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Immunogenicity and Reactogenicity of MPL Adjuvanted Recombinant Hepatitis B- Vaccine and Engerix™-B in Adult Non-Responders

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00697931
First received: June 12, 2008
Last updated: June 13, 2008
Last verified: June 2008
History of Changes
  Purpose

The purpose of this study is to compare the immunogenicity and reactogenicity of the adjuvanted recombinant hepatitis B vaccine with that of Engerix™-B when both are injected according to a three dose schedule (0, 1, 6 months) in an adult non-responder population


Condition Intervention Phase
Hepatitis B
 Biological: Recombinant MPL- adjuvanted hepatitis B vaccine
Biological: Engerix™-B
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Study to Compare the Immunogenicity and Reactogenicity of GSK Biologicals; (Previously SmithKline Beecham Biologicals') MPL-Adjuvanted Recombinant Hepatitis B Vaccine With That of Engerix™-B in an Adult Non-Responder Population

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

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

Secondary Outcome Measures:
  • Anti-HBs antibody concentrations [ Time Frame: At months 2, 6, 7 and 12 ]
  • Occurrence and intensity of solicited local symptoms [ Time Frame: 4-day follow-up after vaccination ]
  • Occurrence, intensity and relationship of solicited general symptoms [ Time Frame: 4-day follow-up after vaccination ]
  • Occurrence, intensity and relationship to vaccination of unsolicited symptoms [ Time Frame: Within 30 days after vaccination ]
  • Incidence of serious AEs [ Time Frame: Throughout the entire study up to and including 30 days after the last vaccination ]
  • Cell mediated immunity [ Time Frame: At months 0, 2, 6, 7, 12 ]

Enrollment: 116
Study Start Date: May 1997
Study Completion Date: June 1998
Primary Completion Date: June 1998 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Biological: Recombinant MPL- adjuvanted hepatitis B vaccine
Intramuscular injection, 3 doses
Active Comparator: Group B Biological: Engerix™-B
Intramuscular injection, 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 and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age: older than 18 years of age.
  • Documented non-responders 2 to 5 months after having received 4 doses of a hepatitis B vaccine
  • 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 at screening for anti-HBV 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 an MPL containing vaccine.
  • Administration of immunoglobulins 6 months before 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: NCT00697931

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

No publications provided

Responsible Party: Isabelle Harpigny, GSK
ClinicalTrials.gov Identifier: NCT00697931     History of Changes
Other Study ID Numbers: 208129/021
Study First Received: June 12, 2008
Last Updated: June 13, 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
Adjuvant

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 May 19, 2013