Evaluation of Immunogenicity, Reactogenicity and Safety of HBV-MPL Vaccine vs Engerix™-B, in Haemodialysis Patients

Study to Evaluate the Immunogenicity, Reactogenicity and Safety of GSK Biologicals' (Previously SmithKline Beecham Biologicals') MPL-Adjuvanted Recombinant Hepatitis B Vaccine Versus Engerix™-B, in Haemodialysis Patients

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00699231

Enrollment

Registered

2008-06-17

Start date

1992-02-29

Completion date

1992-12-31

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, Engerix™-B, Recombinant hepatitis B vaccine, Adjuvant

Brief summary

This trial is designed to evaluate the immunogenicity, reactogenicity and safety of an MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in haemodialysis patients with or without previous vaccination against hepatitis B

Detailed description

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

Interventions

BIOLOGICALEngerix™-B

IM injection

BIOLOGICALHBV-MPL vaccine 208129

IM injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Dialysis patients * A medical examination including physical examination and medical history as well as serological screening established acceptability for enrollment into the study. * Age: from 18 years onwards * Seronegative for anti- hepatitis antibodies

Exclusion criteria

* History of persistent hepatic, cardiac or respiratory disease * Any acute disease at the moment of entry into the study * Chronic alcohol consumption * Hepatomegaly, right upper quadrant pain or tenderness * Any treatment with coticosteroids or immunomodulating drugs * Known hypersensitivity to any component of the vaccine * Simultaneous participation in any other clinical trial

Design outcomes

Primary

Measure	Time frame
Occurrence and intensity of solicited local and general symptoms	4-day follow-up period after each vaccination
Occurrence of unsolicited adverse events	During the course of the study
Occurrence of serious adverse events	During the course of the study
Anti-HBs antibody concentrations	Pre, Day 0, Day 30, Day 60, Day 90, Day 120, D180, D210 depending on group allocation

Countries

Belgium

Outcome results

None listed

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