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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Suk-Kyun Yang, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01341808
First received: April 25, 2011
Last updated: March 16, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis
Hepatitis A
Biological: Epaxal Berna (virosomal hepatitis A vaccine)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity of Hepatitis A Vaccine in Patients With Inflammatory Bowel Disease

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • antibody titer to hepatitis A vaccine [ Time Frame: Month 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • vaccine-associated adverse events and side effects [ Time Frame: within the first 30 days after first vaccination ] [ Designated as safety issue: Yes ]
  • vaccine-associated adverse events and side effects [ Time Frame: within the first 30 days after second vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 493
Study Start Date: April 2011
Study Completion Date: March 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IBD patients

Patients diagnosed with IBD

-> receive Epaxal Berna (virosomal hepatitis A vaccine)

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

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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01341808

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Suk-Kyun Yang, M.D. Asan Medical Center
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Suk-Kyun Yang, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01341808     History of Changes
Other Study ID Numbers: 2011-0047
Study First Received: April 25, 2011
Last Updated: March 16, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:
Crohn's disease
Ulcerative colitis
Hepatitis A
vaccine

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Crohn Disease
Colitis
Ulcer
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Gastroenteritis
Gastrointestinal Diseases
Colonic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 02, 2014