Hepatitis B Vaccine in Patients With Inflammatory Bowel Disease (HBV VIP)
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ClinicalTrials.gov Identifier: NCT01531075 |
Recruitment Status :
Completed
First Posted : February 10, 2012
Last Update Posted : April 21, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Inflammatory Bowel Disease | Biological: ENGERIX-B (HBV Vaccine) Biological: Sci-B-Vac | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 91 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Assessment of Hepatitis B Vaccination Efficacy in Patients With Inflammatory Bowel Diseases |
Actual Study Start Date : | April 2012 |
Actual Primary Completion Date : | August 2015 |
Actual Study Completion Date : | August 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: ENGERIX-B |
Biological: ENGERIX-B (HBV Vaccine)
ENGERIX-B (Hepatitis B Vaccine) 20 mcg, A series of 3 doses (1 mL each) given on a 0-, 1-, 6-month schedule.
Other Name: ENGERIX-B |
Experimental: Sci-B-Vac |
Biological: Sci-B-Vac
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. |
- protective level of anti HBs antibodies [ Time Frame: 1 month after the last does of vaccine ]
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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male/female ≥ 18 years of age
- Evidence of IBD as diagnosed by clinical, laboratory imaging and endoscopic criteria.
- Treated with at least one immunosuppressive medication at the time of study initiation
- Provided written informed consent.
Exclusion Criteria:
- Pregnant women
- Diagnosis of chronic viral hepatitis B
- Any major acute medical event in the 30 days prior to recruitment that necessitated hospitalization ( acute myocardial infarction, CVA, pulmonary emboli, sepsis, major trauma)
- Any other chronic inflammatory condition not related to IBD ( connective tissue disease, Chronic liver disease, COPD, poorly controlled diabetes mellitus)
- Active hematologic or oncologic diseases

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01531075
Israel | |
Soroka UMC | |
Beer- Sheva, Israel, 84101 |
Principal Investigator: | Ohad Etzion, MD | Soroka UMC |
Responsible Party: | Ohad Etzion, Senior physician, Department of Gastroenterology and Liver Disease, Soroka University Medical Center |
ClinicalTrials.gov Identifier: | NCT01531075 |
Other Study ID Numbers: |
sor026511ctil |
First Posted: | February 10, 2012 Key Record Dates |
Last Update Posted: | April 21, 2020 |
Last Verified: | April 2020 |
HBV, Inflammatory bowel disease, immunosuppressor |
Hepatitis B Intestinal Diseases Inflammatory Bowel Diseases Hepatitis Liver Diseases Digestive System Diseases |
Hepadnaviridae Infections DNA Virus Infections Virus Diseases Hepatitis, Viral, Human Gastrointestinal Diseases Gastroenteritis |