Comparison of Immuno, Reacto and Safety of Recombinant Hepatitis B Vaccine With or Without MPL in Healthy Older Adults

Study to Compare the Immunogenicity, Safety and Reactogenicity of GSK Biologicals' (Previously SmithKline Beecham Biologicals') Recombinant Hepatitis B Vaccines With and Without Adjuvant in Healthy Older Adult Volunteers

In the present study the immunogenicity, reactogenicity and safety of recombinant hepatitis B vaccines with and without MPL will be evaluated in older healthy subjects

Study Overview

• Status: Completed
• Conditions: Hepatitis B
• Intervention / Treatment: Biological: Engerix™-B; Biological: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL

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): 362
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Wien, Austria
    • GSK Clinical Trials Call Center
• Belgium
  • Gent, Belgium
    • GSK Clinical Trials Call Center
• Denmark
  • Hvidovre, Denmark
    • GSK Clinical Trials Call Center
• Iceland
  • Reykjavik, Iceland
    • GSK Clinical Trials Call Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male or female subjects between 50 and 70 years old.
• Written informed consent will have been obtained from the subjects.
• Good physical condition as established by physical examination and history taking at the time of entry

Exclusion Criteria:

• Positive titres for anti hepatitis antibodies
• Any vaccination against hepatitis B in the past.
• Any previous administration of MPL
• Elevated serum liver enzymes at two subsequent determinations 14 days apart.
• History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
• Axillary temperature > 37.5°C at the time of injection.
• Any acute disease at the moment of entry.
• Chronic alcohol consumption.
• Any treatment with immunosuppressive or immunostimulant therapy.
• Any chronic drug treatment, 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.
• Administration of any other vaccine(s) or any immunoglobulin during the study period.
• Simultaneous participation in any other clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A	Biological: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL; Intramuscular injection, 3 doses
Experimental: Group B	Biological: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL; Intramuscular injection, 3 doses
Experimental: Group C	Biological: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL; Intramuscular injection, 3 doses
Experimental: Group E	Biological: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL; Intramuscular injection, 3 doses
Active Comparator: Group D	Biological: Engerix™-B; Intramuscular injection, 3 doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Anti-hepatitis B surface antigen (HBs) antibody concentrations	At M2 and M7

Secondary Outcome Measures

Outcome Measure	Time Frame
Anti-pre-S1 antibody concentrations	Screening, Months 1, 2, 3, 6, 7, 8 and 12, depending on group allocation
Anti-HBs antibody concentrations	Screening, Months 1, 2, 3, 6, 7, 8 and 12
Occurrence and intensity of local and general solicited symptoms	4-day after vaccination
Cell mediated immunity	Month 0, Month 2 and month 7
Occurrence of unsolicited adverse events	30 days after vaccination
Occurrence of serious adverse events	During the study period and 30 days after last vaccine dose

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: January 1, 1994
• Primary Completion (Actual): November 1, 1995
• Study Completion (Actual): November 1, 1995

Study Registration Dates

• First Submitted: June 11, 2008
• First Submitted That Met QC Criteria: June 11, 2008
• First Posted (Estimate): June 13, 2008

Study Record Updates

• Last Update Posted (Estimate): June 13, 2008
• Last Update Submitted That Met QC Criteria: June 11, 2008
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Keywords: Hepatitis B; Recombinant Hepatitis B vaccine; Engerix™-B
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis B; Hepatitis; Hepatitis A
• Other Study ID Numbers: 208129/009