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

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ClinicalTrials.gov Identifier: NCT01531075
Recruitment Status : Unknown
Verified June 2012 by Ohad Etzion, Soroka University Medical Center.
Recruitment status was:  Recruiting
First Posted : February 10, 2012
Last Update Posted : June 7, 2012
Sponsor:
Information provided by (Responsible Party):
Ohad Etzion, Soroka University Medical Center

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

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease Biological: ENGERIX-B (HBV Vaccine) Biological: Sci-B-Vac Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Assessment of Hepatitis B Vaccination Efficacy in Patients With Inflammatory Bowel Diseases
Study Start Date : May 2012
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. protective level of anti HBs antibodies [ Time Frame: 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: February 10, 2012    Key Record Dates
Last Update Posted: June 7, 2012
Last Verified: June 2012

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

Additional relevant MeSH terms:
Hepatitis B
Intestinal Diseases
Inflammatory Bowel Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases
Gastrointestinal Diseases
Gastroenteritis
Vaccines
Immunologic Factors
Physiological Effects of Drugs