Compare the Immune Response & Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine vs Aventis Pasteur MSD's Hepatitis B Vaccine in Pre-Dialysis & Dialysis Patients Who Did Not Respond to Previous Hepatitis B Vaccination

Henogen

Status and phase

Completed

Phase 3

Conditions

Hepatitis B

Treatments

Biological: HB-AS02V

Biological: HBVAXPRO vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00291954

HN017/HBV-003 (105762)

Details and patient eligibility

About

Hepatitis B prevention in non-responders uraemic patients is currently based on both HBsAg surveillance and the isolation from HBsAg carriers. A more immunogenic vaccine would be a benefit for this population.

Full description

Study participants will receive either Henogen's adjuvanted hepatitis B vaccine or Aventis Pasteur's hepatitis B vaccine. The study involves a total of 4 visits and blood samples will taken at each of these visits.

Enrollment

257 patients

Sex

All

Ages

15+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

A male or female subject greater than or equal to 15 years of age at the time of study entry
Written informed consent obtained from the subject/ from the parent or guardian of the subject.
Seronegative for anti-HBc antibodies and for HBsAg at screening.
Pre-dialysis patients, peritoneal dialysis patients or haemodialysis patients
Documented evidence of previous hepatitis B vaccination with at least one full primary vaccination course of minimum four injections of licensed vaccine.
The last dose should have been administered at least two months before the planned first dose of study vaccine in this study.
Documented evidence of non-response to previous hepatitis B vaccination after at least one to maximum three months after the last vaccine dose.

Exclusion criteria

Subject included on HN014/HBV-001 study. History of Hepatitis B infection Use of immunoglobulins within six months preceding the first study vaccination.
Any confirmed or suspected human immunodeficiency virus (HIV) infection. Pregnant or lactating female