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

Influenza H1N1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01019837
• Other study ID #: TASMC-09-ID-553-CTIL
• Status: Active, not recruiting
• Phase: N/A
• First received: November 22, 2009
• Last updated: November 23, 2009
• Start date: November 2009
• Est. completion date: April 2010

Study information

• Verified date: November 2009
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: April 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Influenza H1N1
• Influenza, Human

Intervention

Biological:
• Focetria (Monovalent MF59-Adjuvanted vaccine)
Biological: Focetria (Monovalent MF59-Adjuvanted vaccine)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Safety of the vaccine with regard to disease activity by changes in Crohn's Disease Activity Index (CDAI) and MAYO score		4 weeks	Yes