Novartis says swine flu vaccine is well tolerated

Swiss drugmaker Novartis says the pilot trial of its adjuvanted cell culture-based swine flu vaccine elicited a "strong immune response and was well tolerated".

The UK's University of Leicester and University Hospitals of Leicester conducted the trial. The vaccine, to be called Celtura, was tested with 100 healthy volunteers, aged between 18 and 50.

The vaccine schedule comprised one or two doses of 7.5µg MF-59 adjuvanted surface-antigen A/California/2009 vaccine derived from cell-culture. Results showed that the serum antibody responses were highest among subjects who received two doses of vaccine, however a single vaccine dose also induced responses associated with protection against influenza. Haemagglutination-inhibition titres reached 1:40 or greater in 80% and more than 90% of those receiving one dose and two doses respectively. These would satisfy the immunogenicity criteria as set out by European and US regulators. The findings showed that it is possible to induce protective antibodies against A(H1N1) infection within two weeks of administration of a single low-dose adjuvanted vaccine. Non-adjuvanted formulations were not evaluated in the study.

Additional clinical trials, with more than 6,000 adults and children, are already under way around the world.

"The pilot trial results are encouraging," said Dr Andrin Oswald, chief executive of Novartis vaccines and diagnostics. "The study suggests that while two doses seem to provide better protection, one dose of our adjuvanted Celtura vaccine may be sufficient to protect adults against the swine flu."