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

Condition(s) targeted: Hepatitis B

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

Phase: Phase 2

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Primary outcome: Occurrence and intensity of solicited local and general symptoms

Secondary outcome:

Anti-HBs antibody concentrations

Occurrence, intensity of unsolicited adverse events

Occurrence of serious adverse events

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

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Both.

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.

GSK Clinical Trials Call Center, Gent, Belgium

Starting date: June 1993
Last updated: June 11, 2008