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

Phase 2

Completed

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

• Registration Number: NCT00697125
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 1993-06
• Primary Completion: 1994-07
• Study Completion: 1994-07
• Status Verified: 2008-06
• Study First Submitted: 2008-06-11
• Study First Submitted QC: 2008-06-11
• Last Update Submitted: 2008-06-11
• Study First Posted: 2008-06-13
• Last Update Posted: 2008-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Engerix™-B	-
Group B	Hepatitis B vaccine, experimental formulation	-
Group C	HBV-MPL vaccine (208129)	-

Primary Outcome Measures

Name	Time	Method
Occurrence and intensity of solicited local and general symptoms	8 days follow-up after vaccination

Secondary Outcome Measures

Name	Time	Method
Anti-HBs antibody concentrations	Months 0, 1, 3, 6, 7, 8 and 12
Occurrence, intensity of unsolicited adverse events	30-day follow-up after vaccination
Occurrence of serious adverse events	During the study period up to 30 days after last vaccination

Trial Locations

Locations (1)

GSK Clinical Trials Call Center; 🇧🇪 Gent, Belgium