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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00699231
Recruitment Status : Completed
First Posted : June 17, 2008
Last Update Posted : June 17, 2008
Sponsor:
Information provided by:
GlaxoSmithKline

Brief Summary:
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 or disease Intervention/treatment Phase
Hepatitis B Biological: HBV-MPL vaccine 208129 Biological: Engerix™-B Phase 1

Detailed Description:
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : February 1992
Actual Primary Completion Date : December 1992
Actual Study Completion Date : December 1992

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00699231


Locations
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Belgium
GSK Clinical Trials Call Center
Brussels, Belgium
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: Clinical Trials GlaxoSmithKline
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Responsible Party: Isabelle Harpigny, GSK
ClinicalTrials.gov Identifier: NCT00699231    
Other Study ID Numbers: 208129/002
First Posted: June 17, 2008    Key Record Dates
Last Update Posted: June 17, 2008
Last Verified: June 2008
Keywords provided by GlaxoSmithKline:
Hepatitis B
Engerix™-B
Recombinant hepatitis B vaccine
Adjuvant
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections