NCT01341808

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
493

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 26, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 19, 2013

Status Verified

March 1, 2013

Enrollment Period

1.8 years

First QC Date

April 25, 2011

Last Update Submit

March 16, 2013

Conditions

Inflammatory Bowel DiseaseCrohn's DiseaseUlcerative ColitisHepatitis A

Keywords

Crohn's diseaseUlcerative colitisHepatitis Avaccine

Outcome Measures

Primary Outcomes (1)

  • antibody titer to hepatitis A vaccine

    Month 7

Secondary Outcomes (2)

  • vaccine-associated adverse events and side effects

    within the first 30 days after first vaccination

  • vaccine-associated adverse events and side effects

    within the first 30 days after second vaccination

Study Arms (1)

IBD patients

EXPERIMENTAL

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

Biological: Epaxal Berna (virosomal hepatitis A vaccine)

Interventions

Epaxal Berna (virosomal hepatitis A vaccine)BIOLOGICAL

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

Also known as: Epaxal Berna
IBD patients

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

Related Publications (3)

  • 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.

    PMID: 16553593BACKGROUND

  • 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.

    PMID: 20480515BACKGROUND

  • 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.

    PMID: 24284413DERIVED

MeSH Terms

Conditions

Inflammatory Bowel DiseasesCrohn DiseaseColitis, UlcerativeHepatitis A

Interventions

epaxal berna

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic DiseasesHepatitis, Viral, HumanVirus DiseasesInfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsHepatitisLiver Diseases

Study Officials

  • Suk-Kyun Yang, M.D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 25, 2011

First Posted

April 26, 2011

Study Start

April 1, 2011

Primary Completion

February 1, 2013

Study Completion

March 1, 2013

Last Updated

March 19, 2013

Record last verified: 2013-03

Locations

KR(1)