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

Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00699231
• Other study ID #: 208129/002
• Status: Completed
• Phase: Phase 1
• First received: June 13, 2008
• Last updated: June 16, 2008
• Start date: February 1992
• Est. completion date: December 1992

Study information

• Verified date: June 2008
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 1992
• Est. primary completion date: December 1992
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Biological:
• HBV-MPL vaccine 208129
IM injection
• Engerix™-B
IM injection

Locations

Country	Name	City	State
Belgium	GSK Clinical Trials Call Center	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence and intensity of solicited local and general symptoms		4-day follow-up period after each vaccination
Primary	Occurrence of unsolicited adverse events		During the course of the study
Primary	Occurrence of serious adverse events		During the course of the study
Primary	Anti-HBs antibody concentrations		Pre, Day 0, Day 30, Day 60, Day 90, Day 120, D180, D210 depending on group allocation