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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
210
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
A dose of 10mcg (0.5 ml) of the recombinant HBV vaccine will be administered intramuscularly at zero, one and six months intervals
SZMC
Jerusalem, Israel
RECRUITINGComparison of the geometric mean titers of anti-HBs between the Engerix B group and the Sci-B-Vac group
Time frame: two years
Rate of responders four weeks after the completion of the series
Time frame: two years
Rate and characteristics of adverse drug reactions
Time frame: two years
Numerical increase in the antibodies titer before and after vaccination
Time frame: two years
Rate of responders in the cross over phase.
Time frame: two years
Association between the HBsAg-specific cytokine secreting PBMCs by the ELISPOT assay and vaccine response
Time frame: two years
Association between genetic make-up and vaccine response
Time frame: two years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.