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Response to Hepatitis B Vaccine in Celiac Disease Patients

This study has been terminated.
(Believed that a better study was to compare the response to engerix B vs Sci-B-Vac vaccine in this patient group.)
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00739128
First received: August 20, 2008
Last updated: April 14, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention
Celiac Disease
 Biological: hepatitis B vaccine (EngerixB)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intradermal Immunization Against Hepatitis B Virus in Celiac Disease- a Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shaare Zedek Medical Center:

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. [ Time Frame: two years ] [ Designated as safety issue: No ]

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 [ Time Frame: two years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 210
Study Start Date: February 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
celiac patients who did not respond to initial hepatitis B vaccine series , will receive repeat hep B vaccine via intramuscular route
 Biological: hepatitis B vaccine (EngerixB)
A dose of 10mcg (0.5 ml) of the recombinant HBV vaccine will be administered intramuscular at zero, one and six months intervals
Other Name: EngerixB, GSK
Active Comparator: 2
celiac patients who did not respond to initial hepatitis B vaccine series , will receive repeat hep B vaccine via intradermal route
 Biological: hepatitis B vaccine (EngerixB)
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
Other Name: (EngerixB, GSK)

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00739128

Locations
Israel
SZMC
Jerusalem, Israel
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Maskit Bar Meir, MD SZMC
Principal Investigator: Ari Silbermintz SZMC
  More Information

No publications provided

Responsible Party: Ari Silbermintz, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00739128     History of Changes
Other Study ID Numbers: 15363.ct.il
Study First Received: August 20, 2008
Last Updated: April 14, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Shaare Zedek Medical Center:
celiac disease
hepatitis B vaccine

Additional relevant MeSH terms:
Celiac Disease
Hepatitis
Hepatitis A
Hepatitis B
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases
 Liver Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on May 16, 2013