Safety and Immunogenicity of GSK Bio's Candidate HBV-MPL Vaccines Compared to Engerix™-B, in Healthy Adolescents

Study Overview
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Brief Summary
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In this study the safety and immunogenicity of 2 different formulations of the candidate HBV-MPL vaccine administered according to a 0, 6-month schedule were explored and compared to that of Engerix™-B in healthy adolescents aged 11 to 15

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 Assess the Feasibility of GSK Bio's Candidate HBV / MPL Vaccines Following Different Schedules and Formulations and to Compare Their Safety and Immunogenicity to That of Engerix™-B in Healthy Adolescents Aged 11 to 15

Conditions
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Hepatitis B

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: between 11 and 15 years at the time of the first vaccination. Free of obvious health problems as established by medical history and clinical examination before entering into the study. Written informed consent obtained from the parents or guardians of the subject and from the subject himself/herself in all subjects 15 years of age. If the subject is female, she must be of non-childbearing potential, if of childbearing potential, she must be abstinent or have used an adequate contraceptive for one month prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series Exclusion Criteria: Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine. Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination. Planned administration of a vaccine not foreseen by the study protocol during the period starting from one week before each dose of vaccine and ending 30 days after. Previous vaccination against hepatitis B virus. Previous vaccination with vaccine containing MPL. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Acute disease at the time of enrollment. Hepatomegaly, right upper quadrant abdominal pain or tenderness. Axillary temperature of ≥ 37.5° C. Administration of immunoglobulin and / or any blood product within the six months preceding the first dose of study vaccine or planned administration during the study period. Pregnant or lactating female. History of chronic disease deemed by the investigator to be relevant. Positive for anti-HBV antibodies at screening

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 15 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>HBV-MPL Formulation A at months 0 and 6 | Biological: HBV-MPL vaccine Formulation A<br>* Single dose (when extemporaneously co-administered with Engerix™-B) or 2-dose (when administered alone) intramuscular injection<br>|
| Experimental: Group B<br>HBV-MPL Formulation B at months 0 and 6 | Biological: HBV-MPL vaccine Formulation B<br>* 2-dose intramuscular injection<br>|
| Experimental: Group C<br>HBV-MPL Formulation A at month 0 and Engerix™-B at month 6 | Biological: HBV-MPL vaccine Formulation A<br>* Single dose (when extemporaneously co-administered with Engerix™-B) or 2-dose (when administered alone) intramuscular injection<br>Biological: Engerix™-B<br>* Single dose (when extemporaneously co-administered with HBV-MPL) or 3-dose (when administered alone) intramuscular injection<br>|
| Active Comparator: Group D<br>Engerix™-B at months 0, 1, 6 | Biological: Engerix™-B<br>* Single dose (when extemporaneously co-administered with HBV-MPL) or 3-dose (when administered alone) intramuscular injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Serious adverse experiences (SAE) |  | During the study period | 
| Occurrence, intensity and relationship to vaccination of solicited local and general symptoms |  | During the 8-day follow-up period after vaccination | 
| Occurrence, intensity and causal relationship of unsolicited adverse events |  | 31-day follow-up period after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HBs antibody concentrations |  | At months 1, 2, 6, and 7 | 
| Cell mediated immunity |  | At months 1, 6, and 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B, Recombinant hepatitis B vaccine, Adjuvant