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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Shaare Zedek Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT01159457
First received: July 8, 2010
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 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.


Condition Intervention
Celiac Disease
 Biological: Hepatitis B vaccination (Sci-B-Vac)
Biological: Hepatitis B vaccination (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: Engerix B Versus Sci-B-Vac Immunization in a Celiac Population of Non-responders to Primary Hepatitis B Immunization Series - 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:
  • Comparison of the geometric mean titers of anti-HBs between the Engerix B group and the Sci-B-Vac group [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of responders four weeks after the completion of the series [ Time Frame: two years ] [ Designated as safety issue: Yes ]
  • Rate and characteristics of adverse drug reactions [ Time Frame: two years ] [ Designated as safety issue: Yes ]
  • Numerical increase in the antibodies titer before and after vaccination [ Time Frame: two years ] [ Designated as safety issue: Yes ]
  • Rate of responders in the cross over phase. [ Time Frame: two years ] [ Designated as safety issue: Yes ]
  • Association between the HBsAg-specific cytokine secreting PBMCs by the ELISPOT assay and vaccine response [ Time Frame: two years ] [ Designated as safety issue: No ]
  • Association between genetic make-up and vaccine response [ Time Frame: two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 210
Study Start Date: April 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: June 2012 (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 Sci-B-Vac vaccination series
 Biological: Hepatitis B vaccination (Sci-B-Vac)
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
Active Comparator: 2
celiac patients who did not respond to initial hepatitis B vaccine series , will receive Engerix 3-dose vaccination series
 Biological: Hepatitis B vaccination (EngerixB)
A dose of 10mcg (0.5 ml) of the recombinant HBV vaccine will be administered intramuscularly at zero, one and six months intervals
Other Name: GSK

  Eligibility

Ages Eligible for Study:   1 Year to 20 Years
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. azathioprine, 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: NCT01159457

Contacts
Contact: Merav Heshin, MD 0508685702 meravheshin@gmail.com
Contact: Lena Rachman, MD 0508685338 jryelanar@gmail.com

Locations
Israel
SZMC Recruiting
Jerusalem, Israel
Contact: Merav Heshin, MD     0508685702     meravheshin@gmail.com    
Contact: Lena Rachman, MD     0508685338     jryelanar@gmail.com    
Principal Investigator: Lena Rachman, MD            
Sub-Investigator: Merav Heshin, MD            
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Lena Rachman, MD SZMC
  More Information

No publications provided

Responsible Party: Lena Rachman, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT01159457     History of Changes
Other Study ID Numbers: 15364.ct.il
Study First Received: July 8, 2010
Last Updated: April 14, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Shaare Zedek Medical Center:
Celiac Disease
Hepatitis B vaccination

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on May 23, 2013