Crohn's Disease, Hepatitis A, Inflammatory Bowel Disease, Ulcerative Colitis
Conditions
Keywords
Crohn's disease, Ulcerative colitis, Hepatitis A, vaccine
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.
Interventions
BIOLOGICALEpaxal Berna (virosomal hepatitis A vaccine)
standard 0.5 mL dose of Epaxal Berna (virosomal hepatitis A vaccine) given at Day 0, Month 6.
Sponsors
Asan Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| antibody titer to hepatitis A vaccine | Month 7 |
Secondary
| Measure | Time frame |
|---|---|
| vaccine-associated adverse events and side effects | within the first 30 days after first vaccination |
Countries
South Korea
Outcome results
None listed