UMass Medical School researchers are about to start enrolling adolescents ages 12 through 17 in a clinical trial to test the COVID-19 mRNA vaccine made by Moderna. The vaccine has already been authorized for emergency use in adults 18 years or older by the U.S. Food and Drug Administration. This is the first it is being tested in a younger population.
Moderna expects to enroll 3,000 adolescents at up to 15 sites nationwide. Enrollment in the trial, called TeenCove, is expected to start at the Medical School in early February. Adolescents and their families can visit the website for more information and to indicate their interest in participating.
鈥淐hildren鈥檚 responses to vaccines can differ from those in adults,鈥 said principal investigator , MD, the UMass Memorial Health Care Chair in Biomedical 性闻联播; vice provost for clinical and translational research; professor of molecular medicine, pediatrics and medicine; and director of the UMass Center for Clinical and Translational Science. 鈥淭he goals of the trial are to evaluate the safety profile of the vaccine, to see whether adolescents make the same level of immune responses that were observed in adults and to see whether the vaccine protects against illness or infection.鈥
Other key investigators are Nisha Megan Fahey, DO, instructor in pediatrics, and Lawrence M. Rhein, MD, MPH, the Stoddard Chair of Pediatrics, and chair and associate professor of pediatrics. The study team also includes Christina R. Hermos, MD, MMSc, assistant professor of pediatrics; Patricia McQuilkin, MD, professor of pediatrics; and Fei Jamie Dy, MD, assistant professor of pediatrics.
Dr. Luzuriaga said study participants will receive either vaccine or placebo (saline) in a 2:1 ratio. Those receiving vaccine will receive 2 doses of 100 micrograms each, given 28 days apart, as is authorized for adults. Participants will be followed up for one year following receipt of the second dose.
性闻联播ers are trying to enroll teen participants broadly from across the community, particularly underserved racial and ethnic minorities that are most affected by COVID-19.
Luzuriaga said they will recruit from UMass Memorial clinics and are actively engaging with community partners in recruiting and enrolling study participants.
The study will be conducted at the UMass Center for Clinical and Translational Science Clinical 性闻联播 Center in the Ambulatory Care Center on the University campus.