Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | celiac patients who did not respond to initial hepatitis B vaccine series , will receive Sci-B-Vac vaccination series |
|
| 2 | Active Comparator | celiac patients who did not respond to initial hepatitis B vaccine series , will receive Engerix 3-dose vaccination series |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hepatitis B vaccination (Sci-B-Vac) | Biological | 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 |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Merav Heshin, MD | Contact | 0508685702 | meravheshin@gmail.com | |
| Lena Rachman, MD | Contact | 0508685338 | jryelanar@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Lena Rachman, MD | Shaheed Ziaur Rahman Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SZMC | Recruiting | Jerusalem | Israel |
Not provided
| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Hepatitis B vaccination (EngerixB) | Biological | A dose of 10mcg (0.5 ml) of the recombinant HBV vaccine will be administered intramuscularly at zero, one and six months intervals |
|
|
| 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 |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |