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.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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, 1, 6 Months to That of GSK Biologicals' Adjuvanted Hepatitis B Vaccine Given at 0, 1, 2, 6 Moths in Pre-Dialysis, and Dialysis Patients Who Are Hepatitis B Naive.

Conditions
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Hepatitis B

Intervention / Treatment
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* Biological: Henogen HBV vaccine
* Biological: FENDRIX


Participation Criteria
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Eligibility Criteria
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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

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 HB vaccine | Biological: Henogen HBV vaccine<br>* 20µg, Month 0, 2 and 6<br>|
| Active Comparator: 2<br>Fendrix vaccine | Biological: FENDRIX<br>* 20 µg,Months 0, 1, 2 and 6<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HBs seroprotection rate at Month 2. |  | Month 0 and 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HBs antibody concentrations |  | Months 0, 1, 2, 3, 6 and 7 | 
| Anti-HBs seroprotection rates for all subjects. |  | Months 0, 1, 2, 3, 6 and 7 | 
| Anti-HBs seropositivity rates for all subjects |  | Months 0, 1, 2, 3, 6 and 7 | 
| Percentage of subjects with anti-HBs antibody concentrations equal or greater than 100 mIU/ml for all subjects. |  | Months 0, 1, 2, 3, 6 and 7 | 
| Anti-HBs geometric mean concentrations calculated for all subjects. |  | Months 0, 1, 2, 3, 6 and 7 | 
| Anti-RF-1 seropositivity rates (defined as the percentage of subjects with anti-RF-1 like antibody concentrations superior or equal to 33 EU/ml, the assay cut-off) in a random subset of 50 subjects per group. |  | Months 0 and 7 | 
| Anti-RF-1 like antibody geometric mean concentration in a random subset of 50 subjects per group. |  | Month 0 and 7 | 
| Occurrence and intensity of solicited local signs and symptoms, as well as occurrence, intensity and relationship to vaccination of solicited general signs and symptoms during a 4-day follow-up (i.e. Day 0 to Day 3) after each vaccination and overall. |  | Month 0, 1, 2, 3, 6 and 7 | 
| Occurrence, intensity and relationship to vaccination of unsolicited symptoms reported during the 31-day (Day 0 to Day 30) follow-up period after each vaccination and overall. |  | Month 0, 1, 2, 3, 6 and 7 | 
| Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 7. |  | Month 0 to 7 | 

 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