Immunogenicity and Reactogenicity of MPL Adjuvanted Recombinant Hepatitis B- Vaccine and Engerix™-B in Adult Non-Responders

Study Overview
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Brief Summary
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The purpose of this study is to compare the immunogenicity and reactogenicity of the adjuvanted recombinant hepatitis B vaccine with that of Engerix™-B when both are injected according to a three dose schedule (0, 1, 6 months) in an adult non-responder population

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 Compare the Immunogenicity and Reactogenicity of GSK Biologicals; (Previously SmithKline Beecham Biologicals') MPL-Adjuvanted Recombinant Hepatitis B Vaccine With That of Engerix™-B in an Adult Non-Responder Population

Conditions
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Hepatitis B

Intervention / Treatment
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* Biological: Recombinant MPL- adjuvanted hepatitis B vaccine
* Biological: Engerix™-B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: older than 18 years of age. Documented non-responders 2 to 5 months after having received 4 doses of a hepatitis B vaccine Good physical condition as established by clinical examination and history taking at the time of entry. Female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period. Written informed consent obtained from the subjects Exclusion Criteria: Positive at screening for anti-HBV antibodies Elevated serum liver enzymes. History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease. Any acute disease at the moment of entry. Chronic alcohol consumption. Hepatomegaly, right upper quadrant abdominal pain or tenderness. Any chronic drug treatment, including any treatment with immunosuppressive drugs, which in the investigator's opinion, precludes inclusion into the study. History of allergic disease likely to be stimulated by any component of the vaccine. Simultaneous participation in any other clinical trial. Previous vaccination with an MPL containing vaccine. Administration of immunoglobulins 6 months before and during the whole study period Vaccination one month before and one month after each dose of the study vaccine

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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Accepts Healthy Volunteers

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br> | Biological: Recombinant MPL- adjuvanted hepatitis B vaccine<br>* Intramuscular injection, 3 doses<br>|
| Active Comparator: Group B<br> | Biological: Engerix™-B<br>* Intramuscular injection, 3 doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HBs antibody concentrations |  | At month 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HBs antibody concentrations |  | At months 2, 6, 7 and 12 | 
| Occurrence and intensity of solicited local symptoms |  | 4-day follow-up after vaccination | 
| Occurrence, intensity and relationship of solicited general symptoms |  | 4-day follow-up after vaccination | 
| Occurrence, intensity and relationship to vaccination of unsolicited symptoms |  | Within 30 days after vaccination | 
| Incidence of serious AEs |  | Throughout the entire study up to and including 30 days after the last vaccination | 
| Cell mediated immunity |  | At months 0, 2, 6, 7, 12 | 

 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