Comparing Immunogenicity and Safety of Different Formulations of HBV-MPL Vaccine With Engerix™-B in Adults Aged 19-40 y

Study Comparing the Immunogenicity and Reactogenicity of Different Formulations of GSK Bio's HBV-MPL Vaccine Injected as a 0, 6 Months Schedule With That of Engerix™-B Injected as a 0, 1, 6 Months Schedule in Healthy Adults Aged 19-40 Years

This study will evaluate the immunogenicity and safety of different formulations of the HBV-MPL vaccine administered according to a 2-dose schedule and compare it to that of Engerix™-B administered according to a 3-dose schedule in order to determine the optimal dose of each component of the candidate HBV-MPL vaccine when administered at 0 and 6 months

Study Overview

• Status: Completed
• Conditions: Hepatitis B
• Intervention / Treatment: Biological: Engerix™-B; Biological: HBV-MPL vaccine

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Wien, Austria
    • GSK Clinical Trials Call Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age: between 19 and 40 years old.
• 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 titres at screening for anti-hepatitis 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 a hepatitis B vaccine.
• Previous vaccination with an MPL containing vaccine.
• Administration of immunoglobulins in the past 3 months and during the whole study period
• Vaccination one month before and one month after each dose of the study vaccine

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A	Biological: HBV-MPL vaccine; 5 different formulations, 2-dose intramuscular injection
Experimental: Group B	Biological: HBV-MPL vaccine; 5 different formulations, 2-dose intramuscular injection
Experimental: Group C	Biological: HBV-MPL vaccine; 5 different formulations, 2-dose intramuscular injection
Experimental: Group D	Biological: HBV-MPL vaccine; 5 different formulations, 2-dose intramuscular injection
Experimental: Group E	Biological: HBV-MPL vaccine; 5 different formulations, 2-dose intramuscular injection
Active Comparator: Group F	Biological: Engerix™-B; 3-dose intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Anti-HBs antibody concentrations	Month 7

Secondary Outcome Measures

Outcome Measure	Time Frame
Anti-HBs antibody concentrations	Month 1, 2 and 6
Occurrence, intensity and relationship to vaccination of solicited local and general symptoms	4-day follow-up after vaccination
Occurrence, intensity and relationship to vaccination of unsolicited symptoms	31-day follow-up after vaccination
Incidence of serious adverse events	During the study period

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: June 1, 1997
• Primary Completion (Actual): February 1, 1998

Study Registration Dates

• First Submitted: June 13, 2008
• First Submitted That Met QC Criteria: June 16, 2008
• First Posted (Estimate): June 17, 2008

Study Record Updates

• Last Update Posted (Estimate): June 17, 2008
• Last Update Submitted That Met QC Criteria: June 16, 2008
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Keywords: Hepatitis B; HBV-MPL; Recombinant Hepatitis B vaccine
• Additional Relevant MeSH Terms: Digestive System Diseases; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis B; Hepatitis
• Other Study ID Numbers: 208129/026