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

Phase 4

Completed

• Conditions: Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis; Hepatitis A
• Interventions: Biological: Epaxal Berna (virosomal hepatitis A vaccine)

• Registration Number: NCT01341808
• Lead Sponsor: Asan Medical Center

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-25
• Study First Submitted QC: 2011-04-25
• Study First Posted: 2011-04-26
• Primary Completion: 2013-02
• Status Verified: 2013-03
• Study Completion: 2013-03
• Last Update Submitted: 2013-03-16
• Last Update Posted: 2013-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 493

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IBD patients	Epaxal Berna (virosomal hepatitis A vaccine)	Patients diagnosed with IBD -\> receive Epaxal Berna (virosomal hepatitis A vaccine)

Primary Outcome Measures

Name	Time	Method
antibody titer to hepatitis A vaccine	Month 7

Secondary Outcome Measures

Name	Time	Method
vaccine-associated adverse events and side effects	within the first 30 days after second vaccination

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of