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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
  Purpose

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


Condition Intervention
Inflammatory Bowel Disease
 Biological: ENGERIX-B (HBV Vaccine)
Biological: Sci-B-Vac

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Assessment of Hepatitis B Vaccination Efficacy in Patients With Inflammatory Bowel Diseases

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • 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.



Estimated Enrollment: 75
Study Start Date: May 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ENGERIX-B 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
Experimental: Sci-B-Vac 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01531075

Contacts
Contact: Ohad Etzion, MD +972-504994721 ohadet@clalit.org.il

Locations
Israel
Soroka UMC Recruiting
Beer- Sheva, Israel, 84101
Contact: Ayala Dvir, M.Sc     +972-86244245        
Sub-Investigator: Olga Abel, MD            
Sponsors and Collaborators
Soroka University Medical Center
Investigators
Principal Investigator: Ohad Etzion, MD Soroka UMC
  More Information

No publications provided

Responsible Party: Ohad Etzion, Senior physician, Department of Gastroenterology and Liver Disease, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT01531075     History of Changes
Other Study ID Numbers: sor026511ctil
Study First Received: February 8, 2012
Last Updated: June 6, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Soroka University Medical Center:
HBV, Inflammatory bowel disease, immunosuppressor

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Inflammatory Bowel Diseases
Intestinal Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Gastroenteritis
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on May 16, 2013