Response to Hepatitis B Vaccine in Celiac Disease Patients

Shaare Zedek Medical Center

Status

Terminated

Conditions

Celiac Disease

Treatments

Biological: hepatitis B vaccine (EngerixB)

Study type

Interventional

Funder types

Other

Identifiers

NCT00739128

15363.ct.il

Details and patient eligibility

About

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.

Enrollment

210 estimated patients

Sex

All

Ages

1+ year old

Volunteers

No 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.