The COVID-19 Prevention Network (CoVPN), headquartered at the Fred Hutchinson Cancer Research Center, has announced the launch of Prevent COVID U, a new study to evaluate SARS-CoV-2 infection and transmission in college students who are familiar with the Moderna COVID-19 vaccine was vaccinated with mRNA-1273.
The study is funded by the federal COVID-19 response program and the National Institute for Allergies and Infectious Diseases (NIAID). Its purpose is to determine whether the mRNA-1273 vaccine currently approved for emergency by the U.S. Food and Drug Administration will prevent infection with SARS-CoV-2 (including an asymptomatic infection), limit the virus in the nose, and limit its transmission of SARS-CoV-2 can limit the virus from vaccinated people to their close contacts.
“This study builds on the Phase III COVID-19 clinical trials that tested the ability of vaccines to prevent symptomatic and severe COVID-19 disease in adults. The new study will tell us if a person can become infected after vaccination and if the vaccine will prevent the virus from spreading from person to person, ”said Dr. Larry Corey, Principal Investigator of the CoVPN Surgical Program, Professor at the Fred Hutchinson Cancer Research Center and one of the lead investigators. “The answers to these questions have public health implications and enable us to make science-based decisions about mask use and social distancing after vaccination – especially as new variants emerge.”
A large number of SARS-CoV-2 infections have been reported in locations across the United States. A nationwide survey showed that more than 397,000 infections were counted at more than 1,800 universities after the reopening in autumn 2020.
The Prevent COVID U study is a randomized, open, controlled study. Investigators will enroll approximately 12,000 college students ages 18-26 in more than 20 universities in the United States and follow them over a period of five months. In the two-armed study, half of the students are randomly selected to receive the vaccine immediately upon enrollment, while the other half receive the vaccine four months later. All participants know what part of the study they are in when they enroll, and they all ultimately get the vaccine. During the entire study period, the participants fill out questionnaires via an eDiary app, dab their noses daily for a COVID-19 infection and regularly provide blood samples.
Because testing the effectiveness of the vaccine in reducing and / or preventing transmission requires measuring the spread of the virus to other people, approximately 25,500 people identified as “close contacts” by participants in the main study will also be eligible to participate invited to the study. Close contacts who have agreed to participate in the study are asked to answer weekly questionnaires via eDiary, provide two blood samples and take nasal swabs daily for two weeks.
“We hope to show that COVID-19 vaccines will prevent people from getting coronavirus in the first place and that it will stop transmission to others,” Corey said. “The emphasis on the close contacts among the students who acquire COVID-19 in the study is one of the most unique aspects of the study.”
Universities participating in the study include Charles Drew University, Clemson University, Indiana University in Bloomington, Morehouse School of Medicine, Northwestern University, Stony Brook University, Texas A&M College Station, Texas A & M Kingsville, University of Arizona and University of California at San Diego by Colorado Boulder, University of Florida at Gainesville, University of Illinois at Urbana-Champaign, University of Kentucky, University of Maryland in College Park, University of Nebraska, University of North Carolina, University of Virginia, University of Washington, Wake Forest, West Virginia University, and Winston-Salem State University.
Edited by Gary Cramer