Comparison of Immuno, Reacto and Safety of Recombinant Hepatitis B Vaccine With or Without MPL in Healthy Older Adults

Study Overview
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Brief Summary
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In the present study the immunogenicity, reactogenicity and safety of recombinant hepatitis B vaccines with and without MPL will be evaluated in older healthy subjects

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, Safety and Reactogenicity of GSK Biologicals' (Previously SmithKline Beecham Biologicals') Recombinant Hepatitis B Vaccines With and Without Adjuvant in Healthy Older Adult Volunteers

Conditions
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Hepatitis B

Intervention / Treatment
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* Biological: Engerix™-B
* Biological: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or female subjects between 50 and 70 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 Exclusion Criteria: Positive titres for anti hepatitis antibodies Any vaccination against hepatitis B in the past. Any previous administration of MPL Elevated serum liver enzymes at two subsequent determinations 14 days apart. History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease. Axillary temperature > 37.5°C at the time of injection. Any acute disease at the moment of entry. Chronic alcohol consumption. Any treatment with immunosuppressive or immunostimulant therapy. Any chronic drug treatment, 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: 50 Years
Maximum Age: 70 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br> | Biological: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL<br>* Intramuscular injection, 3 doses<br>|
| Experimental: Group B<br> | Biological: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL<br>* Intramuscular injection, 3 doses<br>|
| Experimental: Group C<br> | Biological: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL<br>* Intramuscular injection, 3 doses<br>|
| Active Comparator: Group D<br> | Biological: Engerix™-B<br>* Intramuscular injection, 3 doses<br>|
| Experimental: Group E<br> | Biological: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL<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-hepatitis B surface antigen (HBs) antibody concentrations |  | At M2 and M7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-pre-S1 antibody concentrations |  | Screening, Months 1, 2, 3, 6, 7, 8 and 12, depending on group allocation | 
| Anti-HBs antibody concentrations |  | Screening, Months 1, 2, 3, 6, 7, 8 and 12 | 
| Occurrence and intensity of local and general solicited symptoms |  | 4-day after vaccination | 
| Cell mediated immunity |  | Month 0, Month 2 and month 7 | 
| Occurrence of unsolicited adverse events |  | 30 days after vaccination | 
| Occurrence of serious adverse events |  | During the study period and 30 days after last vaccine dose | 

 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