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
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.
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 effectsvaccine-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.
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Both.
Criteria:
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
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