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Pilot A(H1N1) Trial Suggests One Dose Can Induce Protective Antibodies LEICESTER, United Kingdom -- September 4, 2009 -- Results from the first influenza A(H1N1) vaccine trials taking place in Leicester, United Kingdom reveal a strong immune response after just 1 dose. The pilot study, run by the University of Leicester and Leicester Hospitals, includes 100 healthy volunteers, aged 18 to 50 years. Lead investigator Iain Stephenson, MD, Department of Infection, Immunity and Inflammation, Leicester Royal Infirmary, said: “The clinical trial of Novartis MF59-adjuvanted cell-based A(H1N1) vaccine indicates that the vaccine elicits a strong immune response and is well-tolerated. “Results showed that the serum antibody responses were highest individuals subjects who received 2 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 antibody against A(H1N1) infection within 2 weeks of administration of a single low-dose adjuvanted vaccine.” Non-adjuvanted formulations were not evaluated in this part of the study and will be evaluated shortly. The trial evaluated the tolerability and immunogenicity of the vaccine, and tested different schedules of vaccination, in terms of time between vaccinations. The vaccine schedule was 1 or 2 doses of 7.5 mcg MF-59 adjuvanted surface-antigen A/California/2009 vaccine derived from cell-culture. “The aim of the trial was to find out how many doses and what type of vaccine is needed to give protection,” said Dr. Stephenson. “These initial results should help to plan vaccination campaigns in the autumn, including doses and timings.” “We concluded that the MF59-adjuvanted A(H1N1) vaccine of low antigen content was well tolerated and generated antibody responses associated with protection against influenza, even after a single dose.” “The results suggest that 1 vaccine dose may be sufficient to protect against the A(H1N1) virus rather than 2,” he said. “Larger trials are already underway around the world. Timings on when the vaccine will be available to governments will depend on the results of these clinical trials, and approvals by regulatory authorities’’ The research found the vaccine is well tolerated with pain at the injection site the most frequent adverse event. SOURCE: University of Leicester E-mail this page to a friend or colleague! To print, use this version