Evaluation of Immunogenicity, Reactogenicity and Safety of HBV-MPL Vaccine vs Engerix™-B, in Haemodialysis Patients

Study Overview
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Brief Summary
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This trial is designed to evaluate the immunogenicity, reactogenicity and safety of an MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in haemodialysis patients with or without previous vaccination against hepatitis B

Detailed Description
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At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Official Title
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Study to Evaluate the Immunogenicity, Reactogenicity and Safety of GSK Biologicals' (Previously SmithKline Beecham Biologicals') MPL-Adjuvanted Recombinant Hepatitis B Vaccine Versus Engerix™-B, in Haemodialysis Patients

Conditions
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Hepatitis B

Intervention / Treatment
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* Biological: HBV-MPL vaccine 208129
* Biological: Engerix™-B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dialysis patients A medical examination including physical examination and medical history as well as serological screening established acceptability for enrollment into the study. Age: from 18 years onwards Seronegative for anti- hepatitis antibodies Exclusion Criteria: History of persistent hepatic, cardiac or respiratory disease Any acute disease at the moment of entry into the study Chronic alcohol consumption Hepatomegaly, right upper quadrant pain or tenderness Any treatment with coticosteroids or immunomodulating drugs Known hypersensitivity to any component of the vaccine Simultaneous participation in any other clinical trial

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A1<br>Non-responders to vaccination after at least 7 previous injections | Biological: Engerix™-B<br>* IM injection<br>|
| Experimental: Group A2<br>Non-responders to vaccination after at least 7 previous injections | Biological: HBV-MPL vaccine 208129<br>* IM injection<br>|
| Active Comparator: Group B1<br>Vaccine-responders requiring a booster dose | Biological: Engerix™-B<br>* IM injection<br>|
| Experimental: Group B2<br>Vaccine-responders requiring a booster dose | Biological: HBV-MPL vaccine 208129<br>* IM injection<br>|
| Active Comparator: Group C1<br>Volunteers participating in the hospital's vaccination program | Biological: Engerix™-B<br>* IM injection<br>|
| Experimental: Group C2<br>Volunteers participating in the hospital's vaccination program | Biological: HBV-MPL vaccine 208129<br>* IM injection<br>|
| Active Comparator: Group D1<br>Unvaccinated haemodialysis patients | Biological: Engerix™-B<br>* IM injection<br>|
| Experimental: Group D2<br>Unvaccinated haemodialysis patients | Biological: HBV-MPL vaccine 208129<br>* IM injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence and intensity of solicited local and general symptoms |  | 4-day follow-up period after each vaccination | 
| Occurrence of unsolicited adverse events |  | During the course of the study | 
| Occurrence of serious adverse events |  | During the course of the study | 
| Anti-HBs antibody concentrations |  | Pre, Day 0, Day 30, Day 60, Day 90, Day 120, D180, D210 depending on group allocation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B, Engerix™-B, Recombinant hepatitis B vaccine, Adjuvant