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

July 8, 2010
April 14, 2011
April 2011
June 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01159457 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Comparison of Engerix B Vaccine Versus Sci-B-Vac Vaccine in Celiac Patients
Engerix B Versus Sci-B-Vac Immunization in a Celiac Population of Non-responders to Primary Hepatitis B Immunization Series - a Randomized Controlled Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Celiac Disease
  • 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
  • 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
  • Active Comparator: 1
    celiac patients who did not respond to initial hepatitis B vaccine series , will receive Sci-B-Vac vaccination series
    Intervention: Biological: Hepatitis B vaccination (Sci-B-Vac)
  • Active Comparator: 2
    celiac patients who did not respond to initial hepatitis B vaccine series , will receive Engerix 3-dose vaccination series
    Intervention: Biological: Hepatitis B vaccination (EngerixB)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
210
January 2013
June 2012   (final data collection date for primary outcome measure)

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.
Both
1 Year to 20 Years
No
Contact: Merav Heshin, MD 0508685702 meravheshin@gmail.com
Contact: Lena Rachman, MD 0508685338 jryelanar@gmail.com
Israel
 
NCT01159457
15364.ct.il
Not Provided
Lena Rachman, Shaare Zedek Medical Center
Shaare Zedek Medical Center
Not Provided
Principal Investigator: Lena Rachman, MD SZMC
Shaare Zedek Medical Center
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP