Recently, the University of Kentucky became one of 90 trial sites in the U.S. accompanied by 10 comparable centers in Canada to participate in Moderna’s national trial targeting children aged 6 months old to 11 years old. Called KidCOVE, the study investigates the use of the COVID-19 vaccine called mRNA-1273 in an effort to evaluate whether the experimental mRNA-based vaccine candidate, currently authorized on an emergency basis for adults, can protect young children from SARS-CoV-2 related illness. Although there’s a growing societal debate about whether healthy children should be vaccinated at all for COVID-19, biotech company Moderna now embarks down the pathway to determine an age-appropriate dose, as well as evaluate the vaccine’s effectiveness while monitoring any and all side effects in children. Does vaccination make sense as a public health tool for young healthy children?
Recently showcased in the University of Kentucky News, Moderna now works through the 100 trial sites to enroll 7,050 children across North America to commence the study. The study staggers the age cohorts across three study groups, including 1) 6 years to less than 12 years old, 2) 2 years old to less than 6 years old, and 3) 6 months old to less than 2 years old.
The study’s first part involves 1,350 children and will focus on the establishment of an appropriate dose in the children. The second group centers on effectiveness and involves 5,700 children.
The study involves two doses of the mRNA-1273 vaccine or a placebo, administered 28 days apart. The children are thereafter monitored for 14 months via direct phone call, telemedicine visits, and up to seven on-site visits at the pediatric research clinic at UK HealthCare—Turfland.
This particular trial site is targeting the enrollment of 200 children, meaning it’s enrolling more than the average number of participating children. Note that participants (e.g. their parents) are compensated.
Who is Funding this Study?
Funding for this research in the UK is provided by a partnership of the National Institute of Allergy and Infectious Diseases (NIAID), Biomedical Advanced Research and Development Authority, and ModernaTx. Additional support is provided by the KCH Office of Pediatric Research, the UK Center for Clinical and Translational Research (CCTS), and the UK Clinical Research Support Office (CRSO).
The Lead Investigator
Dr. George J. Fuchs III leads the study for the University of Kentucky. Dr. Fuchs III serves as the chief of pediatric gastroenterology and vice-chair of clinical affairs at UK Healthcare’s Kentucky Children’s Hospital, Department of Pediatrics.
Discussing the study, Dr. Fuchs reported, “We are privileged for the UK to be selected as a site for this important trial,” Fuchs said. “With all other age groups currently eligible for vaccination, it’s vital that we extend this to young children, which is critical to their own protection and to facilitate herd immunity in order to bring an end to this pandemic.”
TrialSite notes that there are at least some physicians that question the ethos of vaccinating young children, especially young healthy children. For example, in what is deemed a mainstream online medical website MedPage Today’s top editor recently suggested that perhaps healthy children should be spared the jab.
University of Kentucky
The University of Kentucky is increasingly the first choice for students, faculty and staff to pursue their passions and their professional goals. In the last two years, Forbes has named the UK among the best employers for diversity, and INSIGHT into Diversity recognized us as a Diversity Champion four years running. The UK is ranked among the top 30 campuses in the nation for LGBTQ* inclusion and safety. UK has been judged a “Great College to Work for” three years in a row, and the UK is among only 22 universities in the country on Forbes’ list of “America’s Best Employers.” We are ranked among the top 10 percent of public institutions for research expenditures — a tangible symbol of our breadth and depth as a university focused on discovery that changes lives and communities. And our patients know and appreciate the fact that UK HealthCare has been named the state’s top hospital for five straight years. Accolades and honors are great. But they are more important for what they represent: the idea that creating a community of belonging and commitment to excellence is how we honor our mission to be not simply the University of Kentucky, but the University for Kentucky.
Call to Action: Interested in learning more about this study? Check out the study website here to learn more.