Response to Hepatitis B Vaccine in Celiac Disease Patients

Celiac Disease Clinical Trial

Official title:

Intradermal Immunization Against Hepatitis B Virus in Celiac Disease- a Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00739128
• Other study ID #: 15363.ct.il
• Status: Terminated
• Phase: N/A
• First received: August 20, 2008
• Last updated: April 14, 2011
• Start date: February 2009
• Est. completion date: March 2011

Study information

• Verified date: April 2011
• Source: Shaare Zedek Medical Center
• Contact: n/a
• 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 210
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year and older

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. azathiopurine, 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
• Hepatitis B

Intervention

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
• 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

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	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.		two years	No
Secondary	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		two years	Yes