Novartis swine flu vaccine shows good results in pilot trials
A pilot trial of Novartis adjuvanted cell culture-based A(H1N1) vaccine MF59 produced a strong immune response and was well tolerated, the drug company says.
A pilot trial of Novartis adjuvanted cell culture-based A(H1N1) vaccine MF59 produced a strong immune response and was well tolerated, the drug company says.
The trial, run by the UK's University of Leicester and University Hospitals of Leicester, tested the vaccine, on 100 healthy volunteers, aged between 18 and 50.
The trial evaluated the tolerability and immunogenicity of the vaccine which is to be called Celtura. Different schedules and timing between vaccinations were tested. 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.
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.
Larger pivotal trials with both cell culture and traditional egg based vaccines under way to include more than 6000 adults and children.