by Craig Boerner

Pediatricians with the Vanderbilt Vaccine Research Program are looking for healthy infants and children (6 months – 8 years of age) to take part in a nasal influenza vaccine study.

Influenza remains a common infection in children. Current flu vaccines are effective, but vaccines continue to be developed that are even more effective and may be given in ways other than injections, according to Stephanie Rolsma, MD, PhD, assistant professor of Pediatrics, Pediatric Infectious Diseases, and lead investigator for the study.

“I think kids often prefer anything but a shot,” Rolsma said. “Right now, the flu vaccine we get every year is a shot in the arm; this nasal spray vaccine would provide families with more choice for flu vaccine each year.”

The new live, attenuated vaccine made by FluGen is not yet FDA approved but has been evaluated in adults. The multi-site study also enrolled teenagers before slowly moving down into the younger ages.

“I don’t think any physician that you talk to would say that we currently have the best flu vaccine that we could make,” Rolsma said. “It is a problem every year because we have to guess what strains will be coming up so there is variable efficacy. Even in years with a good match it is not quite as effective as, say, a measles vaccine.”

Study participants will first receive the nasal spray influenza vaccine being studied and, later on in the study, they will receive the normal flu vaccine, which is an injection in the arm.

“Since we don’t know if the vaccine we are studying is as effective as the standard injected flu vaccine, we will give everyone a regular flu shot as well, to protect them against influenza,” Rolsma said.

“We think this vaccine will induce mucosal immune responses at the lining of the nose, so we are hopeful that it will prove to be more effective. It is a live, attenuated vaccine but it doesn’t replicate in cells, which is important because we think that will be safer and minimize side effects.”

Typical side effects for a nasal spray vaccine include sneezing or discomfort in the nose, nasal drainage, and possibly mild malaise or low-grade fever afterward.

Investigators will be paying special attention to see if wheezing is a side effect, Rolsma said, because that has been a concern with other intranasal flu vaccines, such as FluMist.

FluMist, also a nasal spray flu vaccine, is licensed, but in the past has not been recommended because of concerns about its effectiveness.

Additionally, this vaccine is not available for children under 2 years of age or for those who are close contacts of immunocompromised people.

This study involves either one or two doses of vaccine, plus the normal seasonal influenza vaccine, along with three blood samples spread out over one year. Participants will be compensated up to $570 for their time and travel.

For more information about the study, or to see if you qualify, email vaccineresearch@vumc.org or call (615) 343-2877.