Efficacy and Safety of Vaccination Against Influenza H1N1 in Patients With Inflammatory Bowel Diseases (IBD) Treated Immunomodulators and Biologics

Not Applicable

• Conditions: Influenza H1N1
• Interventions: Biological: Focetria (Monovalent MF59-Adjuvanted vaccine)

• Registration Number: NCT01019837
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

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.

Detailed 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

Study Timeline

• Status Verified: 2009-11
• Study Start: 2009-11
• Primary Completion: 2009-11
• Study First Submitted: 2009-11-22
• Study First Submitted QC: 2009-11-23
• Last Update Submitted: 2009-11-23
• Study First Posted: 2009-11-25
• Last Update Posted: 2009-11-25
• Study Completion: 2010-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Monovalent MF59- Adjuvanted vaccine	Focetria (Monovalent MF59-Adjuvanted vaccine)	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

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Safety of the vaccine with regard to disease activity by changes in Crohn's Disease Activity Index (CDAI) and MAYO score	4 weeks