Hepatitis B Vaccine in Patients With Inflammatory Bowel Disease (HBV VIP)

Soroka University Medical Center

Status: Completed

Conditions: Inflammatory Bowel Disease

Treatments: Biological: ENGERIX-B (HBV Vaccine); Biological: Sci-B-Vac

Study type: Interventional

Funder types: Other

Identifiers

NCT01531075

sor026511ctil

Details and patient eligibility

About

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

Enrollment: 91 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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91 participants in 2 patient groups

ENGERIX-B

Experimental group

Treatment:

Biological: ENGERIX-B (HBV Vaccine)

Sci-B-Vac

Experimental group

Treatment:

Biological: Sci-B-Vac