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

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00697749
• Other study ID #: 208129/034
• Status: Completed
• Phase: Phase 3
• First received: June 11, 2008
• Last updated: September 15, 2016
• Start date: April 1999
• Est. completion date: January 2000

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: January 2000
• Est. primary completion date: January 2000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Biological:
• HBV-MPL vaccine 208129
2-dose intramuscular injection
• Engerix™-B
3-dose intramuscular injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

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

External Links

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