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

Asan Medical Center493 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

493

Conditions

Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis Hepatitis A

Interventions

Epaxal Berna (virosomal hepatitis A vaccine)BIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Asan Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

antibody titer to hepatitis A vaccine

Time frame: Month 7

Secondary Outcomes

vaccine-associated adverse events and side effects

Time frame: within the first 30 days after first vaccination

vaccine-associated adverse events and side effects

Time frame: within the first 30 days after second vaccination

Data from ClinicalTrials.gov

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