Response to Hepatitis B Vaccine in Celiac Disease Patients
Primary Purpose
Celiac Disease
Status
Terminated
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
hepatitis B vaccine (EngerixB)
hepatitis B vaccine (EngerixB)
Sponsored by
About this trial
This is an interventional treatment trial for Celiac Disease focused on measuring celiac disease, hepatitis B vaccine
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Immunocompromised subjects or those receiving medications that may modulate or suppress the immune system (i.e. azathiopurine, 6-MP, steroids).
- Inability to obtain written informed consent and patients' assent, as appropriate by the maturity age.
Sites / Locations
- SZMC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
celiac patients who did not respond to initial hepatitis B vaccine series , will receive repeat hep B vaccine via intramuscular route
celiac patients who did not respond to initial hepatitis B vaccine series , will receive repeat hep B vaccine via intradermal route
Outcomes
Primary Outcome Measures
1. The primary endpoint of the study will be comparison of the geometric mean titers of anti-HBs between the intradermal and the intramuscular groups.
Secondary Outcome Measures
1. Rate of responders four weeks after the completion of the series 2. Rate and characteristics of adverse drug reactions 3. Numerical increase in the antibodies titer before and after vaccination 4. Rate of responders in the cross over phase
Full Information
NCT ID
NCT00739128
First Posted
August 20, 2008
Last Updated
April 14, 2011
Sponsor
Shaare Zedek Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00739128
Brief Title
Response to Hepatitis B Vaccine in Celiac Disease Patients
Official Title
Intradermal Immunization Against Hepatitis B Virus in Celiac Disease- a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Terminated
Why Stopped
Believed that a better study was to compare the response to engerix B vs Sci-B-Vac vaccine in this patient group.
Study Start Date
February 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Shaare Zedek Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 via a different route of administration (into the skin rather than the muscle) results in a better immunological response in celiac patients. Eligible patients will be randomized to receive a 3-dose vaccination series into the skin or to the muscle. Rate of responders and level of immunity will be compared. This study will facilitate better protection of celiac patients to this potentially deadly virus.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease
Keywords
celiac disease, hepatitis B vaccine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
celiac patients who did not respond to initial hepatitis B vaccine series , will receive repeat hep B vaccine via intramuscular route
Arm Title
2
Arm Type
Active Comparator
Arm Description
celiac patients who did not respond to initial hepatitis B vaccine series , will receive repeat hep B vaccine via intradermal route
Intervention Type
Biological
Intervention Name(s)
hepatitis B vaccine (EngerixB)
Other Intervention Name(s)
EngerixB, GSK
Intervention Description
A dose of 10mcg (0.5 ml) of the recombinant HBV vaccine will be administered intramuscular at zero, one and six months intervals
Intervention Type
Biological
Intervention Name(s)
hepatitis B vaccine (EngerixB)
Other Intervention Name(s)
(EngerixB, GSK)
Intervention Description
A dose of 10mcg (0.5 ml) of the recombinant HBV vaccine will be administered intradermally in the deltoid region at zero, one and six months intervals
Primary Outcome Measure Information:
Title
1. The primary endpoint of the study will be comparison of the geometric mean titers of anti-HBs between the intradermal and the intramuscular groups.
Time Frame
two years
Secondary Outcome Measure Information:
Title
1. Rate of responders four weeks after the completion of the series 2. Rate and characteristics of adverse drug reactions 3. Numerical increase in the antibodies titer before and after vaccination 4. Rate of responders in the cross over phase
Time Frame
two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Immunocompromised subjects or those receiving medications that may modulate or suppress the immune system (i.e. azathiopurine, 6-MP, steroids).
Inability to obtain written informed consent and patients' assent, as appropriate by the maturity age.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maskit Bar Meir, MD
Organizational Affiliation
Shaheed Ziaur Rahman Medical College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ari Silbermintz
Organizational Affiliation
Shaheed Ziaur Rahman Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
SZMC
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
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Response to Hepatitis B Vaccine in Celiac Disease Patients
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