NEW YORK (Reuters Health) – A “prepandemic” avian influenza A (H5N1) vaccine proved safe and immunogenic in a preliminary clinical trial with children, mirroring the results of a recent trial conducted in adults, Hungarian researchers report in the Pediatric Infectious Disease Journal for December.
Fluval, a “monovalent, hens’-egg-grown, formaldehyde-inactivated, whole virus, aluminum phosphate adjuvanted vaccine, developed and produced by Omninvest LTD (Hungary) was used,” write Dr. Zoltan Vajo, at the National Center for Immunology and Allergy in Budapest, and co-authors.
Twelve healthy children, 9 to 17 years of age, received a single dose of 6 µg Fluval by intramuscular injection. No side effects were detected.
On day 21, the rate of seroprotection was 75%, with a 75% rate of seroconversion in the hemagglutination titer. Similar results using the same vaccine were reported last year following a clinical trial involving 146 adults.
“The vaccine fulfilled all applicable U.S. and European immunogenicity criteria for licensure,” the authors maintain.
Dr. Vajo’s team points out that other H5N1 vaccines approved by regulatory agencies require higher total doses, with at least two injections administered 21-28 days apart.
Pediatr Infect Dis J 2008;27:1052-1056.