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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Hepatitis B

Treatments: Biological: HBV-MPL vaccine Formulation B; Biological: HBV-MPL vaccine Formulation A; Biological: Engerix™-B

Study type: Interventional

Funder types: Industry

Identifiers

NCT00697775

208129/028

Details and patient eligibility

About

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

Full description

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

Enrollment: 200 patients

Sex: All

Ages: 11 to 15 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 4 patient groups

Group A

Experimental group

Description:

HBV-MPL Formulation A at months 0 and 6

Treatment:

Biological: HBV-MPL vaccine Formulation A

Group B

Experimental group

Description:

HBV-MPL Formulation B at months 0 and 6

Treatment:

Biological: HBV-MPL vaccine Formulation B

Group C

Experimental group

Description:

HBV-MPL Formulation A at month 0 and Engerix™-B at month 6

Treatment:

Biological: Engerix™-B

Biological: HBV-MPL vaccine Formulation A

Group D

Active Comparator group

Description:

Engerix™-B at months 0, 1, 6

Treatment:

Biological: Engerix™-B