Comparison of Engerix B Vaccine Versus Sci-B-Vac Vaccine in Celiac Patients

Not Applicable

• Conditions: Celiac Disease
• Interventions: Biological: Hepatitis B vaccination (Sci-B-Vac); Biological: Hepatitis B vaccination (EngerixB)

• Registration Number: NCT01159457
• 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 with a different vaccine, Sci-B-Vac, results in a better immunological response in celiac patients. Eligible patients will be randomized to receive a 3-dose vaccination series with Engerix or Sci-B-Vac vaccines.. 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: 2010-07-08
• Study First Submitted QC: 2010-07-08
• Study First Posted: 2010-07-09
• Status Verified: 2011-04
• Study Start: 2011-04
• Last Update Submitted: 2011-04-14
• Last Update Posted: 2011-04-15
• Primary Completion: 2012-06
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• 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. azathioprine, 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 vaccination (Sci-B-Vac)	celiac patients who did not respond to initial hepatitis B vaccine series , will receive Sci-B-Vac vaccination series
2	Hepatitis B vaccination (EngerixB)	celiac patients who did not respond to initial hepatitis B vaccine series , will receive Engerix 3-dose vaccination series

Primary Outcome Measures

Name	Time	Method
Comparison of the geometric mean titers of anti-HBs between the Engerix B group and the Sci-B-Vac group	two years

Secondary Outcome Measures

Name	Time	Method
Numerical increase in the antibodies titer before and after vaccination	two years
Association between the HBsAg-specific cytokine secreting PBMCs by the ELISPOT assay and vaccine response	two years
Rate of responders four weeks after the completion of the series	two years
Rate and characteristics of adverse drug reactions	two years
Rate of responders in the cross over phase.	two years
Association between genetic make-up and vaccine response	two years

Trial Locations

Locations (1)

SZMC; 🇮🇱 Jerusalem, Israel