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

• Rate of responders four weeks after the completion of the series [ Time Frame: two years ] [ Designated as safety issue: Yes ]
• Rate and characteristics of adverse drug reactions [ Time Frame: two years ] [ Designated as safety issue: Yes ]
• Numerical increase in the antibodies titer before and after vaccination [ Time Frame: two years ] [ Designated as safety issue: Yes ]
• Rate of responders in the cross over phase. [ Time Frame: two years ] [ Designated as safety issue: Yes ]
• Association between the HBsAg-specific cytokine secreting PBMCs by the ELISPOT assay and vaccine response [ Time Frame: two years ] [ Designated as safety issue: No ]
• Association between genetic make-up and vaccine response [ Time Frame: two years ] [ Designated as safety issue: No ]

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.

• Biological: Hepatitis B vaccination (Sci-B-Vac)
  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
• Biological: Hepatitis B vaccination (EngerixB)
  A dose of 10mcg (0.5 ml) of the recombinant HBV vaccine will be administered intramuscularly at zero, one and six months intervals
  Other Name: GSK

• Active Comparator: 1
  celiac patients who did not respond to initial hepatitis B vaccine series , will receive Sci-B-Vac vaccination series
  Intervention: Biological: Hepatitis B vaccination (Sci-B-Vac)
• Active Comparator: 2
  celiac patients who did not respond to initial hepatitis B vaccine series , will receive Engerix 3-dose vaccination series
  Intervention: Biological: Hepatitis B vaccination (EngerixB)

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.