Response to Hepatitis B Vaccine in Celiac Disease Patients
Information source: Shaare Zedek Medical Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Celiac Disease
Intervention: hepatitis B vaccine (EngerixB) (Biological); hepatitis B vaccine (EngerixB) (Biological)
Phase: N/A
Status: Terminated
Sponsored by: Shaare Zedek Medical Center Official(s) and/or principal investigator(s):
Maskit Bar Meir, MD, Principal Investigator, Affiliation: SZMC
Ari Silbermintz, Principal Investigator, Affiliation: SZMC
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.
Clinical Details
Official title: Intradermal Immunization Against Hepatitis B Virus in Celiac Disease- a Randomized Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: 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
Eligibility
Minimum age: 1 Year.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
SZMC, Jerusalem, Israel
Additional Information
Starting date: February 2009
Last updated: April 14, 2011
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