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Completed

NCT Number: NCT00698555

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

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

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Clinical Trials Call Center

Ghent, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HBV-MPL vaccine

Biological

5 different formulations, 2-dose intramuscular injection

Engerix™-B

Biological

3-dose intramuscular injection

Primary outcomes

  1. Anti-HBs antibody concentrations

    Time frame: Month 7

Secondary outcomes

  1. Anti-HBs antibody concentrations

    Time frame: Month 1, 2, 6 and 12

  2. Cell mediated immunity

    Time frame: Month 1, 2, 6, 7 and 12

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

    Time frame: 4-day follow-up after vaccination

  4. Occurrence and intensity and relationship to vaccination of unsolicited symptoms

    Time frame: 31-day follow-up after vaccination

  5. Incidence of SAE

    Time frame: Throughout the study period

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
1997
Primary completion
1998
First posted
Jun 17, 2008
Registry last updated
Jun 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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