Comparing Immunogenicity and Safety of Different Formulations of HBV-MPL Vaccine With Engerix™-B in Adults Aged 18-40 y

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the immunogenicity and safety of different formulations of the candidate HBV-MPL vaccine administered according to a 2-dose schedule and compare it to that of Engerix™-B administered according to a 3-dose schedule in order to determine the optimal dose of each component of the candidate HBV-MPL vaccine when administered at 0 and 6 months

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

Official Title
-----------------
Study Comparing the Immunogenicity and Reactogenicity of Different Formulations of GSK Bio's HBV-MPL Vaccine Injected as a 0, 6 Months Schedule With That of Engerix™-B Injected as a 0, 1, 6 Months Schedule in Healthy Adults Aged 18-40 Years

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: between 18 and 40 years old. 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 titres at screening for anti-hepatitis 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 a hepatitis B vaccine. Previous vaccination with an MPL containing vaccine. Administration of immunoglobulins in the past 6 months and during the whole study period Vaccination one month before and one month after each dose of the study vaccine

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br> | Biological: HBV-MPL vaccine<br>* 5 different formulations, 2-dose intramuscular injection<br>|
| Experimental: Group B<br> | Biological: HBV-MPL vaccine<br>* 5 different formulations, 2-dose intramuscular injection<br>|
| Experimental: Group C<br> | Biological: HBV-MPL vaccine<br>* 5 different formulations, 2-dose intramuscular injection<br>|
| Experimental: Group D<br> | Biological: HBV-MPL vaccine<br>* 5 different formulations, 2-dose intramuscular injection<br>|
| Experimental: Group E<br> | Biological: HBV-MPL vaccine<br>* 5 different formulations, 2-dose intramuscular injection<br>|
| Active Comparator: Group F<br> | Biological: Engerix™-B<br>* 3-dose intramuscular injection<br>|

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

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HBs antibody concentrations |  | Month 1, 2, 6 and 12 | 
| Cell mediated immunity |  | Month 1, 2, 6, 7 and 12 | 
| Occurrence and intensity and relationship to vaccination of solicited local and general symptoms |  | 4-day follow-up after vaccination | 
| Occurrence and intensity and relationship to vaccination of unsolicited symptoms |  | 31-day follow-up after vaccination | 
| Incidence of SAE |  | Throughout the study period | 

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