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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Hepatitis B

Treatments: Biological: HBV-MPL vaccine 208129; Biological: Engerix™-B

Study type: Interventional

Funder types: Industry

Identifiers

NCT00699231

208129/002

Details and patient eligibility

About

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

Full description

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

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 8 patient groups

Group A1

Active Comparator group

Description:

Non-responders to vaccination after at least 7 previous injections

Treatment:

Biological: Engerix™-B

Group A2

Experimental group

Description:

Non-responders to vaccination after at least 7 previous injections

Treatment:

Biological: HBV-MPL vaccine 208129

Group B1

Active Comparator group

Description:

Vaccine-responders requiring a booster dose

Treatment:

Biological: Engerix™-B

Group B2

Experimental group

Description:

Vaccine-responders requiring a booster dose

Treatment:

Biological: HBV-MPL vaccine 208129

Group C1

Active Comparator group

Description:

Volunteers participating in the hospital's vaccination program

Treatment:

Biological: Engerix™-B

Group C2

Experimental group

Description:

Volunteers participating in the hospital's vaccination program

Treatment:

Biological: HBV-MPL vaccine 208129

Group D1

Active Comparator group

Description:

Unvaccinated haemodialysis patients

Treatment:

Biological: Engerix™-B

Group D2

Experimental group

Description:

Unvaccinated haemodialysis patients

Treatment:

Biological: HBV-MPL vaccine 208129