Response to Hepatitis B Vaccine in Celiac Disease Patients

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00739128

Enrollment

210

Registered

2008-08-21

Start date

2009-02-28

Completion date

2011-03-31

Last updated

2011-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celiac Disease

Keywords

celiac disease, hepatitis B vaccine

Brief 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.

Interventions

BIOLOGICALhepatitis 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026