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Comparison of Engerix B Vaccine Versus Sci-B-Vac Vaccine in Celiac Patients

Primary Purpose

Celiac Disease

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Hepatitis B vaccination (Sci-B-Vac)
Hepatitis B vaccination (EngerixB)
Sponsored by
Shaare Zedek Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Celiac Disease focused on measuring Celiac Disease, Hepatitis B vaccination

Eligibility Criteria

1 Year - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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. azathioprine, 6-MP, steroids).
  • Inability to obtain written informed consent and patients' assent, as appropriate by the maturity age.

Sites / Locations

  • SZMCRecruiting

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 Sci-B-Vac vaccination series

celiac patients who did not respond to initial hepatitis B vaccine series , will receive Engerix 3-dose vaccination series

Outcomes

Primary Outcome Measures

Comparison of the geometric mean titers of anti-HBs between the Engerix B group and the Sci-B-Vac group

Secondary Outcome Measures

Rate of responders four weeks after the completion of the series
Rate and characteristics of adverse drug reactions
Numerical increase in the antibodies titer before and after vaccination
Rate of responders in the cross over phase.
Association between the HBsAg-specific cytokine secreting PBMCs by the ELISPOT assay and vaccine response
Association between genetic make-up and vaccine response

Full Information

First Posted
July 8, 2010
Last Updated
April 14, 2011
Sponsor
Shaare Zedek Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01159457
Brief Title
Comparison of Engerix B Vaccine Versus Sci-B-Vac Vaccine in Celiac Patients
Official Title
Engerix B Versus Sci-B-Vac Immunization in a Celiac Population of Non-responders to Primary Hepatitis B Immunization Series - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
January 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Shaare Zedek Medical Center

4. Oversight

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 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.

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 vaccination

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 Sci-B-Vac vaccination series
Arm Title
2
Arm Type
Active Comparator
Arm Description
celiac patients who did not respond to initial hepatitis B vaccine series , will receive Engerix 3-dose vaccination series
Intervention Type
Biological
Intervention Name(s)
Hepatitis B vaccination (Sci-B-Vac)
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Hepatitis B vaccination (EngerixB)
Other Intervention Name(s)
GSK
Intervention Description
A dose of 10mcg (0.5 ml) of the recombinant HBV vaccine will be administered intramuscularly at zero, one and six months intervals
Primary Outcome Measure Information:
Title
Comparison of the geometric mean titers of anti-HBs between the Engerix B group and the Sci-B-Vac group
Time Frame
two years
Secondary Outcome Measure Information:
Title
Rate of responders four weeks after the completion of the series
Time Frame
two years
Title
Rate and characteristics of adverse drug reactions
Time Frame
two years
Title
Numerical increase in the antibodies titer before and after vaccination
Time Frame
two years
Title
Rate of responders in the cross over phase.
Time Frame
two years
Title
Association between the HBsAg-specific cytokine secreting PBMCs by the ELISPOT assay and vaccine response
Time Frame
two years
Title
Association between genetic make-up and vaccine response
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
20 Years
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. azathioprine, 6-MP, steroids). Inability to obtain written informed consent and patients' assent, as appropriate by the maturity age.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Merav Heshin, MD
Phone
0508685702
Email
meravheshin@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lena Rachman, MD
Phone
0508685338
Email
jryelanar@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lena Rachman, MD
Organizational Affiliation
Shaheed Ziaur Rahman Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
SZMC
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Merav Heshin, MD
Phone
0508685702
Email
meravheshin@gmail.com
First Name & Middle Initial & Last Name & Degree
Lena Rachman, MD
Phone
0508685338
Email
jryelanar@gmail.com
First Name & Middle Initial & Last Name & Degree
Lena Rachman, MD
First Name & Middle Initial & Last Name & Degree
Merav Heshin, MD

12. IPD Sharing Statement

Learn more about this trial

Comparison of Engerix B Vaccine Versus Sci-B-Vac Vaccine in Celiac Patients

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