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

A Multicentric, Randomised Study Comparing the Immunogenicity and Safety of Henogen's Adjuvanted Hepatitis B Vaccine Given at 0, 1months to That of Aventis Pasteur MSD's Hepatitis B Given at 0, 1 Months in Pre-Dialysis, and Dialysis Patients Did Not Respond to Previous Hepatitis B Vaccination

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00291954

Enrollment

257

Registered

2006-02-15

Start date

2006-03-31

Completion date

2007-10-31

Last updated

2008-08-28

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

Conditions

Hepatitis B

Keywords

Dialysis, Pre-dialysis, Hepatitis B vaccine, Prophylaxis hepatitis B infection

Brief summary

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.

Detailed 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.

Interventions

BIOLOGICALHB-AS02V

HB-AS02V (20µg HBsAg) will be administered at Month 0 and 1

BIOLOGICALHBVAXPRO vaccine

HBVAXPRO vaccine (40µg HBsAg) will be administered at Month 0 and 1

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Anti-HBs seroprotection rate	Month 2

Secondary

Measure	Time frame
Anti-HBs Seropositivity rates for all subjects.	Months 0, 1 and 2
Percentage of subjects with anti-HBs antibody concentrations superior or equal to 100 mIU/ml for all subjects	Months 0, 1 and 2
Anti-HBs Geometric Mean Concentrations calculated for all subjects.	Months 0, 1 and 2
Anti-HBs Seroprotection rates for all subjects.	Months 0, 1 and 2
Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms during the 31-day (Day 0 to Day 30) follow-up period after each vaccination and overall	Month 0, 1 and 2
Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 2	Month 0 to 2
Occurrence and intensity of solicited local signs and symptoms, relationship to vaccination of solicited general signs and symptoms reported during the 4-day follow-up period after each vaccination and overall	Month 0, 1 and 2

Countries

Belgium, Czechia, Hungary

Outcome results

None listed

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