Hepatitis B Vaccine in Patients With Inflammatory Bowel Disease (HBV VIP)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Soroka University Medical Center.
Recruitment status was Recruiting
Information provided by (Responsible Party):
Ohad Etzion, Soroka University Medical Center
First received: February 8, 2012
Last updated: June 6, 2012
Last verified: June 2012
The objective is to assess the efficacy of Hepatitis B Virus vaccination in a population of IBD patients treated with immunosuppressive medications.
Inflammatory Bowel Disease
Biological: ENGERIX-B (HBV Vaccine)
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
||Assessment of Hepatitis B Vaccination Efficacy in Patients With Inflammatory Bowel Diseases
Primary Outcome Measures:
- protective level of anti HBs antibodies [ Time Frame: 1 month after the last does of vaccine ] [ Designated as safety issue: No ]
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.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2012 (Final data collection date for primary outcome measure)
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
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.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01531075
|Beer- Sheva, Israel, 84101 |
|Contact: Ayala Dvir, M.Sc +972-86244245 |
|Sub-Investigator: Olga Abel, MD |
Soroka University Medical Center
||Ohad Etzion, MD
||Ohad Etzion, Senior physician, Department of Gastroenterology and Liver Disease, Soroka University Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 8, 2012
||June 6, 2012
||Israel: Ministry of Health
Keywords provided by Soroka University Medical Center:
HBV, Inflammatory bowel disease, immunosuppressor
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 25, 2016
Inflammatory Bowel Diseases
DNA Virus Infections
Hepatitis, Viral, Human
Digestive System Diseases
Physiological Effects of Drugs