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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00698555
First received: June 13, 2008
Last updated: June 16, 2008
Last verified: June 2008
  Purpose

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 Intervention Phase
Hepatitis B
Biological: HBV-MPL vaccine
Biological: Engerix™-B
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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

Secondary Outcome Measures:
  • Anti-HBs antibody concentrations [ Time Frame: Month 1, 2, 6 and 12 ]
  • Cell mediated immunity [ Time Frame: Month 1, 2, 6, 7 and 12 ]
  • Occurrence and intensity and relationship to vaccination of solicited local and general symptoms [ Time Frame: 4-day follow-up after vaccination ]
  • Occurrence and intensity and relationship to vaccination of unsolicited symptoms [ Time Frame: 31-day follow-up after vaccination ]
  • Incidence of SAE [ Time Frame: Throughout the study period ]

Enrollment: 163
Study Start Date: March 1997
Primary Completion Date: May 1998 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698555

Locations
Belgium
GSK Clinical Trials Call Center
Gent, Belgium
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Isabelle Harpigny, GSK
ClinicalTrials.gov Identifier: NCT00698555     History of Changes
Other Study ID Numbers: 208129/025
Study First Received: June 13, 2008
Last Updated: June 16, 2008
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on April 22, 2014