Comparison of Engerix B Vaccine Versus Sci-B-Vac Vaccine in Celiac Patients
NCT ID: NCT01159457
Last Updated: 2011-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
210 participants
INTERVENTIONAL
2011-04-30
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
celiac patients who did not respond to initial hepatitis B vaccine series , will receive Sci-B-Vac vaccination series
Hepatitis B vaccination (Sci-B-Vac)
A dose of 5mcg (0.5 ml) (up to 10yr old) and 10mcg (1.0 ml)(above 10yr old) of the recombinant HBV vaccine will be administered intramuscularly at zero, one and six months intervals
2
celiac patients who did not respond to initial hepatitis B vaccine series , will receive Engerix 3-dose vaccination series
Hepatitis B vaccination (EngerixB)
A dose of 10mcg (0.5 ml) of the recombinant HBV vaccine will be administered intramuscularly at zero, one and six months intervals
Interventions
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Hepatitis B vaccination (Sci-B-Vac)
A dose of 5mcg (0.5 ml) (up to 10yr old) and 10mcg (1.0 ml)(above 10yr old) of the recombinant HBV vaccine will be administered intramuscularly at zero, one and six months intervals
Hepatitis B vaccination (EngerixB)
A dose of 10mcg (0.5 ml) of the recombinant HBV vaccine will be administered intramuscularly at zero, one and six months intervals
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Completion of the IM HBV vaccine series in infancy.
* HBsAb titer of \<10mIU/mL at the time of enrollment.
Exclusion Criteria
* Inability to obtain written informed consent and patients' assent, as appropriate by the maturity age.
1 Year
20 Years
ALL
No
Sponsors
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Shaare Zedek Medical Center
OTHER
Responsible Party
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Shaare Zedek Medical Center
Principal Investigators
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Lena Rachman, MD
Role: PRINCIPAL_INVESTIGATOR
Shaheed Ziaur Rahman Medical College
Locations
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SZMC
Jerusalem, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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15364.ct.il
Identifier Type: -
Identifier Source: org_study_id
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