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

Shaare Zedek Medical Center

Status: Unknown

Conditions: Celiac Disease

Treatments: Biological: Hepatitis B vaccination (EngerixB); Biological: Hepatitis B vaccination (Sci-B-Vac)

Study type: Interventional

Funder types: Other

Identifiers

NCT01159457

15364.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 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.

Enrollment: 210 estimated patients

Sex: All

Ages: 1 to 20 years 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. azathioprine, 6-MP, steroids).
• Inability to obtain written informed consent and patients' assent, as appropriate by the maturity age.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

1

Active Comparator group

Description:

celiac patients who did not respond to initial hepatitis B vaccine series , will receive Sci-B-Vac vaccination series

Treatment:

Biological: Hepatitis B vaccination (Sci-B-Vac)

2

Active Comparator group

Description:

celiac patients who did not respond to initial hepatitis B vaccine series , will receive Engerix 3-dose vaccination series

Treatment:

Biological: Hepatitis B vaccination (EngerixB)