Safety and Immunogenicity of GSK Bio's Candidate HBV-MPL Vaccines Compared to Engerix™-B, in Healthy Adolescents

Study to Assess the Feasibility of GSK Bio's Candidate HBV / MPL Vaccines Following Different Schedules and Formulations and to Compare Their Safety and Immunogenicity to That of Engerix™-B in Healthy Adolescents Aged 11 to 15

In this study the safety and immunogenicity of 2 different formulations of the candidate HBV-MPL vaccine administered according to a 0, 6-month schedule were explored and compared to that of Engerix™-B in healthy adolescents aged 11 to 15

Study Overview

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

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): 200
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Mainz, Germany
    • GSK Clinical Trials Call Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 15 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age: between 11 and 15 years at the time of the first vaccination.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.
• Written informed consent obtained from the parents or guardians of the subject and from the subject himself/herself in all subjects 15 years of age.
• If the subject is female, she must be of non-childbearing potential, if of childbearing potential, she must be abstinent or have used an adequate contraceptive for one month prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series

Exclusion Criteria:

• Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
• Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination.
• Planned administration of a vaccine not foreseen by the study protocol during the period starting from one week before each dose of vaccine and ending 30 days after.
• Previous vaccination against hepatitis B virus.
• Previous vaccination with vaccine containing MPL.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Acute disease at the time of enrollment.
• Hepatomegaly, right upper quadrant abdominal pain or tenderness.
• Axillary temperature of ≥ 37.5° C.
• Administration of immunoglobulin and / or any blood product within the six months preceding the first dose of study vaccine or planned administration during the study period.
• Pregnant or lactating female.
• History of chronic disease deemed by the investigator to be relevant.
• Positive for anti-HBV antibodies at screening

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

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; HBV-MPL Formulation A at months 0 and 6	Biological: HBV-MPL vaccine Formulation A; Single dose (when extemporaneously co-administered with Engerix™-B) or 2-dose (when administered alone) intramuscular injection
Experimental: Group B; HBV-MPL Formulation B at months 0 and 6	Biological: HBV-MPL vaccine Formulation B; 2-dose intramuscular injection
Experimental: Group C; HBV-MPL Formulation A at month 0 and Engerix™-B at month 6	Biological: HBV-MPL vaccine Formulation A; Single dose (when extemporaneously co-administered with Engerix™-B) or 2-dose (when administered alone) intramuscular injection; Biological: Engerix™-B; Single dose (when extemporaneously co-administered with HBV-MPL) or 3-dose (when administered alone) intramuscular injection
Active Comparator: Group D; Engerix™-B at months 0, 1, 6	Biological: Engerix™-B; Single dose (when extemporaneously co-administered with HBV-MPL) or 3-dose (when administered alone) intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of Serious adverse experiences (SAE)	During the study period
Occurrence, intensity and relationship to vaccination of solicited local and general symptoms	During the 8-day follow-up period after vaccination
Occurrence, intensity and causal relationship of unsolicited adverse events	31-day follow-up period after vaccination

Secondary Outcome Measures

Outcome Measure	Time Frame
Anti-HBs antibody concentrations	At months 1, 2, 6, and 7
Cell mediated immunity	At months 1, 6, and 7

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: March 1, 1998
• Primary Completion (Actual): May 1, 1999

Study Registration Dates

• First Submitted: June 12, 2008
• First Submitted That Met QC Criteria: June 13, 2008
• First Posted (Estimate): June 16, 2008

Study Record Updates

• Last Update Posted (Estimate): June 16, 2008
• Last Update Submitted That Met QC Criteria: June 13, 2008
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Keywords: Hepatitis B; Adjuvant; 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; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 208129/028