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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 29, 2014