The University of Wisconsin School of Medicine and Public Health has been selected as one of the sites for the KidCOVE study, a phase three clinical trial to evaluate the safety and effectiveness of the Moderna COVID-19 vaccine in children.
The study is taking place at the American Family Children’s Hospital in Madison, and enrollment for a limited number of children, ages 6 months to 11, will begin August 13. Enrollment at the Madison location is very limited and strictly determined by age and medical fitness as defined by Moderna.
The Moderna vaccine is given in two doses, four weeks apart. The participants were grouped into three age categories: 6 months to under 2 years; 2 years to under 6 years; and 6 years to under 12 years. Researchers plan to enroll approximately 4,000 children in each group, spread across 75 to 100 study sites in the United States and Canada.
Participation in the study lasts 14 months, with at least four follow-up appointments during that time. To participate in the clinical trial, children will be screened through medical examination and review of medical records to ensure they are in good health. All participants must be at least 6 months to less than 12 years old at the time of the first screening visit. This is a placebo-controlled study, which means that participants receive either the vaccine or the placebo. Participants don’t know which one to get.
A nurse prepares a measured syringe dose of the Moderna COVID-19 vaccine at the University of Wisconsin-Madison. Photo by Jeff Miller / UW-Madison
If a potential participant has a chronic disease, such as asthma or diabetes, the disease should be under stable control at the time of screening. Participant must not have had or been exposed to anyone with COVID-19 in the two weeks prior to receiving the first dose of vaccine.
“Getting kids vaccinated will help protect everyone and move us closer to mitigating this pandemic,” said William Hartman, MD, PhD, co-principal investigator of the KidCOVE study at UW. “This vaccine is identical to the vaccine given to adults today, but this trial will help us determine the right dosage for children.”
To date, more than 4 million children have contracted COVID-19 and more than 300 have died. Although survival rates for children are higher than for adults, it is clear that this virus can still harm children and they can pass COVID-19 on to other people, including the elderly and other vulnerable members of the community who are at higher risk. to a serious illness, Hartman said.
“UW has participated in some of the most important studies to treat and prevent this disease, which protects the people of Wisconsin and beyond,” he said. “Testing and understanding the safety and efficacy of these treatments and vaccinations has a global impact and is one of the best contributions we can make to help end this pandemic.”
James Conway, MD, professor of pediatrics in the UW School of Medicine and Public Health and UW Health pediatric infectious disease physician and medical director of the UW Health immunization program, is a co-principal investigator of this study.
If you are interested in enrolling your child in the study, please visit www.kidcovestudy.com or call 608-262-8300.