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
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
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
|Beer- Sheva, Israel, 84101|
|Principal Investigator:||Ohad Etzion, MD||Soroka UMC|