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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:
ClinicalTrials.gov Identifier:
NCT00739128
First Posted: August 21, 2008
Last Update Posted: April 15, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shaare Zedek Medical Center
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Ari Silbermintz, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00739128     History of Changes
Other Study ID Numbers: 15363.ct.il
First Submitted: August 20, 2008
First Posted: August 21, 2008
Last Update Posted: April 15, 2011
Last Verified: April 2011

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

Additional relevant MeSH terms:
Celiac Disease
Hepatitis
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Metabolic Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs