Evaluation of Immunogenicity and Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine

Study Overview
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Brief Summary
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The purpose of the present trial is to evaluate 6 vaccine formulations of recombinant hepatitis B vaccine for their reactogenicity and immunogenicity when administered at 0-2 months with a booster at month 12

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 Various Formulations of GSK Biologicals' (Previously SmithKline Beecham Biologicals') Recombinant Hepatitis B Vaccine in Healthy Adult Volunteers

Conditions
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Hepatitis B

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


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: Pregnancy or lactation. Positivity for anti hepatitis antibodies. Any vaccination against hepatitis B in the past. Any previous administration of MPL. Elevated serum liver enzymes. 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: 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br> | Biological: HBsAg formulated with different concentrations of MPL and Aluminium Salts<br>* Intramuscular injection, 3 doses<br>|
| Experimental: Group B<br> | Biological: HBsAg formulated with different concentrations of MPL and Aluminium Salts<br>* Intramuscular injection, 3 doses<br>|
| Experimental: Group C<br> | Biological: HBsAg formulated with different concentrations of MPL and Aluminium Salts<br>* Intramuscular injection, 3 doses<br>|
| Experimental: Group D<br> | Biological: HBsAg formulated with different concentrations of MPL and Aluminium Salts<br>* Intramuscular injection, 3 doses<br>|
| Experimental: Group E<br> | Biological: HBsAg formulated with different concentrations of MPL and Aluminium Salts<br>* Intramuscular injection, 3 doses<br>|
| Active Comparator: Group F<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 |  | After two doses and after the booster dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence and intensity of local and general solicited symptoms |  | 8 days after vaccination | 
| Anti-HBs antibody concentrations |  | Screening, M1, 2, 3, 4, 6, 12, 13 | 
| Occurrence of unsolicited adverse events |  | 30-day after vaccination | 
| Occurrence of serious adverse events |  | During the study period and 30 days after the last 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, Adjuvant