LEXINGTON, Ky. (June 16, 2021) — The University of Kentucky is one of 90 sites in the U.S. and 10 sites in Canada selected to participate in KidCOVE, a national trial by Moderna to test the safety and effectiveness of its COVID-19 vaccine in children age 6 months through 11 years old. The vaccine, called mRNA-1273, may protect young children from getting sick if they come into contact with SARS-CoV-2, which causes COVID-19.
A vaccine that prevents COVID-19 disease and SARS-CoV-2 virus transmission among children will be a crucial public health tool in curbing the pandemic. Using its vaccine currently given to adults, Moderna has committed to researching a safe and effective vaccine to protect people of all backgrounds and ages, including children less than 12 years of age. This pediatric research study will define an age-appropriate dose, test the vaccine’s effectiveness, and monitor any potential side effects in children, collecting information to ensure safe use.
The KidCOVE trial will enroll 7,050 children nationwide, staggering the recruitment of three different age groups. The first age group will enroll children between the ages of 6 years to less than 12 years old. The second age group to enroll will be children between the ages of 2 years to less than 6 years old. The third and final group will be ages 6 months to less than 2 years old. Part 1 of the study will determine the dose with 1,350 children and part 2 will determine effectiveness with 5,700 children.
UK will enroll up to 200 children to receive either two doses of the mRNA-1273 vaccine or a placebo, 28 days apart, and will be monitored for up to 14 months via phone calls, telemedicine visits and up to seven visits to the pediatric research clinic at UK HealthCare – Turfland. Participants are compensated.
The UK study is led by Dr. George J. Fuchs III, chief of pediatric gastroenterology and vice chair of clinical affairs in the Department of Pediatrics at UK HealthCare’s Kentucky Children’s Hospital. Other investigators for the study include providers from the divisions of pediatric gastroenterology, pediatric pulmonary, allergy and immunology, internal medicine and pediatrics, neonatology, and general pediatrics.
“We are privileged for 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 help bring an end to this pandemic.”
Parents or guardians interested in enrolling their child in the KidCOVE study can visit UK’s website at www.StopCOVIDKy.com, where they can answer a confidential pre-screening survey to help determine if a child qualifies and for what phase of the study.
Answering the survey does not obligate you or your child to participate. Please note that interest in this study might exceed enrollment capacity, and it could take several weeks for the study team to contact you.
Funding for this research at 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).
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