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
  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:


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
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: 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 August 01, 2014