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CompletedNCT00699231Updated Jun 17, 2008

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

A Phase 1 interventional study of HBV-MPL vaccine 208129 and Engerix™-B in Hepatitis B, sponsored by GlaxoSmithKline. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-06-17.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the detailed description

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

02

Conditions studied

  • Hepatitis B

Keywords

  • Hepatitis B
  • Engerix™-B
  • Recombinant hepatitis B vaccine
  • Adjuvant
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 30 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    Group A1

    Non-responders to vaccination after at least 7 previous injections

    Biological: Engerix™-B

  • Experimental
    Group A2

    Non-responders to vaccination after at least 7 previous injections

    Biological: HBV-MPL vaccine 208129

  • Active comparator
    Group B1

    Vaccine-responders requiring a booster dose

    Biological: Engerix™-B

  • Experimental
    Group B2

    Vaccine-responders requiring a booster dose

    Biological: HBV-MPL vaccine 208129

  • Active comparator
    Group C1

    Volunteers participating in the hospital's vaccination program

    Biological: Engerix™-B

  • Experimental
    Group C2

    Volunteers participating in the hospital's vaccination program

    Biological: HBV-MPL vaccine 208129

  • Active comparator
    Group D1

    Unvaccinated haemodialysis patients

    Biological: Engerix™-B

  • Experimental
    Group D2

    Unvaccinated haemodialysis patients

    Biological: HBV-MPL vaccine 208129

Interventions

  • BiologicalHBV-MPL vaccine 208129

    IM injection

  • BiologicalEngerix™-B

    IM injection

06

What researchers measure

Primary outcomes

  1. Occurrence and intensity of solicited local and general symptoms

    Time frame: 4-day follow-up period after each vaccination

  2. Occurrence of unsolicited adverse events

    Time frame: During the course of the study

  3. Occurrence of serious adverse events

    Time frame: During the course of the study

  4. Anti-HBs antibody concentrations

    Time frame: Pre, Day 0, Day 30, Day 60, Day 90, Day 120, D180, D210 depending on group allocation

07

Study locations

1 site
  • GSK Clinical Trials Call Center
    Brussels, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00699231
Lead sponsor
GlaxoSmithKline
First posted
Jun 17, 2008
Start date
Feb 1992
Primary completion
Dec 1992
Completion
Dec 1992
Last update
Jun 17, 2008

Study contacts

Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.

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