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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Soroka University Medical Center.
Recruitment status was  Recruiting
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

February 8, 2012
June 6, 2012
May 2012
December 2012   (final data collection date for primary outcome measure)
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.

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.
Complete list of historical versions of study NCT01531075 on ClinicalTrials.gov Archive Site
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Hepatitis B Vaccine in Patients With Inflammatory Bowel Disease
Assessment of Hepatitis B Vaccination Efficacy in Patients With Inflammatory Bowel Diseases

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Inflammatory Bowel Disease
  • 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
  • Experimental: ENGERIX-B
    Intervention: Biological: ENGERIX-B (HBV Vaccine)
  • Experimental: Sci-B-Vac
    Intervention: Biological: Sci-B-Vac
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
March 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Ohad Etzion, MD +972-504994721 ohadet@clalit.org.il
Israel
 
NCT01531075
sor026511ctil
No
Ohad Etzion, Soroka University Medical Center
Soroka University Medical Center
Not Provided
Principal Investigator: Ohad Etzion, MD Soroka UMC
Soroka University Medical Center
June 2012

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