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

Tel Aviv Sourasky Medical Center

Status: Unknown

Conditions: Influenza H1N1

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01019837

TASMC-09-ID-553-CTIL

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Monovalent MF59- Adjuvanted vaccine

Experimental group

Description:

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

Treatment:

Biological: Focetria (Monovalent MF59-Adjuvanted vaccine)