An early-stage clinical trial testing the safety and immune-stimulating ability of an experimental nasal influenza vaccine in healthy 9- to 17-year-old children and teens has begun enrolling participants at a Vaccine and Treatment Evaluation Unit (VTEU) site at Saint Louis University, St. Louis, Missouri. The VTEU is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
The investigational vaccine, developed by FluGen, Inc. of Madison, Wisconsin, is made from a strain of seasonal influenza virus (H3N2) that has been genetically designed to replicate only once in the body. Studies in animals showed that the “single replication” virus does not cause disease but nevertheless prompted a robust immune response akin to that of a natural influenza infection. Investigators hypothesize that volunteers who receive the candidate vaccine will have a robust immune response not only against H3N2 strains that match those in the vaccine but also against influenza strains that are mismatched to the vaccine strain. A previous Phase 1 trial of this candidate vaccine in healthy adults showed that it was safe and generated a robust immune response and a Phase 2 trial in healthy adults is currently underway (that trial is not supported by NIAID.)
Read more at NIAID.com.