NCT01341808

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

Immunogenicity of Hepatitis A Vaccine in Patients With Inflammatory Bowel Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 493 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-04-01
• Primary completion: 2013-02-01
• Completion: 2013-03-01
• First posted: 2011-04-26
• Last updated: 2013-03-19

Locations

1 site across 1 country: South Korea