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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monovalent MF59- Adjuvanted vaccine | Experimental | Focetria (Monovalent MF59-Adjuvanted vaccine) 7.5 mcg Hemagglutinin H1/InfluezaA/California/7/2009 ,9.75 mg squalene MF59, 1.175 mg polysort80, 1.175 mg sorbitan trioleate Intra muscular |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Focetria (Monovalent MF59-Adjuvanted vaccine) | Biological | Biological: Focetria (Monovalent MF59-Adjuvanted vaccine) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who will achieve a titer of antibodies above 1/40 within the groups of patients in comparison with healthy subjects | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the vaccine with regard to disease activity by changes in Crohn's Disease Activity Index (CDAI) and MAYO score | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Iris Dotan, Dr. | Tel-Aviv Sourasky Medical Center | Study Director |
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| ID | Term |
|---|---|
| C558220 | focetria |
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