Hepatitis B Vaccine in Patients With Inflammatory Bowel Disease

Not Applicable

Completed

• Conditions: Inflammatory Bowel Disease
• Interventions: Biological: Sci-B-Vac; Biological: ENGERIX-B (HBV Vaccine)

• 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

Study Timeline

• Study First Submitted: 2012-02-08
• Study First Submitted QC: 2012-02-09
• Study First Posted: 2012-02-10
• Study Start: 2012-04
• Primary Completion: 2015-08
• Study Completion: 2016-08
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-19
• Last Update Posted: 2020-04-21

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

Arm && Interventions

Group	Intervention	Description
Sci-B-Vac	Sci-B-Vac	-
ENGERIX-B	ENGERIX-B (HBV Vaccine)	-

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.

Trial Locations

Locations (1)

Soroka UMC; 🇮🇱 Beer- Sheva, Israel