Novartis MF59 adjuvanted cell culture-based vaccine shows strong immune response in A(H1N1) clinical trials
Larger pivotal trials with both cell culture and traditional egg based vaccines under way to include more than 6000 adults and children
A pilot trial of Novartis adjuvanted cell culture-based A(H1N1) vaccine indicates that the "swine flu" vaccine elicited a strong immune response and was well tolerated. The trial was run by the UK's University of Leicester and University Hospitals of Leicester. The vaccine, to be called Celtura®, was tested with 100 healthy volunteers, aged between 18 and 50.
The trial evaluated the tolerability and immunogenicity of the vaccine. 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. Hemagglutination-inhibition titres reached 1:40 or greater in 80 percent and more than 90 percent 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 pivotal clinical trials, with larger numbers of subjects and sponsored by Novartis, are already under way around the world. They will include more than 6000 adults and children.
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Topic world Antibodies
Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous
