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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00699231

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 I

MedlinePlus related topics: Dialysis Hepatitis Hepatitis B Kidney Failure

Drug Information available for: Hepatitis B Vaccines Recombinant hepatitis B vaccine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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

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
Group A1: Active Comparator Non-responders to vaccination after at least 7 previous injections	Biological: Engerix™-B IM injection
Group A2: Experimental Non-responders to vaccination after at least 7 previous injections	Biological: HBV-MPL vaccine 208129 IM injection
Group B1: Active Comparator Vaccine-responders requiring a booster dose	Biological: Engerix™-B IM injection
Group B2: Experimental Vaccine-responders requiring a booster dose	Biological: HBV-MPL vaccine 208129 IM injection
Group C1: Active Comparator Volunteers participating in the hospital's vaccination program	Biological: Engerix™-B IM injection
Group C2: Experimental Volunteers participating in the hospital's vaccination program	Biological: HBV-MPL vaccine 208129 IM injection
Group D1: Active Comparator Unvaccinated haemodialysis patients	Biological: Engerix™-B IM injection
Group D2: Experimental 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

Responsible Party:	GSK ( Isabelle Harpigny )
Study ID Numbers:	208129/002
Study First Received:	June 13, 2008
Last Updated:	June 16, 2008
ClinicalTrials.gov Identifier:	NCT00699231
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

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases

Hepatitis B
Hepatitis, Viral, Human
DNA Virus Infections

Additional relevant MeSH terms:

Hepadnaviridae Infections

ClinicalTrials.gov processed this record on January 16, 2009