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

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ClinicalTrials.gov Identifier: NCT00698555
Recruitment Status : Completed
First Posted : June 17, 2008
Last Update Posted : June 17, 2008
Sponsor:
Information provided by:
GlaxoSmithKline

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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

Condition or disease Intervention/treatment Phase
Hepatitis B Biological: HBV-MPL vaccine Biological: Engerix™-B Phase 2

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 163 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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
Study Start Date : March 1997
Actual Primary Completion Date : May 1998

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U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Group A Biological: HBV-MPL vaccine
5 different formulations, 2-dose intramuscular injection
Experimental: Group B Biological: HBV-MPL vaccine
5 different formulations, 2-dose intramuscular injection
Experimental: Group C Biological: HBV-MPL vaccine
5 different formulations, 2-dose intramuscular injection
Experimental: Group D Biological: HBV-MPL vaccine
5 different formulations, 2-dose intramuscular injection
Experimental: Group E Biological: HBV-MPL vaccine
5 different formulations, 2-dose intramuscular injection
Active Comparator: Group F Biological: Engerix™-B
3-dose intramuscular injection


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Anti-HBs antibody concentrations [ Time Frame: Month 7 ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00698555


Locations
Belgium
GSK Clinical Trials Call Center
Gent, Belgium
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: Clinical Trials GlaxoSmithKline
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Isabelle Harpigny, GSK
ClinicalTrials.gov Identifier: NCT00698555     History of Changes
Other Study ID Numbers: 208129/025
First Posted: June 17, 2008    Key Record Dates
Last Update Posted: June 17, 2008
Last Verified: June 2008

Keywords provided by GlaxoSmithKline:
Hepatitis B
HBV-MPL
Recombinant hepatitis B vaccine

Additional relevant MeSH terms:
Hepatitis
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
 Virus Diseases
Hepatitis, Viral, Human
Vaccines
Immunologic Factors
Physiological Effects of Drugs