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

Asan Medical Center

Status and phase: Completed; Phase 4

Conditions: Hepatitis A; Inflammatory Bowel Disease; Ulcerative Colitis; Crohn's Disease

Treatments: Biological: Epaxal Berna (virosomal hepatitis A vaccine)

Study type: Interventional

Funder types: Other

Identifiers

NCT01341808

2011-0047

Details and patient eligibility

About

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

Full 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.

Enrollment: 493 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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493 participants in 1 patient group

IBD patients

Experimental group

Description:

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

Treatment:

Biological: Epaxal Berna (virosomal hepatitis A vaccine)