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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00697229
First received: June 11, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ]

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

Enrollment: 99
Study Start Date: September 1992
Study Completion Date: December 1998
Primary Completion Date: May 1996 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Engerix™-B
Intramuscular injection, 1 or 3 doses
Biological: HBV-MPL vaccine
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: Engerix™-B
Intramuscular injection, 1 or 3 doses
Biological: HBV-MPL vaccine
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: Engerix™-B
Intramuscular injection, 1 or 3 doses
Biological: HBV-MPL vaccine
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: Engerix™-B
Intramuscular injection, 1 or 3 doses
Biological: HBV-MPL vaccine
Intramuscular injection, 1 or 3 doses

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:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00697229

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

No publications provided

Responsible Party: Isabelle Harpigny, GSK
ClinicalTrials.gov Identifier: NCT00697229     History of Changes
Other Study ID Numbers: 208129/004
Study First Received: June 11, 2008
Last Updated: June 11, 2008
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by GlaxoSmithKline:
Hepatitis B
Engerix™-B
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 17, 2014