UK will be clinical vaccine trial for children ages 6 months to 11 years
The University of Kentucky has been chosen as one of the sites for an international clinical trial to help develop a COVID-19 vaccine for children from six months through 11 years of age, it was announced on Wednesday.
The KidCOVE trial will involve the Moderna vaccine, which is already available for those 12 and older, and UK has joined the second phase of a three-phase trial to determine the safety and efficacy of the vaccine for younger children.
Dr. George Fuchs, professor and chief of pediatric gastroenterology and vice-chair of clinical affairs for the department of pediatrics, Kentucky Children’s Hospital, is the principal investigator of the study. He said the study will have two components.
“The first part is a dose finder part of the study,” he said. “Different doses in the different ages of these children will be tested. The antibody response will be assessed in looking for the level needed to protect against COVID-19, based on what we know from the adult studies.”
There will only be about seven to ten children involved in that phase of the study.
“That second part will include a few thousand children,” Fuchs stated. “We anticipate enrolling anywhere from 150 to 200 children, and perhaps more, depending on how many children have been enrolled at that point.”
He said they feel comfortable with participating in the trial, due to the experience of the Moderna vaccine in adolescents and adults. “The technology is really quite amazing, and it’s one of the safest vaccines that have ever been developed.”
Fuchs noted the trial involving younger children is important. “In order to get maximum herd immunity, we’ve got to get the children vaccinated.”
Dr. John Baur, co-investigator and professor of pediatrics and neonatology at UK, said there will be two windows of enrollment. “A very small number of children age six months up to two years will participate during a brief window during the third week of June. Then we’ll have more open access for children ages six months to 12 years in the second half of July.”
The two vaccinations, just like for teens and adults, will be given 28 days apart, and the larger trial will involve 75% of the participants given the Moderna vaccine, while the rest will receive a placebo.
“This is the gold standard to ensure that we know whether or not we know this vaccine works,” Fuchs said. “Participants will not know if they get the vaccine or the placebo.”
To find out more about the study and its requirements, as well as to register as a participant, you can go to stopcovidky.com/pediatric/.