A research center in southern Nevada is looking for children ages 12-17 for a clinical trial to test the effects of a new COVID-19 vaccine on that age group.
The Wake Research-Clinical Research Center in Nevada is enrolling young participants in a study of the Novavax vaccine, which is expected to be the fourth emergency approved vaccine in the United States
Despite the evidence that the vaccine is effective and with no major side effects, finding teenagers for the study could be challenging, said the study’s lead investigator.
Parents “may be reluctant to put their children in a study that results in blood draws and discomfort,” said investigator Dr. Michael Levin, a Henderson pediatrician. Not only the parents, but also the children themselves have to be ready.
Sixth grader Trent Thurman said he didn’t need to be talked into participating in the study by his father Wesley, who was participating in a local study with the Moderna COVID-19 vaccine.
“I want to get the vaccine,” said Trent, who is 12 years old. Why? “So I can be sure and that other people can be safe.”
Does he mind getting a shot? “No, not really,” said the Mannion Middle School student.
Vaccine or placebo?
Participation in the study includes taking two doses of the actual vaccine or a saltwater placebo three weeks apart, plus follow-up exams, blood tests, and phone calls at check-in.
Six months after receiving the recordings, those given the placebo will receive the actual vaccine in a “blinded crossover,” meaning participants will not be informed whether they originally received the vaccine, Novavax said in a press release on Monday about the study. Participants will be monitored for up to two years after their final dose.
The company is looking for up to 3,000 young people to participate in the study at 75 locations across the country, the press release said.
According to Levin, 60 to 100 participants will take part in the local study.
Clinical trial participants receive financial compensation, typically $ 1,000 or less, said Levin, who did not provide an exact figure.
To be eligible, an adolescent must be in stable health and any disease treated well, he said. Those who have autoimmune diseases or a weakened immune system are not good candidates. Anyone who has tested positive or has already been vaccinated against COVID-19 is not eligible.
Late-stage clinical studies in the UK showed that, according to the Maryland-based biotech company, the Novavax vaccine is almost 90 percent effective against the coronavirus and 86 percent against the British strain or variant B.1.1.7. A phase-phase clinical study in South Africa showed that the vaccine was 100 percent effective against serious illnesses, but 49 percent effective against disease prevention by a variant that defies immunity, B.1.135, first introduced in this one Land was discovered.
A more traditional approach
The vaccine uses more traditional technology than other US-approved vaccines, Levin said
The vaccine contains harmless parts of the coronavirus spike protein. In response to these parts, the body starts making antibodies that can neutralize the actual virus when a person becomes infected.
No serious side effects of the vaccine were seen in the adult studies, Levin said. Minor side effects included typical vaccine reactions such as injection site pain and fatigue.
However, there is always the potential for a rare but serious side effect. Johnson & Johnson’s use of the COVID-19 vaccine was temporarily suspended after several patients, including an 18-year-old Henderson woman who received the shot, were diagnosed with extremely rare but potentially life-threatening blood clots in the brain.
Although children are far less likely to get seriously ill with COVID-19 than adults than adults, Wesley Thurman said he was more concerned about possible side effects his son could experience from the disease than about possible side effects.
He also believes in vaccine trials to move the community forward.
“It is part of the support of the whole city to do business again and to help the schools to a normal flow in which the children can hopefully start the next school year personally and hopefully without mask requirements. ” he said.
In the United States, only the Pfizer BioNTech vaccine is currently approved for people under the age of 18. It is available to people aged 16 and over. The Food and Drug Administration is preparing to approve use for 12 to 15 year olds by early next week, the New York Times reported Monday.
For more information on the Novavax local clinical trial, call 702-893-8968.
Contact Mary Hynes at [email protected] or 702-383-0336. Follow @ MaryHynes1 on Twitter.