Sept. 18 (UPI) -- Testing has begun for an experimental nasal flu vaccine in healthy children 9 to 17 years old.
The Phase 1 clinical trial, which is being conducted at a Vaccine and Treatment Evaluation Unit site in St. Louis, is funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. It is scheduled to be completed next July, according to the agency
Because the influenza virus changes from year to year, vaccines must be reformulated annually.
"We are hopeful that newer kinds of influenza vaccines, such as the candidate being tested in this trial, will provide protection even if their components do not precisely match the currently circulating influenza virus strains," Dr. Anthony S. Fauci, the NIAID director, said in a press release.
Annual vaccination against the flu is recommended for everyone older than 6 months of age. The Centers for Disease Control and Prevention doesn't recommend nasal sprays for children younger than 2. Vaccines also are administered via injections.
Half of the 50 participants in the trial will receive the experimental nasal vaccine, and the other half will receive a dose of inactive saline solution delivered as nasal spray.
Three months after receiving their dosage, all volunteers will receive an intramuscular injection of a licensed, quadrivalent seasonal influenza vaccine.
Researchers want to determine whether the combination leads to broader protection against influenza viruses compared with the licensed vaccine alone.
Blood samples will be taken at four points throughout the trial to detect immune reaction from antibody-producing cells and the immune system.
FluGen, Inc. of Madison, Wis., developed the vaccine from a strain of seasonal influenza virus, H3N2, that has been genetically designed to replicate only once in the body.
In animal studies, this "single replication" virus was found to not cause disease but instead produce a robust immune response similar to that of a natural influenza infection.
Researchers believe the candidate vaccine will produce a strong immune response not only against H3N2 strains but also against influenza strains that are mismatched to the vaccine strain.
In a Phase 1 trial of this vaccine in healthy adults, it safely generated a robust immune response. A Phase 2 trial in healthy adults is currently underway but not supported by NIAID.
FluGen was founded in 2007 "in response to the need for better methods of preventing influenza infections," the company wrote on its website. Staffers are associated with the University of Wisconsin.