policies needed to get folks into a post-COVID era safely. By participating in this study, UNMC and the university students volunteering to enroll are contributing to history and should be congratulated for the role they play in moving us through this pandemic,” Dr. Marcelin said.

Large numbers of SARS-CoV-2 infections have been reported on campuses throughout the U.S. A nationwide survey found that more than 397,000 infections were counted at 1,800-plus universities after reopening in the fall of 2020. Two separate studies in the CDC’s Morbidity and Mortality Weekly Report last October reported that SARS-CoV-2 infections among young people aged 18-22 increased 55% nationally between August and September 2020. Between June and August 2020, young people aged 20-29 had the highest incidence of SARS-CoV-2 infection in the U.S. – accounting for more than 20% of all confirmed cases.

Because testing the vaccine’s effectiveness to reduce and/or prevent transmission requires measuring spread of the virus to others, about 25,500 individuals identified by participants in the main study as “close contacts” also will be invited to take part in the trial. Close contacts who have agreed to participate in the study will be asked to answer weekly questionnaires via eDiary, provide two blood samples and take daily swabs of their nose for two weeks.

UNMC and Children’s Hospital & Medical Center’s Russell McCulloh, MD, will lead the UNMC study.
“We know that COVID vaccines protect the people who receive them from getting sick or dying from the disease, but we don’t know whether people who get vaccinated can still transmit the virus to other people,” said Dr. McCulloh, UNMC associate professor and chief of the division of pediatric hospital medicine for UNMC and Children’s. “This study focuses on young adults, who often don’t have symptoms of COVID which makes them a higher risk for transmitting the virus without knowing they have it.

“This study is so important because it will tell us if a person who gets vaccinated can still transmit the virus, which can impact school attendance decisions and use of protective health measures. Additionally, we will be enrolling hundreds of college students to get the Moderna vaccine in our area, which will directly benefit these students and our community.”

For more information about the UNMC study, email covpn3006@unmc.edu.