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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hepatitis B

Intervention / Treatment
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* Biological: HB-AS02V
* Biological: HBVAXPRO vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Henogen hepatitis B vaccine | Biological: HB-AS02V<br>* HB-AS02V (20µg HBsAg) will be administered at Month 0 and 1<br>|
| Active Comparator: 2<br>HBVAXPRO hepatitis B vaccine | Biological: HBVAXPRO vaccine<br>* HBVAXPRO vaccine (40µg HBsAg) will be administered at Month 0 and 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HBs seroprotection rate |  | Month 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HBs Seroprotection rates for all subjects. |  | Months 0, 1 and 2 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dialysis, Pre-dialysis, Hepatitis B vaccine, Prophylaxis hepatitis B infection