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

Study Overview
=================
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.

Official Title
-----------------
Engerix B Versus Sci-B-Vac Immunization in a Celiac Population of Non-responders to Primary Hepatitis B Immunization Series - a Randomized Controlled Trial

Conditions
-----------------
Celiac Disease

Intervention / Treatment
-----------------
* Biological: Hepatitis B vaccination (Sci-B-Vac)
* Biological: Hepatitis B vaccination (EngerixB)


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>celiac patients who did not respond to initial hepatitis B vaccine series , will receive Sci-B-Vac vaccination series | Biological: Hepatitis B vaccination (Sci-B-Vac)<br>* A dose of 5mcg (0.5 ml) (up to 10yr old) and 10mcg (1.0 ml)(above 10yr old) of the recombinant HBV vaccine will be administered intramuscularly at zero, one and six months intervals<br>|
| Active Comparator: 2<br>celiac patients who did not respond to initial hepatitis B vaccine series , will receive Engerix 3-dose vaccination series | Biological: Hepatitis B vaccination (EngerixB)<br>* A dose of 10mcg (0.5 ml) of the recombinant HBV vaccine will be administered intramuscularly at zero, one and six months intervals<br>* Other names: GSK;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Celiac Disease, Hepatitis B vaccination