Hepatitis B Vaccine in Patients With Inflammatory Bowel Disease

Soroka University Medical Center91 enrolled

Overview

The objective is to assess the efficacy of Hepatitis B Virus vaccination in a population of IBD patients treated with immunosuppressive medications.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Inflammatory Bowel Disease

Interventions

ENGERIX-B (HBV Vaccine)BIOLOGICAL

ENGERIX-B (Hepatitis B Vaccine) 20 mcg, A series of 3 doses (1 mL each) given on a 0-, 1-, 6-month schedule.

Sci-B-VacBIOLOGICAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Soroka UMC

Beersheba, Israel

Outcomes

Primary Outcomes

protective level of anti HBs antibodies

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.

Time frame: 1 month after the last does of vaccine

Data from ClinicalTrials.gov

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