Efficacy and Safety of Vaccination Against Influenza H1N1 in Patients With Inflammatory Bowel Diseases (IBD) Treated Immunomodulators and Biologics
This trial is active, not recruiting.
|Treatment||focetria (monovalent mf59-adjuvanted vaccine)|
|Sponsor||Tel-Aviv Sourasky Medical Center|
|Start date||November 2009|
|End date||November 2009|
|Trial size||200 participants|
|Trial identifier||NCT01019837, TASMC-09-ID-553-CTIL|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
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
Male or female participants from 18 years up to 65 years old.
Inclusion Criteria: 1. Patients suffering from IBD (inflammatory bowel disease): UC/ CD 2. Able to firm an informed consent 3. Aged - 18-65 4. Candidates to receive vaccination against H1N1, according to the recommendation of the Ministry of Health 5. patients who treated with immunomodulators and biologics Exclusion Criteria: 1. Allergy to eggs 2. Known allergy to seasonal influenza vaccine 3. Pregnant women 4. Patients who inoculate another vaccine in the past 3 weeks (except vaccine fot seasonal influenza 5. Patients without worsening in their disease condition (stable condition)
|Official title||Efficacy and Safety of Vaccination Against Influenza H1N1 in Patients With Inflammatory Bowel Diseases Treated With Immunomodulators and Biologics|
|Description||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|
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