This Phase 2/3 Trial Will Test the Vaccine in Children Ages 6 Months to 11 Years
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 (FDA) Emergency Use Authorization (EUA) to prevent COVID-19 in people ages 18 years 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, part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
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,” Dr. 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, UM 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.
About the Moderna COVID-19 Vaccine
The Moderna COVID-19 Vaccine is an mRNA vaccine against COVID-19, co-developed by Moderna and the NIAID Vaccine Research Center. It received Emergency Use Authorization from the U.S. FDA in December 2020 for adults ages 18 years or older.
About the University of Maryland School of Medicine
Now in its third century, the University of Maryland School of Medicine was chartered in 1807 as the first public medical school in the United States. It continues today as one of the fastest growing, top-tier biomedical research enterprises in the world -- with 45 academic departments, centers, institutes, and programs; and a faculty of more than 3,000 physicians, scientists, and allied health professionals, including members of the National Academy of Medicine and the National Academy of Sciences, and a distinguished two-time winner of the Albert E. Lasker Award in Medical Research. With an operating budget of more than $1.2 billion, the School of Medicine works closely in partnership with the University of Maryland Medical Center and Medical System to provide research-intensive, academic and clinically based care for nearly 2 million patients each year. The School of Medicine has more than $563 million in extramural funding, with most of its academic departments highly ranked among all medical schools in the nation in research funding. As one of the seven professional schools that make up the University of Maryland, Baltimore campus, the School of Medicine has a total population of nearly 9,000 faculty and staff, including 2,500 student trainees, residents, and fellows. The combined School of Medicine and Medical System (“University of Maryland Medicine”) has an annual budget of nearly $6 billion and an economic impact more than $15 billion on the state and local community. The School of Medicine, which ranks as the 8th highest among public medical schools in research productivity, is an innovator in translational medicine, with 600 active patents and 24 start-up companies. The School of Medicine works locally, nationally, and globally, with research and treatment facilities in 36 countries around the world. Visit medschool.umaryland.edu
About the Center for Vaccine Development and Global Health
For over 40 years, researchers in the Center for Vaccine Development and Global Health have worked domestically and internationally to develop, test, and deploy vaccines to aid the world’s underserved populations. CVD is an academic enterprise engaged in the full range of infectious disease intervention from basic laboratory research through vaccine development, pre-clinical and clinical evaluation, large-scale pre-licensure field studies, and post-licensure assessments. CVD has worked to eliminate vaccine-preventable diseases. CVD has created and tested vaccines against cholera, typhoid fever, paratyphoid fever, non-typhoidal Salmonella disease, shigellosis (bacillary dysentery), Escherichia coli diarrhea, nosocomial pathogens, tularemia, influenza, malaria, and other infectious diseases. CVD’s research covers the broader goal of improving global health by conducting innovative, leading research in Baltimore and around the world. CVD researchers are developing new and improved ways to diagnose, prevent, treat, control, and eliminate diseases of global impact. Currently, these diseases include typhoid, Shigella, E. coli diarrhea, malaria, and other vaccine-preventable infectious diseases. CVD researchers have been involved in critical vaccine development for emerging pathogens such as Ebola and Zika. In addition, CVD’s work focuses on the ever-growing challenge of antimicrobial.