Hepatitis B Vaccine in Patients With Inflammatory Bowel Disease (HBV VIP)
|ClinicalTrials.gov Identifier: NCT01531075|
Recruitment Status : Unknown
Verified June 2012 by Ohad Etzion, Soroka University Medical Center.
Recruitment status was: Recruiting
First Posted : February 10, 2012
Last Update Posted : June 7, 2012
|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)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment of Hepatitis B Vaccination Efficacy in Patients With Inflammatory Bowel Diseases|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||March 2013|
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01531075
|Contact: Ohad Etzion, MDfirstname.lastname@example.org|
|Beer- Sheva, Israel, 84101|
|Contact: Ayala Dvir, M.Sc +972-86244245|
|Sub-Investigator: Olga Abel, MD|
|Principal Investigator:||Ohad Etzion, MD||Soroka UMC|