The spread of Influenza H1N1 has prompted the development of vaccines against this virus. IBD patients are at increased risk of developing complications of Influenza H1N1. The efficacy and safety of H1N1 vaccination have not been evaluated in this population of patients. We would like to estimate the efficacy and safety of vaccination against influenza H1N1 in patients with IBD who treated with immunomodulatory drugs.
200 patients with IBD and 200 healthy subjects will participate in the study. All the subjects will be vaccinated with Focetria (Novartis) and will be evaluated the day of vaccination and 4 weeks later. The evaluation will include: Efficacy of the vaccine: Blood will be drawn on day 0 and 4 weeks later and tested for the presence of antibodies against A/California17/2009/H1N1 by hemagglutination inhibition test. Safety of the vaccine: * Records of adverse event * Assessment of disease activity : CDAI and MAYO score
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
200
Biological: Focetria (Monovalent MF59-Adjuvanted vaccine)
Proportion of patients who will achieve a titer of antibodies above 1/40 within the groups of patients in comparison with healthy subjects
Time frame: 4 weeks
Safety of the vaccine with regard to disease activity by changes in Crohn's Disease Activity Index (CDAI) and MAYO score
Time frame: 4 weeks
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