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CompletedNCT00698906Updated Jun 17, 2008

Comparing Immunogenicity and Safety of Different Formulations of HBV-MPL Vaccine With Engerix™-B in Adults Aged 19-40 y

A Phase 2 interventional study of HBV-MPL vaccine and Engerix™-B in Hepatitis B, sponsored by GlaxoSmithKline. Completed at 1 site in Austria. Open to participants aged 19 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-06-17.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
19 Years to 40 Years
Sex
All
01

Study summary

This study will evaluate the immunogenicity and safety of different formulations of the 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

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
  • HBV-MPL
  • Recombinant Hepatitis B vaccine
03

In context

Hepatitis B

1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.

This study's enrollment of 160 is above the median of 120 across 1,187 interventional studies indexed under Hepatitis B.

Browse Hepatitis B 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
19 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age: between 19 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

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 3 months and during the whole study period
  • Vaccination one month before and one month after each dose of the study vaccine
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
160 participants (actual)

Study arms

  • Experimental
    Group A

    Biological: HBV-MPL vaccine

  • Experimental
    Group B

    Biological: HBV-MPL vaccine

  • Experimental
    Group C

    Biological: HBV-MPL vaccine

  • Experimental
    Group D

    Biological: HBV-MPL vaccine

  • Experimental
    Group E

    Biological: HBV-MPL vaccine

  • Active comparator
    Group F

    Biological: Engerix™-B

Interventions

  • BiologicalHBV-MPL vaccine

    5 different formulations, 2-dose intramuscular injection

  • BiologicalEngerix™-B

    3-dose intramuscular injection

06

What researchers measure

Primary outcomes

  1. Anti-HBs antibody concentrations

    Time frame: Month 7

Secondary outcomes

  1. Anti-HBs antibody concentrations

    Time frame: Month 1, 2 and 6

  2. Occurrence, intensity and relationship to vaccination of solicited local and general symptoms

    Time frame: 4-day follow-up after vaccination

  3. Occurrence, intensity and relationship to vaccination of unsolicited symptoms

    Time frame: 31-day follow-up after vaccination

  4. Incidence of serious adverse events

    Time frame: During the study period

07

Study locations

1 site
  • GSK Clinical Trials Call Center
    Wien, Austria
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
NCT00698906
Lead sponsor
GlaxoSmithKline
First posted
Jun 17, 2008
Start date
Jun 1997
Primary completion
Feb 1998
Last update
Jun 17, 2008

Study contacts

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

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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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