Researchers at the University of Maryland School of Medicine (UMSOM) on April 27 began enrolling children ages 6 months to 11 years old in a clinical trial of the Moderna mRNA-1273 COVID-19 vaccine, which has already received Food and Drug Administration emergency use authorization to prevent COVID-19 in people ages 18 and older.
The study, called KidCOVE, will assess the safety and immunogenicity of mRNA-1273 in a pediatric population. The trial is being conducted in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
James Campbell, MD, MS, and Karen Kotloff, MD
UMSOM is one of multiple sites in the U.S. and Canada that will enroll approximately 6,750 children in two phases. Participants will receive two doses 28 days apart. The UMSOM site is expected to enroll 120 children.
The vaccine trial is being conducted by researchers in UMSOM’s Center for Vaccine Development and Global Health (CVD) as part of their NIAID-funded Vaccine and Treatment Evaluation Unit (VTEU) work. It adds to the extensive COVID-19 vaccine research that has been underway on campus since spring 2020.
James Campbell, MD, MS, professor of pediatrics, is the principal investigator at the UMSOM site, which will enroll participants in Baltimore and Frederick, Maryland. Karen Kotloff, MD, professor of pediatrics, associate director for clinical research in CVD and principal investigator of the VTEU; Andrea Berry, MD, assistant professor of pediatrics; Elizabeth Hammershaimb, MD, postdoctoral fellow, and other CVD experts also serve as investigators in this study.
“Children are not small adults. Medical research is very much needed to understand how best to keep them safe from a global pandemic that has killed so many,” Campbell said. “We hope KidCOVE will provide much-awaited information to accomplish just that.”
Healthy boys and girls and children with stable chronic medical conditions will be considered for inclusion in KidCOVE. Study participation includes phone calls, telemedicine visits, and up to seven in-person visits to the study site.
“The KidCOVE study builds on the strong foundation of the CVD team through our ground-breaking work on the adult clinical trials of COVID-19 vaccines,” Kotloff said. “Collectively, we are at the forefront of the fight against the COVID-19 pandemic. The inclusion of children in these studies is long overdue, and we are pleased to be part of these efforts.”
UMSOM’s participation in KidCOVE marks its first testing of a pediatric vaccine for COVID-19. CVD’s careful, meticulous work on the Pfizer, Moderna, and Novavax COVID-19 vaccine clinical studies, and its many decades of work with pediatric vaccines, led to this milestone.
“Our Center for Vaccine Development and Global Health continues to lead the way in conducting COVID-19 trials,” said E. Albert Reece, MD, PhD, MBA, executive vice president for medical affairs, University of Maryland, Baltimore, and the John Z. and Akiko K. Bowers Distinguished Professor and dean at UMSOM. “This trial is critical in helping to protect children, who remain vulnerable until we develop and test safe, effective vaccines.”
The UMSOM VTEU is funded by federal contract No. 75A50120C00034. BARDA is reimbursing Moderna for 100 percent of the allowable costs incurred by the company for conducting the program described in the contract. The U.S. government has agreed to purchase supply of mRNA-1273 under U.S. Department of Defense contract No. W911QY-20-C-0100.