Response to Hepatitis B Vaccine in Celiac Disease Patients

Not Applicable

Terminated

• Conditions: Celiac Disease
• Interventions: Biological: hepatitis B vaccine (EngerixB)

• Registration Number: NCT00739128
• Lead Sponsor: Shaare Zedek Medical Center

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 available

Study Timeline

• Study First Submitted: 2008-08-20
• Study First Submitted QC: 2008-08-20
• Study First Posted: 2008-08-21
• Study Start: 2009-02
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-14
• Last Update Posted: 2011-04-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 210

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	hepatitis B vaccine (EngerixB)	celiac patients who did not respond to initial hepatitis B vaccine series , will receive repeat hep B vaccine via intramuscular route
2	hepatitis B vaccine (EngerixB)	celiac patients who did not respond to initial hepatitis B vaccine series , will receive repeat hep B vaccine via intradermal route

Primary Outcome Measures

Name	Time	Method
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.	two years

Secondary Outcome Measures

Name	Time	Method
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	two years

Trial Locations

Locations (1)

SZMC; 🇮🇱 Jerusalem, Israel