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

NCT00697749 | Completed Phase 3

• 1 other identifier: 208129/034
• Study Type: interventional
• Target: 230
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hepatitis B

Keywords

Recombinant hepatitis B vaccine; Adjuvanted hepatitis B vaccine; Hepatitis B

Outcome Measures

Primary Outcomes (1)

• Anti-HBs antibody concentrations

  At month 7

Secondary Outcomes (5)

• 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

Study Arms (2)

Group A

EXPERIMENTAL

Biological: HBV-MPL vaccine 208129

Group B

ACTIVE COMPARATOR

Biological: Engerix™-B

Interventions

HBV-MPL vaccine 208129 BIOLOGICAL

2-dose intramuscular injection

Group A

Engerix™-B BIOLOGICAL

3-dose intramuscular injection

Group B

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related 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.

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2008
• First Posted: June 16, 2008
• Study Start: April 1, 1999
• Primary Completion: January 1, 2000
• Study Completion: January 1, 2000
• Last Updated: September 16, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share