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

This study is currently recruiting participants.

Verified June 2012 by Soroka University Medical Center

Sponsor:

Information provided by (Responsible Party):

Ohad Etzion, Soroka University Medical Center

ClinicalTrials.gov Identifier:

NCT01531075

First received: February 8, 2012

Last updated: June 6, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 8, 2012

Last Updated Date

June 6, 2012

Start Date ^ICMJE

May 2012

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

protective level of anti HBs antibodies [ Time Frame: 1 month after the last does of vaccine ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

Protective level of anti HBs antibody titer [ Time Frame: 1 month after the last does of vaccine ] [ Designated as safety issue: No ]

The purpose of this study will be to assess the rate of development of protective anti HBs antibodies following standard 3 dose schedule HBV vaccination (binary outcome). Antibody titer >10 IU/ml 30 days following last vaccine dose will be considered protective.

Change History

Complete list of historical versions of study NCT01531075 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Hepatitis B Vaccine in Patients With Inflammatory Bowel Disease

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Inflammatory Bowel Disease

Intervention ^ICMJE

Biological: ENGERIX-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.

Other Name: ENGERIX-B
Biological: Sci-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.

Other Name: Sci-B-Vac

Study Arm (s)

Experimental: ENGERIX-B
Intervention: Biological: ENGERIX-B (HBV Vaccine)
Experimental: Sci-B-Vac
Intervention: Biological: Sci-B-Vac

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2013

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Ohad Etzion, MD

+972-504994721

ohadet@clalit.org.il

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT01531075

Other Study ID Numbers ^ICMJE

sor026511ctil

Has Data Monitoring Committee

Responsible Party

Ohad Etzion, Soroka University Medical Center

Study Sponsor ^ICMJE

Soroka University Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Ohad Etzion, MD

Soroka UMC

Information Provided By

Soroka University Medical Center

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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