search
Back to results

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

Primary Purpose

Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Epaxal Berna (virosomal hepatitis A vaccine)
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inflammatory Bowel Disease focused on measuring Crohn's disease, Ulcerative colitis, Hepatitis A, vaccine

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IBD patients

Arm Description

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

Outcomes

Primary Outcome Measures

antibody titer to hepatitis A vaccine

Secondary Outcome Measures

vaccine-associated adverse events and side effects
vaccine-associated adverse events and side effects

Full Information

First Posted
April 25, 2011
Last Updated
March 16, 2013
Sponsor
Asan Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01341808
Brief Title
Immunogenicity of Hepatitis A Vaccine in Inflammatory Bowel Disease (IBD) Patients
Official Title
Immunogenicity of Hepatitis A Vaccine in Patients With Inflammatory Bowel Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis, Hepatitis A
Keywords
Crohn's disease, Ulcerative colitis, Hepatitis A, vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
493 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IBD patients
Arm Type
Experimental
Arm Description
Patients diagnosed with IBD -> receive Epaxal Berna (virosomal hepatitis A vaccine)
Intervention Type
Biological
Intervention Name(s)
Epaxal Berna (virosomal hepatitis A vaccine)
Other Intervention Name(s)
Epaxal Berna
Intervention Description
standard 0.5 mL dose of Epaxal Berna (virosomal hepatitis A vaccine) given at Day 0, Month 6.
Primary Outcome Measure Information:
Title
antibody titer to hepatitis A vaccine
Time Frame
Month 7
Secondary Outcome Measure Information:
Title
vaccine-associated adverse events and side effects
Time Frame
within the first 30 days after first vaccination
Title
vaccine-associated adverse events and side effects
Time Frame
within the first 30 days after second vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients suffering from inflammatory bowel disease: Crohn's disease/Ulcerative colitis Age 18-40 Willing to provide informed consent Exclusion Criteria: Have history of vaccination to hepatitis A Have other autoimmune disease Have any malignancy Have acute infectious disease Unwilling to provide consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suk-Kyun Yang, M.D.
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
16553593
Citation
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.
Results Reference
background
PubMed Identifier
20480515
Citation
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.
Results Reference
background
PubMed Identifier
24284413
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs