- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01531075
Hepatitis B Vaccine in Patients With Inflammatory Bowel Disease (HBV VIP)
Assessment of Hepatitis B Vaccination Efficacy in Patients With Inflammatory Bowel Diseases
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Beer- Sheva, Israel, 84101
- Soroka UMC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ENGERIX-B
|
ENGERIX-B (Hepatitis B Vaccine) 20 mcg, A series of 3 doses (1 mL each) given on a 0-, 1-, 6-month schedule.
Other Names:
|
Experimental: Sci-B-Vac
|
Sci-B-Vac (Hepatitis B Vaccine) 10 μg/ml, A series of 3 doses (1 mL each) given on a 0-, 1-, 6-month schedule.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
protective level of anti HBs antibodies
Time Frame: 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. |
1 month after the last does of vaccine
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ohad Etzion, MD, Soroka UMC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- sor026511ctil
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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