Hepatitis B Vaccine in Patients With Inflammatory Bowel Disease
Not Applicable
Completed
- Conditions
- Inflammatory Bowel Disease
- Registration Number
- NCT01531075
- Lead Sponsor
- Soroka University Medical Center
- Brief Summary
The objective is to assess the efficacy of Hepatitis B Virus vaccination in a population of IBD patients treated with immunosuppressive medications.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 91
Inclusion Criteria
- Male/female ≥ 18 years of age
- Evidence of IBD as diagnosed by clinical, laboratory imaging and endoscopic criteria.
- Treated with at least one immunosuppressive medication at the time of study initiation
- Provided written informed consent.
Exclusion Criteria
- Pregnant women
- Diagnosis of chronic viral hepatitis B
- Any major acute medical event in the 30 days prior to recruitment that necessitated hospitalization ( acute myocardial infarction, CVA, pulmonary emboli, sepsis, major trauma)
- Any other chronic inflammatory condition not related to IBD ( connective tissue disease, Chronic liver disease, COPD, poorly controlled diabetes mellitus)
- Active hematologic or oncologic diseases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method protective level of anti HBs antibodies 1 month after the last does of vaccine Antibody titer \>10 IU/ml 30 days following last vaccine dose will be considered protective.
In the work done by Altunoz et al., titer rate below 10 IU was observed in 40% of the patients, while 40% of the patients achieved a rate of above 100 IU. Therefore, we can estimate that the geometric mean of distribution is approx. 50 IU. A sample size of 37 patients in each group achieves a power of 80% to detect a ratio above 1.37 between the two vaccinated groups.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Soroka UMC
🇮🇱Beer- Sheva, Israel
Soroka UMC🇮🇱Beer- Sheva, Israel