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The objective is to assess the efficacy of Hepatitis B Virus vaccination in a population of IBD patients treated with immunosuppressive medications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ENGERIX-B | Experimental |
| |
| Sci-B-Vac | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENGERIX-B (HBV Vaccine) | Biological | ENGERIX-B (Hepatitis B Vaccine) 20 mcg, A series of 3 doses (1 mL each) given on a 0-, 1-, 6-month schedule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| protective level of anti HBs antibodies | Antibody titer >10 IU/ml 30 days following last vaccine dose will be considered protective. In the work done by Altunoz et al., titer rate below 10 IU was observed in 40% of the patients, while 40% of the patients achieved a rate of above 100 IU. Therefore, we can estimate that the geometric mean of distribution is approx. 50 IU. A sample size of 37 patients in each group achieves a power of 80% to detect a ratio above 1.37 between the two vaccinated groups. | 1 month after the last does of vaccine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ohad Etzion, MD | Soroka UMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soroka UMC | Beersheba | 84101 | Israel |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C075654 | Engerix-B |
| C000608755 | Pre-S vaccine |
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| Sci-B-Vac | Biological | Sci-B-Vac (Hepatitis B Vaccine) 10 μg/ml, A series of 3 doses (1 mL each) given on a 0-, 1-, 6-month schedule. |
|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |