Study Evaluating Persistence of Anti-HBs Antibodies in Uraemic Patients Receiving Henogen's HBV Vaccine, or Fendrix™

Study Overview
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Brief Summary
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The current extension study will assess the persistence of anti-HBs antibodies at Months 12, 24 and 36 after primary vaccination with Henogen's HBV vaccine or Fendrix™. This protocol posting deals with the objectives & outcome measures of the extension phase at Months 12, 24 and 36. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00291941).

Detailed Description
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Subjects who received complete full vaccination with Henogen HBV adjuvanted vaccine or Fendrix™ will participate in this persistence study for three long-term time points (12, 24 and 36 months after the first dose of primary vaccination). Blood sampling will be done at each time point to measure immune persistence.

Official Title
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A Study to Evaluate the Persistence of Anti-HBs Antibodies at Months 12, 24 and 36 in Pre-dialysis or Dialysis Patients Who Have Received a Primary Vaccination Course of Either Henogen's HBV Vaccine, HB-AS02V or GSK Biological's Fendrix™

Conditions
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Hepatitis B

Intervention / Treatment
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* Biological: Henogen HB vaccine
* Biological: Fendrix vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent obtained from the subject/ from the parent/ guardian of the subject. Subjects who completed the full course of primary vaccination. Exclusion Criteria: Immunosuppression caused by the administration of parenteral steroids or chemotherapy. Any confirmed or suspected human immunodeficiency virus (HIV) infection.

Ages Eligible for Study
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Minimum Age: 16 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 for uremic patients | Biological: Henogen HB vaccine<br>* Month 12, 24 and 36<br>|
| Active Comparator: 2<br>Fendrix hepatitis B vaccine for uremic patients | Biological: Fendrix vaccine<br>* Month 12, 24 and 36<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HBs antibody concentrations |  | Months 12, 24 and 36. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of immune response |  | Month 12, 24 and 36 | 
| SAEs retrospective reporting |  | Month 12, 24 and 36 | 
| RF-1 like antibody concentrations in the subset of subjects for whom this analysis was done at the primary study (HN014/HBV-001). |  | Month 12, 24 and 36 | 

 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, vaccine