A Study to Compare the Immune Response and Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine Compared to GSK Biologicals Adjuvanted Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Have Not Been Exposed to Hepatitis B.

Henogen

Status and phase

Completed

Phase 3

Conditions

Hepatitis B

Treatments

Biological: FENDRIX

Biological: Henogen HBV vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00291941

HN014/HBV-001 (105757)

Details and patient eligibility

About

The pre-dialysis, peritoneal dialysis and haemodialysis patients would benefit from an improved hepatitis B vaccine, which will elicit stronger and faster cellular and humoral immune responses after the primary vaccination course.

Full description

Study participants will receive either Henogen's adjuvanted hepatitis B vaccine or GSK Biologicals' adjuvanted hepatitis B vaccine. The study involves a total of 7 visits and blood samples will taken at each of these visits.

Enrollment

300 patients

Sex

All

Ages

15+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

A male or female subject 15 years of age or older at the time of the study entry.
Written informed consent obtained from the subject/ from the parent or guardian of the subject.
Seronegative for anti-HBs antibodies, anti-HBc antibodies and for HBsAg at screening.
Pre-dialysis patients, peritoneal dialysis patients or haemodialysis patients.
Non-childbearing potential female

Exclusion criteria

Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Use of any registered vaccine within 7 days before the first dose of study vaccine.
Previous vaccination against hepatitis B (whether or not the subject responded to the vaccine).
History of hepatitis B infection.
Known exposure to hepatitis B virus within 6 months.
Use of immunoglobulins within six months preceding the first study vaccination.
Immunosuppression caused by the administration of parenteral steroids or chemotherapy (oral steroids are allowed).
Any confirmed or suspected human immunodeficiency virus (HIV) infection.
A family history of congenital or hereditary immunodeficiency.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral/ axillary temperature < 37.5°C (or 37 °C in Czech Republic).
Oral/axillary temperature superior or equal to 37.5°C (or 37 °C in Czech Republic).
Pregnant or lactating female