Immunogenicity & Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine With Different Adjuvants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the immunogenicity and reactogenicity of various formulations of recombinant hepatitis B vaccine with different adjuvants in healthy adult volunteers following the 0, 1, 6 months schedule

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

Official Title
-----------------
Study to Evaluate the Immunogenicity and Reactogenicity of Various Formulations of GSK Biologicals' (Previously SmithKline Beecham Biologicals') Recombinant Hepatitis B Vaccine With Different Adjuvants in Healthy Adult Volunteers

Conditions
-----------------
Hepatitis B

Intervention / Treatment
-----------------
* Biological: Engerix™-B
* Biological: HBV-MPL vaccine (208129)
* Biological: Hepatitis B vaccine, experimental formulation


Participation Criteria
=================
Eligibility Criteria
-----------------
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. Serological signs of HBV infection Elevated serum liver enzymes Any vaccination against hepatitis B in the past. Any previous administration of MPL. 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
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br> | Biological: Engerix™-B<br>* Intramuscular injection, 3 doses<br>|
| Experimental: Group B<br> | Biological: Hepatitis B vaccine, experimental formulation<br>* Intramuscular injection, 3 doses<br>|
| Experimental: Group C<br> | Biological: HBV-MPL vaccine (208129)<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence and intensity of solicited local and general symptoms |  | 8 days follow-up after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HBs antibody concentrations |  | Months 0, 1, 3, 6, 7, 8 and 12 | 
| Occurrence, intensity of unsolicited adverse events |  | 30-day follow-up after vaccination | 
| Occurrence of serious adverse events |  | During the study period up to 30 days after last vaccination | 

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