Immunogenicity and Reactogenicity of MPL Adjuvanted Recombinant Hepatitis B- Vaccine and Engerix™-B in Adult Non-Responders

Phase 3

Completed

• Conditions: Hepatitis B
• Interventions: Biological: Recombinant MPL- adjuvanted hepatitis B vaccine; Biological: Engerix™-B

• Registration Number: NCT00697931
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The purpose of this study is to compare the immunogenicity and reactogenicity of the adjuvanted recombinant hepatitis B vaccine with that of Engerix™-B when both are injected according to a three dose schedule (0, 1, 6 months) in an adult non-responder population

Detailed Description

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

Study Timeline

• Study Start: 1997-05
• Primary Completion: 1998-06
• Study Completion: 1998-06
• Status Verified: 2008-06
• Study First Submitted: 2008-06-12
• Study First Submitted QC: 2008-06-13
• Last Update Submitted: 2008-06-13
• Study First Posted: 2008-06-16
• Last Update Posted: 2008-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• Age: older than 18 years of age.
• Documented non-responders 2 to 5 months after having received 4 doses of a hepatitis B vaccine
• Good physical condition as established by clinical examination and history taking at the time of entry.
• Female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period.
• Written informed consent obtained from the subjects

Exclusion Criteria

• Positive at screening for anti-HBV antibodies
• Elevated serum liver enzymes.
• History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
• Any acute disease at the moment of entry.
• Chronic alcohol consumption.
• Hepatomegaly, right upper quadrant abdominal pain or tenderness.
• Any chronic drug treatment, including any treatment with immunosuppressive drugs, which in the investigator's opinion, precludes inclusion into the study.
• History of allergic disease likely to be stimulated by any component of the vaccine.
• Simultaneous participation in any other clinical trial.
• Previous vaccination with an MPL containing vaccine.
• Administration of immunoglobulins 6 months before and during the whole study period
• Vaccination one month before and one month after each dose of the study vaccine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Recombinant MPL- adjuvanted hepatitis B vaccine	-
Group B	Engerix™-B	-

Primary Outcome Measures

Name	Time	Method
Anti-HBs antibody concentrations	At month 7

Secondary Outcome Measures

Name	Time	Method
Anti-HBs antibody concentrations	At months 2, 6, 7 and 12
Occurrence and intensity of solicited local symptoms	4-day follow-up after vaccination
Occurrence, intensity and relationship of solicited general symptoms	4-day follow-up after vaccination
Occurrence, intensity and relationship to vaccination of unsolicited symptoms	Within 30 days after vaccination
Incidence of serious AEs	Throughout the entire study up to and including 30 days after the last vaccination
Cell mediated immunity	At months 0, 2, 6, 7, 12

Trial Locations

Locations (1)

GSK Clinical Trials Call Center; 🇧🇪 Leuven, Belgium