Celiac Disease
Conditions
Keywords
Celiac Disease, Hepatitis B vaccination
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.
Interventions
BIOLOGICALHepatitis 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
BIOLOGICALHepatitis 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
Sponsors
Shaare Zedek Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 20 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Rate and characteristics of adverse drug reactions | two years |
| Numerical increase in the antibodies titer before and after vaccination | two years |
| Rate of responders four weeks after the completion of the series | 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 |
| Rate of responders in the cross over phase. | two years |
Countries
Israel
Contacts
Primary ContactMerav Heshin, MD
Backup ContactLena Rachman, MD
Outcome results
None listed