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

Primary Purpose

Inflammatory Bowel Disease

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
ENGERIX-B (HBV Vaccine)
Sci-B-Vac
Sponsored by
Soroka University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inflammatory Bowel Disease focused on measuring HBV, Inflammatory bowel disease, immunosuppressor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Soroka UMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ENGERIX-B

Sci-B-Vac

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 8, 2012
Last Updated
April 19, 2020
Sponsor
Soroka University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01531075
Brief Title
Hepatitis B Vaccine in Patients With Inflammatory Bowel Disease
Acronym
HBV VIP
Official Title
Assessment of Hepatitis B Vaccination Efficacy in Patients With Inflammatory Bowel Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 2012 (Actual)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soroka University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease
Keywords
HBV, Inflammatory bowel disease, immunosuppressor

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ENGERIX-B
Arm Type
Experimental
Arm Title
Sci-B-Vac
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
ENGERIX-B (HBV Vaccine)
Other Intervention Name(s)
ENGERIX-B
Intervention Description
ENGERIX-B (Hepatitis B Vaccine) 20 mcg, A series of 3 doses (1 mL each) given on a 0-, 1-, 6-month schedule.
Intervention Type
Biological
Intervention Name(s)
Sci-B-Vac
Intervention Description
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.
Primary Outcome Measure Information:
Title
protective level of anti HBs antibodies
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ohad Etzion, MD
Organizational Affiliation
Soroka UMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soroka UMC
City
Beer- Sheva
ZIP/Postal Code
84101
Country
Israel

12. IPD Sharing Statement

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Hepatitis B Vaccine in Patients With Inflammatory Bowel Disease

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