MUSC participating in COVID-19 vaccine clinical trials for juveniles

CHARLESTON, S.C. (WCBD) – As teenagers across the country are being vaccinated to prevent the spread of COVID-19, clinical trial research is underway for children six months to seventeen-years-old.

Lowcountry doctors are helping to put the pieces together to complete the herd immunity puzzle.

The Medical University of South Carolina is one in a group of research sites across the country leading a COVID-19 vaccine pediatric trial here in the Lowcountry. 

“Every state’s population is 20-25 percent children, so if you don’t have any opportunity to vaccinate children, it’s virtually impossible to get to herd immunity,” said Dr. Andy Atz, chair of MUSC’s Department of Pediatrics. 

Dr. Atz serves as principal investigator for the KidCove study at MUSC. 

“The ability to do COVID vaccine trial in small children ages six months to 12 years, just starting to get underway,” said Dr, Atz. “Approximately a hundred sites have been selected for the Moderna trial and MUSC is one of those one hundred in North America.”

Seven other physicians are part of the investigator team, and there are eight to twelve study coordinators that will devote time to running the study overall. 

Atz says, “The trial itself is incredibly complicated, specifically meant to be very safe for children, so it has a very slow ramp up.  We have not started giving vaccines out yet, but we will be part of the hundred that will be able to give lots of vaccines come this summer.”

Selected sites are tapped for specific phases, and hundreds of families are interested.

“Through almost word of mouth, we’ve been able to attract hundreds of interested families. I think our issue is not going to be that we don’t have enough interested parties, our issue maybe that we have far more interest than we may be able to ultimately enroll in the study.”

At some point during the lengthy trial, more than 6,000 children will be enrolled, during thirteen phases, different age groups at different dosages.

During the first phase, different doses are tested in three separate age groups: six months to two years; Two years to six years, that’s just before school age; and six-to-twelve-year old’s who are prime school age children. 

Dr. Atz says, “The data is looked at for safety.  If there are considerably any issues with safety, then the trial stops. I think the other thing we can give to families, is that this is really set up in a way if there is a safety concern the whole study stops.  Thus far, across the site, there have only been seventy-five children enrolled, predicated on doing this very slow, with one dose in this one particular group thus far.”

MUSC will conduct the study at their remote site at Summey Medical Pavilion in North Charleston.

As to the length of the study, “That is another fascinating thing because it involves three age groups. The study right now is projected to ultimately take about a year from now to completely be done,” Atz said.

Study participants do receive compensation, $100 per office visit. Atz says, “People will not get rich with this. The idea of patient compensation for a study that require you to come in person for a visit, it’s very common in both adult research and pediatric research.”

Coastal Carolina Research Center is also participating in pediatric COVID studies.

Dr. Cynthia Strout is principal investigator. “We have two studies coming up. One is with Johnson and Johnson, and the other is with Nova-Vax. Both will be starting in a few weeks. Between the two studies in the United States, it will be between three or four thousand, but at our site, it will be about a hundred.  We actually had a lot of parents from our adult study say they would like their children to participate.  We do have a list already of people who are interested,” she said. 

Participants receive $150 per office visit.

One of the studies is fifteen months, the other is two years.  Strout says, “There’s quite a bit of oversight, lot of monitoring along the way that helps keep volunteers safe.” 

She says, while there is always a chance of an adverse reaction during clinical trials, the benefits to finding a safe vaccine for children far outweighs the risk. 

“Vaccinating kids is part of the puzzle that needs to be figured out to help get us back to our normal life. It’s one of the things that will help us get to the end of this pandemic.  I’m very thankful for the people that stepped up to volunteer for those studies because that’s the data used to get those vaccines approved, and they’re now saving lives,” she said.

For more information on these clinical trials, call MUSC at 843-792-2300.  You can call Coastal Carolina Research Center at 843-856-3784.