Comparison of Engerix B Vaccine Versus Sci-B-Vac Vaccine in Celiac Patients
Engerix B Versus Sci-B-Vac Immunization in a Celiac Population of Non-responders to Primary Hepatitis B Immunization Series - a Randomized Controlled Trial
1 other identifier
interventional
210
1 country
1
Brief Summary
Celiac disease and infection with hepatitis B virus (HBV) are very prevalent worldwide and carry a high morbidity rate. It has been recently shown that patients with celiac disease very often fail to develop immunity after standard vaccination for HBV during infancy. In this study, we will evaluate whether a second vaccination series with a different vaccine, Sci-B-Vac, results in a better immunological response in celiac patients. Eligible patients will be randomized to receive a 3-dose vaccination series with Engerix or Sci-B-Vac vaccines.. Rate of responders and level of immunity will be compared. This study will facilitate better protection of celiac patients to this potentially deadly virus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2010
CompletedFirst Posted
Study publicly available on registry
July 9, 2010
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedApril 15, 2011
April 1, 2011
1.2 years
July 8, 2010
April 14, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of the geometric mean titers of anti-HBs between the Engerix B group and the Sci-B-Vac group
two years
Secondary Outcomes (6)
Rate of responders four weeks after the completion of the series
two years
Rate and characteristics of adverse drug reactions
two years
Numerical increase in the antibodies titer before and after vaccination
two years
Rate of responders in the cross over phase.
two years
Association between the HBsAg-specific cytokine secreting PBMCs by the ELISPOT assay and vaccine response
two years
- +1 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATORceliac patients who did not respond to initial hepatitis B vaccine series , will receive Sci-B-Vac vaccination series
2
ACTIVE COMPARATORceliac patients who did not respond to initial hepatitis B vaccine series , will receive Engerix 3-dose vaccination series
Interventions
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
A dose of 10mcg (0.5 ml) of the recombinant HBV vaccine will be administered intramuscularly at zero, one and six months intervals
Eligibility Criteria
You may qualify if:
- Patients above 1 year of age with confirmed diagnosis of celiac disease by characteristic symptoms, serology and small bowel biopsy.
- Completion of the IM HBV vaccine series in infancy.
- HBsAb titer of \<10mIU/mL at the time of enrollment.
You may not qualify if:
- Immunocompromised subjects or those receiving medications that may modulate or suppress the immune system (i.e. azathioprine, 6-MP, steroids).
- Inability to obtain written informed consent and patients' assent, as appropriate by the maturity age.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SZMC
Jerusalem, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lena Rachman, MD
Shaheed Ziaur Rahman Medical College
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 8, 2010
First Posted
July 9, 2010
Study Start
April 1, 2011
Primary Completion
June 1, 2012
Study Completion
January 1, 2013
Last Updated
April 15, 2011
Record last verified: 2011-04