Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Healthy Volunteers Positive for the HLA-DQ2 Genotype

Phase III Study to Compare Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Novel Adjuvanted Hepatitis B Vaccine Adminstered Intramuscularly, According to a 0, 6 Month Schedule, to Engerix™-B 20 mcg Administered According to a 0,1,6 Month Schedule in Healthy Volunteers Positive for the HLA-DQ2 Genotype

This study compares the immunogenicity and safety of the novel adjuvanted HBV vaccine and Engerix™-B administered to subjects who were positively identified as having the HLA-DQ2 genotype

Study Overview

• Status: Completed
• Conditions: Hepatitis B
• Intervention / Treatment: Biological: Engerix™-B; Biological: HBV-MPL vaccine 208129

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): 230
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A male or female ≥ 15 years of age 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 subject/ from the parents or guardians of the subject.
• Known to be seronegative for anti-HBs-antibodies, anti-HBc-antibodies and/or HBsAg.
• Positive for the HLA-DQ2 genotype as determined in the previous sero-HBV-069 prevalence study.
• If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination

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.
• Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after.
• Previous vaccination against hepatitis B.
• History of non-response to previous hepatitis B vaccination.
• Known exposure to hepatitis B within 6 weeks.
• History of hepatitis B infection.
• Confirmed human immunodeficiency virus (HIV) infection.
• A family history of congenital or hereditary immunodeficiency.
• 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.
• Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration/ administration during the study period.
• Pregnant or lactating female

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A	Biological: HBV-MPL vaccine 208129; 2-dose intramuscular injection
Active Comparator: Group B	Biological: Engerix™-B; 3-dose intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Anti-HBs antibody concentrations	At month 7

Secondary Outcome Measures

Outcome Measure	Time Frame
Occurrence, intensity and relationship to vaccination of solicited local and general signs and symptoms	During a 4 day follow-up period after each vaccination
Occurrence, intensity and relationship to vaccination of unsolicited symptoms	During a 30 day follow-up period after each vaccination
Occurrence, intensity and relationship to vaccination of serious adverse events (SAEs)	During the study period
Anti-HBs antibody concentrations	Day 0, Month 1, Month 6 and Month 7
Cell mediated immunity	At Months 0 and 7

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: April 1, 1999
• Primary Completion (Actual): January 1, 2000
• Study Completion (Actual): January 1, 2000

Study Registration Dates

• First Submitted: June 11, 2008
• First Submitted That Met QC Criteria: June 13, 2008
• First Posted (Estimate): June 16, 2008

Study Record Updates

• Last Update Posted (Estimate): September 16, 2016
• Last Update Submitted That Met QC Criteria: September 15, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Hepatitis B; Recombinant hepatitis B vaccine; Adjuvanted hepatitis B vaccine
• 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: 208129/034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Informed Consent Form
   Information identifier: 208129/034
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Statistical Analysis Plan
   Information identifier: 208129/034
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Dataset Specification
   Information identifier: 208129/034
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Individual Participant Data Set
   Information identifier: 208129/034
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Study Protocol
   Information identifier: 208129/034
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Clinical Study Report
   Information identifier: 208129/034
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register