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Evaluation of Immunogenicity, Reactogenicity and Safety of HBV-MPL Vaccine vs Engerix™-B, in Haemodialysis Patients

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00699231
First received: June 13, 2008
Last updated: June 16, 2008
Last verified: June 2008
History of Changes
  Purpose

This trial is designed to evaluate the immunogenicity, reactogenicity and safety of an MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in haemodialysis patients with or without previous vaccination against hepatitis B


Condition Intervention Phase
Hepatitis B
 Biological: HBV-MPL vaccine 208129
Biological: Engerix™-B
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Study to Evaluate the Immunogenicity, Reactogenicity and Safety of GSK Biologicals' (Previously SmithKline Beecham Biologicals') MPL-Adjuvanted Recombinant Hepatitis B Vaccine Versus Engerix™-B, in Haemodialysis Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence and intensity of solicited local and general symptoms [ Time Frame: 4-day follow-up period after each vaccination ]
  • Occurrence of unsolicited adverse events [ Time Frame: During the course of the study ]
  • Occurrence of serious adverse events [ Time Frame: During the course of the study ]
  • Anti-HBs antibody concentrations [ Time Frame: Pre, Day 0, Day 30, Day 60, Day 90, Day 120, D180, D210 depending on group allocation ]

Enrollment: 30
Study Start Date: February 1992
Study Completion Date: December 1992
Primary Completion Date: December 1992 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A1
Non-responders to vaccination after at least 7 previous injections
 Biological: Engerix™-B
IM injection
Experimental: Group A2
Non-responders to vaccination after at least 7 previous injections
 Biological: HBV-MPL vaccine 208129
IM injection
Active Comparator: Group B1
Vaccine-responders requiring a booster dose
 Biological: Engerix™-B
IM injection
Experimental: Group B2
Vaccine-responders requiring a booster dose
 Biological: HBV-MPL vaccine 208129
IM injection
Active Comparator: Group C1
Volunteers participating in the hospital's vaccination program
 Biological: Engerix™-B
IM injection
Experimental: Group C2
Volunteers participating in the hospital's vaccination program
 Biological: HBV-MPL vaccine 208129
IM injection
Active Comparator: Group D1
Unvaccinated haemodialysis patients
 Biological: Engerix™-B
IM injection
Experimental: Group D2
Unvaccinated haemodialysis patients
 Biological: HBV-MPL vaccine 208129
IM 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 and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Dialysis patients
  • A medical examination including physical examination and medical history as well as serological screening established acceptability for enrollment into the study.
  • Age: from 18 years onwards
  • Seronegative for anti- hepatitis antibodies

Exclusion Criteria:

  • History of persistent hepatic, cardiac or respiratory disease
  • Any acute disease at the moment of entry into the study
  • Chronic alcohol consumption
  • Hepatomegaly, right upper quadrant pain or tenderness
  • Any treatment with coticosteroids or immunomodulating drugs
  • Known hypersensitivity to any component of the vaccine
  • Simultaneous participation in any other clinical trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00699231

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

No publications provided

Responsible Party: Isabelle Harpigny, GSK
ClinicalTrials.gov Identifier: NCT00699231     History of Changes
Other Study ID Numbers: 208129/002
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
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