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

Celiac Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01159457
• Other study ID #: 15364.ct.il
• Status: Recruiting
• Phase: N/A
• First received: July 8, 2010
• Last updated: April 14, 2011
• Start date: April 2011
• Est. completion date: January 2013

Study information

• Verified date: April 2011
• Source: Shaare Zedek Medical Center
• Contact: Merav Heshin, MD
• Phone: 0508685702
• Email: meravheshin[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: January 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 20 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Celiac Disease

Intervention

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
• 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

Locations

Country	Name	City	State
Israel	SZMC	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the geometric mean titers of anti-HBs between the Engerix B group and the Sci-B-Vac group		two years	No
Secondary	Rate of responders four weeks after the completion of the series		two years	Yes
Secondary	Rate and characteristics of adverse drug reactions		two years	Yes
Secondary	Numerical increase in the antibodies titer before and after vaccination		two years	Yes
Secondary	Rate of responders in the cross over phase.		two years	Yes
Secondary	Association between the HBsAg-specific cytokine secreting PBMCs by the ELISPOT assay and vaccine response		two years	No
Secondary	Association between genetic make-up and vaccine response		two years	No