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

Information source: Asan Medical Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis; Hepatitis A

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

Phase: Phase 4

Status: Completed

Sponsored by: Asan Medical Center

Official(s) and/or principal investigator(s):
Suk-Kyun Yang, M.D., Principal Investigator, Affiliation: Asan Medical Center


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

Clinical Details

Official title: Immunogenicity of Hepatitis A Vaccine in Patients With Inflammatory Bowel Disease

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: antibody titer to hepatitis A vaccine

Secondary outcome:

vaccine-associated adverse events and side effects

vaccine-associated adverse events and side effects

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.


Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Both.


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 and Contacts

Asan Medical Center, Seoul 138-736, Korea, Republic of
Additional Information

Related publications:

D'Acremont V, Herzog C, Genton B. Immunogenicity and safety of a virosomal hepatitis A vaccine (Epaxal) in the elderly. J Travel Med. 2006 Mar-Apr;13(2):78-83.

Hou JK, Velayos F, Terrault N, Mahadevan U. Viral hepatitis and inflammatory bowel disease. Inflamm Bowel Dis. 2010 Jun;16(6):925-32. doi: 10.1002/ibd.21284. Review.

Starting date: April 2011
Last updated: March 16, 2013

Page last updated: August 20, 2015

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