Immunogenicity of Hepatitis A Vaccine in Inflammatory Bowel Disease (IBD) Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

493 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-03-31

Brief Summary

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The purpose of this study is to measure the immune response in 18-40 year old IBD patients after receiving the hepatitis A vaccine.

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Detailed Description

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The spread of hepatitis A has prompted the need for vaccination against this virus. It is uncertain that IBD patients can achieve a truly protective response after vaccination. The efficacy and safety of hepatitis A vaccination have not been evaluated in this population of patients. We would like to estimate the efficacy and safety of vaccination against hepatitis A in patients with IBD.

Conditions

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Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis Hepatitis A

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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IBD patients

Patients diagnosed with IBD

-\> receive Epaxal Berna (virosomal hepatitis A vaccine)

Group Type EXPERIMENTAL

Epaxal Berna (virosomal hepatitis A vaccine)

Intervention Type BIOLOGICAL

standard 0.5 mL dose of Epaxal Berna (virosomal hepatitis A vaccine) given at Day 0, Month 6.

Interventions

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Epaxal Berna (virosomal hepatitis A vaccine)

standard 0.5 mL dose of Epaxal Berna (virosomal hepatitis A vaccine) given at Day 0, Month 6.

Intervention Type BIOLOGICAL

Other Intervention Names

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Epaxal Berna

Eligibility Criteria

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Inclusion Criteria

1. Patients suffering from inflammatory bowel disease: Crohn's disease/Ulcerative colitis
2. Age 18-40
3. Willing to provide informed consent

Exclusion Criteria

1. Have history of vaccination to hepatitis A
2. Have other autoimmune disease
3. Have any malignancy
4. Have acute infectious disease
5. Unwilling to provide consent

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No