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Inflammatory Bowel DiseasePhase 4NCT01341808

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

A Phase 4 study testing Epaxal Berna (virosomal hepatitis A vaccine) in people with Inflammatory Bowel Disease and Crohn's Disease, run by Asan Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 40 years
What is being tested?
Epaxal Berna (virosomal hepatitis A vaccine)
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
493 participants
Where
1 siteSouth Korea
Study dates
Apr 2011to Mar 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients suffering from inflammatory bowel disease: Crohn's disease/Ulcerative colitis
  • Age 18-40
  • Willing to provide informed consent

Who cannot join

  • Have history of vaccination to hepatitis A
  • Have other autoimmune disease
  • Have any malignancy
  • Have acute infectious disease
  • Unwilling to provide consent

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

About this study

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

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.

Being tested
Epaxal Berna (virosomal hepatitis A vaccine)
Keywords
Crohn's disease, Ulcerative colitis, Hepatitis A, vaccine
Medical subject headings
Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative, Hepatitis A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Epaxal Berna (virosomal hepatitis A vaccine)Biological

    Also called Epaxal Berna

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

Study groups in NCT01341808
Study groupRoleWhat they receive
IBD patientsExperimentalPatients diagnosed with IBD -> receive Epaxal Berna (virosomal hepatitis A vaccine)
Receives: Biological: Epaxal Berna (virosomal hepatitis A vaccine)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. antibody titer to hepatitis A vaccine

    Measured: Month 7

Secondary outcomes (2)

  1. vaccine-associated adverse events and side effects

    Measured: within the first 30 days after first vaccination

  2. vaccine-associated adverse events and side effects

    Measured: within the first 30 days after second vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionFeb 2013
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
493 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01341808
Sponsor's protocol ID
2011-0047
Status last verified
Mar 2013
First submitted
25 Apr 2011
Last updated
19 Mar 2013
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Epaxal Berna (virosomal hepatitis A vaccine) in people with Inflammatory Bowel Disease and Crohn's Disease, run by Asan Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

antibody titer to hepatitis A vaccine (time frame: Month 7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01341808, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2013.

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