Hepatitis B Vaccine in Patients With Inflammatory Bowel Disease

Assessment of Hepatitis B Vaccination Efficacy in Patients With Inflammatory Bowel Diseases

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01531075

Acronym

HBV VIP

Enrollment

Registered

2012-02-10

Start date

2012-04-30

Completion date

2016-08-31

Last updated

2020-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Disease

Keywords

HBV, Inflammatory bowel disease, immunosuppressor

Brief summary

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

Interventions

BIOLOGICALENGERIX-B (HBV Vaccine)

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

BIOLOGICALSci-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026