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
  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:


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
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: 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 July 22, 2014