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Response to Hepatitis B Vaccine in Celiac Disease Patients

This study has been terminated.
(Believed that a better study was to compare the response to engerix B vs Sci-B-Vac vaccine in this patient group.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00739128
First Posted: August 21, 2008
Last Update Posted: April 15, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shaare Zedek Medical Center
August 20, 2008
August 21, 2008
April 15, 2011
February 2009
March 2011   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00739128 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Response to Hepatitis B Vaccine in Celiac Disease Patients
Intradermal Immunization Against Hepatitis B Virus in Celiac Disease- a Randomized Controlled Trial
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Celiac Disease
  • 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)
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
210
March 2011
March 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
1 Year and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00739128
15363.ct.il
No
Not Provided
Not Provided
Ari Silbermintz, Shaare Zedek Medical Center
Shaare Zedek Medical Center
Not Provided
Principal Investigator: Maskit Bar Meir, MD SZMC
Principal Investigator: Ari Silbermintz SZMC
Shaare Zedek Medical Center
April 2011

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