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CompletedNCT01341808Updated Mar 19, 2013

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

A Phase 4 interventional study of Epaxal Berna (virosomal hepatitis A vaccine) in Inflammatory Bowel Disease, Crohn's Disease and Ulcerative Colitis, sponsored by Asan Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2013-03-19.

Sponsored by Asan Medical Center · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
493
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Inflammatory Bowel Disease
  • Crohn's Disease
  • Ulcerative Colitis
  • Hepatitis A

Keywords

  • Crohn's disease
  • Ulcerative colitis
  • Hepatitis A
  • vaccine
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In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 493 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Asan Medical Center is the lead sponsor of 562 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
493 participants (actual)

Study arms

  • Experimental
    IBD patients

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

    Biological: Epaxal Berna (virosomal hepatitis A vaccine)

Interventions

  • BiologicalEpaxal Berna (virosomal hepatitis A vaccine)

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

    Also known as: Epaxal Berna

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What researchers measure

Primary outcomes

  1. antibody titer to hepatitis A vaccine

    Time frame: Month 7

Secondary outcomes

  1. vaccine-associated adverse events and side effects

    Time frame: within the first 30 days after first vaccination

  2. vaccine-associated adverse events and side effects

    Time frame: within the first 30 days after second vaccination

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Study locations

1 site
  • Asan Medical Center
    Seoul, 138-736, Korea, Republic of
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References and documents

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. doi: 10.1111/j.1708-8305.2006.00001.x. PubMed 16553593 ↗
  • 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. PubMed 20480515 ↗
  • Park SH, Yang SK, Park SK, Kim JW, Yang DH, Jung KW, Kim KJ, Ye BD, Byeon JS, Myung SJ, Kim JH. Efficacy of hepatitis A vaccination and factors impacting on seroconversion in patients with inflammatory bowel disease. Inflamm Bowel Dis. 2014 Jan;20(1):69-74. doi: 10.1097/01.MIB.0000437736.91712.a1. PubMed 24284413 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01341808
Lead sponsor
Asan Medical Center
Responsible party
Suk-Kyun Yang (Professor, Asan Medical Center) — Principal investigator
First posted
Apr 26, 2011
Start date
Apr 2011
Primary completion
Feb 2013
Completion
Mar 2013
Last update
Mar 19, 2013

Study contacts

Suk-Kyun Yang, M.D.
principal investigator · Asan Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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