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Response to Hepatitis B Vaccine in Celiac Disease Patients

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ClinicalTrials.gov Identifier: NCT00739128
Recruitment Status : Terminated (Believed that a better study was to compare the response to engerix B vs Sci-B-Vac vaccine in this patient group.)
First Posted : August 21, 2008
Last Update Posted : April 15, 2011
Sponsor:
Information provided by:
Shaare Zedek Medical Center

Tracking Information
First Submitted Date  ICMJE August 20, 2008
First Posted Date  ICMJE August 21, 2008
Last Update Posted Date April 15, 2011
Study Start Date  ICMJE February 2009
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2008)
1. The primary endpoint of the study will be comparison of the geometric mean titers of anti-HBs between the intradermal and the intramuscular groups. [ Time Frame: two years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2008)
1. Rate of responders four weeks after the completion of the series 2. Rate and characteristics of adverse drug reactions 3. Numerical increase in the antibodies titer before and after vaccination 4. Rate of responders in the cross over phase [ Time Frame: two years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Response to Hepatitis B Vaccine in Celiac Disease Patients
Official Title  ICMJE Intradermal Immunization Against Hepatitis B Virus in Celiac Disease- a Randomized Controlled Trial
Brief Summary Celiac disease and infection with hepatitis B virus (HBV) are very prevalent worldwide and carry a high morbidity rate. It has been recently shown that patients with celiac disease very often fail to develop immunity after standard vaccination for HBV during infancy. In this study, we will evaluate whether a second vaccination series via a different route of administration (into the skin rather than the muscle) results in a better immunological response in celiac patients. Eligible patients will be randomized to receive a 3-dose vaccination series into the skin or to the muscle. Rate of responders and level of immunity will be compared. This study will facilitate better protection of celiac patients to this potentially deadly virus.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Celiac Disease
Intervention  ICMJE
  • Biological: hepatitis B vaccine (EngerixB)
    A dose of 10mcg (0.5 ml) of the recombinant HBV vaccine will be administered intramuscular at zero, one and six months intervals
    Other Name: EngerixB, GSK
  • Biological: hepatitis B vaccine (EngerixB)
    A dose of 10mcg (0.5 ml) of the recombinant HBV vaccine will be administered intradermally in the deltoid region at zero, one and six months intervals
    Other Name: (EngerixB, GSK)
Study Arms  ICMJE
  • Active Comparator: 1
    celiac patients who did not respond to initial hepatitis B vaccine series , will receive repeat hep B vaccine via intramuscular route
    Intervention: Biological: hepatitis B vaccine (EngerixB)
  • Active Comparator: 2
    celiac patients who did not respond to initial hepatitis B vaccine series , will receive repeat hep B vaccine via intradermal route
    Intervention: Biological: hepatitis B vaccine (EngerixB)
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 Terminated
Estimated Enrollment  ICMJE
 (submitted: August 20, 2008)
210
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients above 1 year of age with confirmed diagnosis of celiac disease by characteristic symptoms, serology and small bowel biopsy.
  • Completion of the IM HBV vaccine series in infancy.
  • HBsAb titer of ≤10mIU/mL at the time of enrollment.

Exclusion Criteria:

  • Immunocompromised subjects or those receiving medications that may modulate or suppress the immune system (i.e. azathiopurine, 6-MP, steroids).
  • Inability to obtain written informed consent and patients' assent, as appropriate by the maturity age.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00739128
Other Study ID Numbers  ICMJE 15363.ct.il
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ari Silbermintz, Shaare Zedek Medical Center
Study Sponsor  ICMJE Shaare Zedek Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maskit Bar Meir, MD Shaheed Ziaur Rahman Medical College
Principal Investigator: Ari Silbermintz Shaheed Ziaur Rahman Medical College
PRS Account Shaare Zedek Medical Center
Verification Date April 2011

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