Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine (2 Doses), and of Engerix™-B (3 Doses) in Healthy Adults

Hepatitis B Clinical Trial

Official title:

Study to Evaluate the Immunogenicity and Safety of GSK Biologicals' Novel Adjuvanted Hepatitis B Vaccine Administered According to a 0, 6 Month Schedule and of Engerix™-B Administered According to a 0, 1, 6 Month Schedule in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00697853
• Other study ID #: 208129/030
• Status: Completed
• Phase: Phase 2
• First received: June 12, 2008
• Last updated: June 13, 2008
• Start date: November 1998

Study information

• Verified date: June 2008
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study is undertaken to assess the immune response and safety profile of 4 lots of the novel adjuvanted hepatitis B vaccine that were formulated following different processes, with Engerix™-B as the control vaccine

Description:

This is an open, randomized study with five groups, but the four groups receiving HBV-MPL candidate vaccine are double-blinded.

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: 200
• Est. primary completion date: July 1999
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 50 Years

Eligibility

Inclusion Criteria:

• A male or female between 15 and 50 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 and/or from the parents or guardians of the subject.

• 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 vaccination 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.

• Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination.

• 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 significant and persisting hematological, hepatic, renal, cardiac or respiratory disease.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, including 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.

• Oral temperature of =37.5°C (99.5°F).

• 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.

• History of chronic alcohol consumption and/or intravenous drug abuse

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

Locations

Country	Name	City	State
Belgium	GSK Clinical Trial Call Center	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-HBs antibody concentrations		At month 7
Secondary	Anti-HBs antibody concentrations		At months 1, 2 and 6
Secondary	Occurrence and intensity of solicited local and general symptoms		4-day follow-up period after each vaccination
Secondary	Occurrence, intensity and relationship to vaccination of unsolicited symptoms		30-day follow-up period after each vaccination
Secondary	Occurrence, intensity and relationship to vaccination of SAEs		Throughout the entire study