Status:
UNKNOWN
Comparison of Engerix B Vaccine Versus Sci-B-Vac Vaccine in Celiac Patients
Lead Sponsor:
Shaare Zedek Medical Center
Conditions:
Celiac Disease
Eligibility:
All Genders
1-20 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- Immunocompromised subjects or those receiving medications that may modulate or suppress the immune system (i.e. azathioprine, 6-MP, steroids).
- Inability to obtain written informed consent and patients' assent, as appropriate by the maturity age.
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2013
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT01159457
Start Date
April 1 2011
End Date
January 1 2013
Last Update
April 15 2011
Active Locations (1)
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1
SZMC
Jerusalem, Israel