Immunogenicity & Reactogenicity of HBV-MPL Vaccine and Engerix™-B in Healthy Adults Following 2 Different Schedules

June 11, 2008 updated by: GlaxoSmithKline

Study to Evaluate the Immunogenicity and Reactogenicity of GSK Biologicals' MPL-Adjuvanted Recombinant Hepatitis B Vaccine in Comparison With Those of Engerix™-B in Healthy Adult Volunteers Following 2 Different Schedules

The purpose of this study is to evaluate the safety, immunogenicity and reactogenicity of MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in healthy adult volunteers following two different schedules: 0, 2 months and 0, 6 months

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Wilrijk, Belgium
        • GSK Clinical Trials Call Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Between 18 and 40 years old.
  • Written informed consent will have been obtained from the subjects.
  • Good physical condition as established by physical examination and history taking at the time of entry.
  • Female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry.

Exclusion Criteria:

  • Positive titres for anti hepatitis B antibodies.
  • Any vaccination against hepatitis B in the past.
  • Elevated serum liver enzymes.
  • History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
  • Axillary temperature > 37°C at the time of injection.
  • Any acute disease at the moment of entry.
  • Chronic alcohol consumption.
  • 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.
  • Administration of any other vaccine(s) or any immunoglobulin during the study period.
  • Simultaneous participation in any other clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group A
Subjects will receive HBV-MPL vaccine in the primary schedule 0, 2 months and will receive a booster dose of HBV-MPL vaccine at 70 months
Biological: HBV-MPL vaccine
Intramuscular injection, 1 or 3 doses
EXPERIMENTAL: Group B
Subjects will receive HBV-MPL vaccine in the primary schedule 0, 2 months and will receive a booster dose of Engerix™-B vaccine at 70 months
Biological: HBV-MPL vaccine
Intramuscular injection, 1 or 3 doses
Biological: Engerix™-B
Intramuscular injection, 1 or 3 doses
EXPERIMENTAL: Group C
Subjects will receive Engerix™-B vaccine in the primary schedule 0, 2 months and will receive a booster dose of HBV-MPL vaccine at 70 months
Biological: Engerix™-B
Intramuscular injection, 1 or 3 doses
EXPERIMENTAL: Group D
Subjects will receive Engerix™-B vaccine in the primary schedule 0, 2 months and will receive a booster dose of Engerix™-B vaccine at 70 months
Biological: HBV-MPL vaccine
Intramuscular injection, 1 or 3 doses
Biological: Engerix™-B
Intramuscular injection, 1 or 3 doses
EXPERIMENTAL: Group E
Subjects will receive HBV-MPL vaccine in the primary schedule 0, 6 months and will receive a booster dose of HBV-MPL vaccine at 70 months
Biological: HBV-MPL vaccine
Intramuscular injection, 1 or 3 doses
EXPERIMENTAL: Group F
Subjects will receive HBV-MPL vaccine in the primary schedule 0, 6 months and will receive a booster dose of Engerix™-B vaccine at 70 months
Biological: HBV-MPL vaccine
Intramuscular injection, 1 or 3 doses
Biological: Engerix™-B
Intramuscular injection, 1 or 3 doses
EXPERIMENTAL: Group G
Subjects will receive Engerix™-B vaccine in the primary schedule 0, 6 months and will receive a booster dose of HBV-MPL vaccine at 70 months
Biological: Engerix™-B
Intramuscular injection, 1 or 3 doses
EXPERIMENTAL: Group H
Subjects will receive Engerix™-B vaccine in the primary schedule 0, 6 months and will receive a booster dose of Engerix™-B vaccine at 70 months
Biological: HBV-MPL vaccine
Intramuscular injection, 1 or 3 doses
Biological: Engerix™-B
Intramuscular injection, 1 or 3 doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anti-hepatitis B surface antigen (HBs) antibody concentrations
Time Frame: One month after the full primary vaccination course and one month after the booster vaccination at 70 months
One month after the full primary vaccination course and one month after the booster vaccination at 70 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Anti-HBs antibody concentrations
Time Frame: Months 1, 2, 3, 6, 12, 13, 42
Months 1, 2, 3, 6, 12, 13, 42
Serious adverse experiences (SAE).
Time Frame: Throughout the study period
Throughout the study period
Occurrence and intensity of solicited local symptoms
Time Frame: 8-day follow-up after vaccination
8-day follow-up after vaccination
Occurrence, intensity and relationship of solicited general symptoms
Time Frame: 8-day follow-up after vaccination
8-day follow-up after vaccination
Incidence of unsolicited symptoms
Time Frame: During the 30-day follow-up after vaccination
During the 30-day follow-up after vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1992

Primary Completion (ACTUAL)

May 1, 1996

Study Completion (ACTUAL)

December 1, 1998

Study Registration Dates

First Submitted

June 11, 2008

First Submitted That Met QC Criteria

June 11, 2008

First Posted (ESTIMATE)

June 13, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 13, 2008

Last Update Submitted That Met QC Criteria

June 11, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 208129/004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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