Comparing Immunogenicity and Safety of Different Formulations of HBV-MPL Vaccine With Engerix™-B in Adults Aged 18-40 y

Study Comparing the Immunogenicity and Reactogenicity of Different Formulations of GSK Bio's HBV-MPL Vaccine Injected as a 0, 6 Months Schedule With That of Engerix™-B Injected as a 0, 1, 6 Months Schedule in Healthy Adults Aged 18-40 Years

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00698555

Enrollment

163

Registered

2008-06-17

Start date

1997-03-31

Completion date

Unknown

Last updated

2008-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B

Keywords

Hepatitis B, HBV-MPL, Recombinant hepatitis B vaccine

Brief summary

This study will evaluate the immunogenicity and safety of different formulations of the candidate HBV-MPL vaccine administered according to a 2-dose schedule and compare it to that of Engerix™-B administered according to a 3-dose schedule in order to determine the optimal dose of each component of the candidate HBV-MPL vaccine when administered at 0 and 6 months

Detailed description

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

Interventions

BIOLOGICALHBV-MPL vaccine

5 different formulations, 2-dose intramuscular injection

BIOLOGICALEngerix™-B

3-dose intramuscular injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* Age: between 18 and 40 years old. * Good physical condition as established by clinical examination and history taking at the time of entry. * Female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period. * Written informed consent obtained from the subjects

Exclusion criteria

* Positive titres at screening for anti-hepatitis antibodies. * Elevated serum liver enzymes * History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease. * Any acute disease at the moment of entry. * Chronic alcohol consumption. * Hepatomegaly, right upper quadrant abdominal pain or tenderness. * Any chronic drug treatment, including any treatment with immunosuppressive drugs, 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. * Simultaneous participation in any other clinical trial. * Previous vaccination with a hepatitis B vaccine. * Previous vaccination with an MPL containing vaccine. * Administration of immunoglobulins in the past 6 months and during the whole study period * Vaccination one month before and one month after each dose of the study vaccine

Design outcomes

Primary

Measure	Time frame
Anti-HBs antibody concentrations	Month 7

Secondary

Measure	Time frame
Anti-HBs antibody concentrations	Month 1, 2, 6 and 12
Cell mediated immunity	Month 1, 2, 6, 7 and 12
Occurrence and intensity and relationship to vaccination of solicited local and general symptoms	4-day follow-up after vaccination
Occurrence and intensity and relationship to vaccination of unsolicited symptoms	31-day follow-up after vaccination
Incidence of SAE	Throughout the study period

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026