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Nashville children's hospital needs 200 volunteers for pediatric nasal flu vaccine trial

Posted at 4:00 AM, Aug 25, 2022
and last updated 2022-08-25 18:12:22-04

NASHVILLE, Tenn. (WTVF) — Monroe Carell Jr. Children's Hospital at Vanderbilt needs 200 pediatric volunteers for a nasal flu vaccine trial that researchers said should be more effective than the traditional flu shot.

The trial began with adults in the past few years and moved to children. During the fall of 2022, the clinical trial needs kids ages 2 to 8 years old for the upcoming testing group.

"We'll go down a step further in the six months to two years of age a little bit later," said Dr. Stephanie Rolsma, Vanderbilt Infectious Diseases assistant professor.

The pharmaceutical company seeking the research is FluGen, which was established in 2007. Participants will be given around $500 for their time and travel, which is funded by the clinical trial's sponsor: The National Institutes of Health.

The trial is available across the country but requires in-person visits. The total number of visits varies from three to five based on which group the participant is enrolled in. However, regardless of the number of clinic visits, there will only be three blood draws and three nasal washes obtained per child.

"We do the vaccine and a blood draw and nasal wash sample which is kind of putting liquid in the nose then collecting the liquid right away to look for immune responses there," Rolsma said. "So that's all on the first day. So that's a big day. And then we watch people really carefully, so we have them fill out a diary of symptoms. We call families to check up to see if there's any symptoms or side effects, and then we bring them back on a variable schedule depending on which exact group that they're enrolled in. We follow subjects for about a year."

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Vanderbilt Infectious Diseases Assistant Professor Dr. Stephanie Rolsma

Although this is not the only nasal spray that has been tested for the flu, Rolsma said this vaccine should affect patients differently.

"You might have heard of another nasal spray like the flu mist, which is a different live attenuated influenza vaccine," she said. "That one's a little bit more limited. So you have to be at least 2 years old to get that, and then through kind of middle age, that's a live attenuated vaccine that actually replicates and so people who get that vaccine can potentially shed the virus so we have to be really careful about not giving it to people, you know, who live with other people who are immunocompromised. This vaccine is a little bit different. It doesn't replicate at all. So people won't shed the vaccine after they get immunized."

Rolsma said she and her research team are hopeful the trial will open the door to a more effective vaccine.

"We're really excited about this vaccine because I think there's room for improvement with our current flu vaccines, and we're hopeful that this vaccine is actually going to be more effective," she said. "Vaccines are always difficult to develop. But influence I think, has been a particular challenge, which is why we're looking for new strategies."

To learn more about the vaccine trial or sign up, contact Dr. Buddy Creech and his team at 615-343-2877 or email them vaccineresarch@vumc.org.

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Dr. Stephanie Rolsma predicted the nasal spray vaccine to be more effective than the traditional injection flu shot.