Immunogenicity & Reactogenicity of HBV-MPL Vaccine and Engerix™-B in Healthy Adults Following 2 Different Schedules

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, immunogenicity and reactogenicity of MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in healthy adult volunteers following two different schedules: 0, 2 months and 0, 6 months

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 and Reactogenicity of GSK Biologicals' MPL-Adjuvanted Recombinant Hepatitis B Vaccine in Comparison With Those of Engerix™-B in Healthy Adult Volunteers Following 2 Different Schedules

Conditions
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Hepatitis B

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 18 and 40 years old. Written informed consent will have been obtained from the subjects. Good physical condition as established by physical examination and history taking at the time of entry. Female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry. Exclusion Criteria: Positive titres for anti hepatitis B antibodies. Any vaccination against hepatitis B in the past. Elevated serum liver enzymes. History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease. Axillary temperature > 37°C at the time of injection. Any acute disease at the moment of entry. Chronic alcohol consumption. 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. Administration of any other vaccine(s) or any immunoglobulin during the study period. Simultaneous participation in any other clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Subjects will receive HBV-MPL vaccine in the primary schedule 0, 2 months and will receive a booster dose of HBV-MPL vaccine at 70 months | Biological: HBV-MPL vaccine<br>* Intramuscular injection, 1 or 3 doses<br>|
| Experimental: Group B<br>Subjects will receive HBV-MPL vaccine in the primary schedule 0, 2 months and will receive a booster dose of Engerix™-B vaccine at 70 months | Biological: Engerix™-B<br>* Intramuscular injection, 1 or 3 doses<br>Biological: HBV-MPL vaccine<br>* Intramuscular injection, 1 or 3 doses<br>|
| Experimental: Group C<br>Subjects will receive Engerix™-B vaccine in the primary schedule 0, 2 months and will receive a booster dose of HBV-MPL vaccine at 70 months | Biological: Engerix™-B<br>* Intramuscular injection, 1 or 3 doses<br>|
| Experimental: Group D<br>Subjects will receive Engerix™-B vaccine in the primary schedule 0, 2 months and will receive a booster dose of Engerix™-B vaccine at 70 months | Biological: Engerix™-B<br>* Intramuscular injection, 1 or 3 doses<br>Biological: HBV-MPL vaccine<br>* Intramuscular injection, 1 or 3 doses<br>|
| Experimental: Group E<br>Subjects will receive HBV-MPL vaccine in the primary schedule 0, 6 months and will receive a booster dose of HBV-MPL vaccine at 70 months | Biological: HBV-MPL vaccine<br>* Intramuscular injection, 1 or 3 doses<br>|
| Experimental: Group F<br>Subjects will receive HBV-MPL vaccine in the primary schedule 0, 6 months and will receive a booster dose of Engerix™-B vaccine at 70 months | Biological: Engerix™-B<br>* Intramuscular injection, 1 or 3 doses<br>Biological: HBV-MPL vaccine<br>* Intramuscular injection, 1 or 3 doses<br>|
| Experimental: Group G<br>Subjects will receive Engerix™-B vaccine in the primary schedule 0, 6 months and will receive a booster dose of HBV-MPL vaccine at 70 months | Biological: Engerix™-B<br>* Intramuscular injection, 1 or 3 doses<br>|
| Experimental: Group H<br>Subjects will receive Engerix™-B vaccine in the primary schedule 0, 6 months and will receive a booster dose of Engerix™-B vaccine at 70 months | Biological: Engerix™-B<br>* Intramuscular injection, 1 or 3 doses<br>Biological: HBV-MPL vaccine<br>* Intramuscular injection, 1 or 3 doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-hepatitis B surface antigen (HBs) antibody concentrations |  | One month after the full primary vaccination course and one month after the booster vaccination at 70 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HBs antibody concentrations |  | Months 1, 2, 3, 6, 12, 13, 42 | 
| Serious adverse experiences (SAE). |  | Throughout the study period | 
| Occurrence and intensity of solicited local symptoms |  | 8-day follow-up after vaccination | 
| Occurrence, intensity and relationship of solicited general symptoms |  | 8-day follow-up after vaccination | 
| Incidence of unsolicited symptoms |  | During the 30-day follow-up after vaccination | 

 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