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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Hepatitis B

Treatments: Biological: HBsAg formulated with different concentrations of MPL and Aluminium Salts; Biological: Engerix™-B

Study type: Interventional

Funder types: Industry

Identifiers

NCT00697970

208129/006

Details and patient eligibility

About

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

Full description

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

Enrollment: 321 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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321 participants in 6 patient groups

Group A

Experimental group

Treatment:

Biological: HBsAg formulated with different concentrations of MPL and Aluminium Salts

Group B

Experimental group

Treatment:

Biological: HBsAg formulated with different concentrations of MPL and Aluminium Salts

Group C

Experimental group

Treatment:

Biological: HBsAg formulated with different concentrations of MPL and Aluminium Salts

Group D

Experimental group

Treatment:

Biological: HBsAg formulated with different concentrations of MPL and Aluminium Salts

Group E

Experimental group

Treatment:

Biological: HBsAg formulated with different concentrations of MPL and Aluminium Salts

Group F

Active Comparator group

Treatment:

Biological: Engerix™-B