Researchers at St. Louis University reported that an early-stage trial testing an experimental nasal flu vaccine in children and teens began enrolling participants this week.
In the 50-person study, half of the participants will receive the investigational nasal vaccine and the other half will receive an inactive saline solution. All of the study’s participants are slated to receive an intramuscular injection of a quadrivalent seasonal flu vaccine three months following the initial dose of nasal vaccine or placebo.
Researchers are trying to understand if the combination of the quadrivalent seasonal flu vaccine and the investigational nasal vaccine will lead to broader protection against flu viruses compared to the quadrivalent vaccine alone. Researchers plan to assess the participants’ blood samples four times following the initial vaccination and three weeks after the second vaccination.
The Phase I trial is being conducted at a Vaccine and Treatment Evaluation Unit site at the university, funded by the NIH’s National Institute of Allergy and Infectious Diseases.
The experimental nasal vaccine, made by FluGen, was developed from a strain of seasonal flu virus that has been genetically modified to replicate just once in the body, according to the NIH. This feature stops the virus from causing disease, but triggers the body into producing an immune response. Researchers predict that volunteers who receive the experimental vaccine will be protected against an array of flu viruses.
“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,” NIAID director Dr. Anthony Fauci said in prepared remarks.
A Phase II trial of the vaccine in healthy adults is also underway.