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Completed

NCT Number: NCT01341808

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

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

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Key information

Conditions

Inflammatory Bowel Disease Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Crohn's Disease Digestive System Diseases Enterovirus Infections Gastroenteritis Gastrointestinal Diseases Hepatitis Hepatitis A Hepatitis, Viral, Human Infections Inflammatory Bowel Diseases Intestinal Diseases Liver Diseases Picornaviridae Infections RNA Virus Infections Ulcerative Colitis Virus Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asan Medical Center

Seoul, 138-736, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Epaxal Berna

Primary outcomes

  1. antibody titer to hepatitis A vaccine

    Time frame: Month 7

Secondary outcomes

  1. vaccine-associated adverse events and side effects

    Time frame: within the first 30 days after first vaccination

  2. vaccine-associated adverse events and side effects

    Time frame: within the first 30 days after second vaccination

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

Immunogenicity of Hepatitis A Vaccine in Patients With Inflammatory Bowel Disease

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 26, 2011
Registry last updated
Mar 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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