Immunogenicity and Reactogenicity of MPL Adjuvanted Recombinant Hepatitis B- Vaccine and Engerix™-B in Adult Non-Responders

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Hepatitis B

Treatments

Biological: Recombinant MPL- adjuvanted hepatitis B vaccine

Biological: Engerix™-B

Study type

Interventional

Funder types

Industry

Identifiers

NCT00697931

208129/021

Details and patient eligibility

About

The purpose of this study is to compare the immunogenicity and reactogenicity of the adjuvanted recombinant hepatitis B vaccine with that of Engerix™-B when both are injected according to a three dose schedule (0, 1, 6 months) in an adult non-responder population

Full description

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

Enrollment

116 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age: older than 18 years of age.
Documented non-responders 2 to 5 months after having received 4 doses of a hepatitis B vaccine
Good physical condition as established by clinical examination and history taking at the time of entry.
Female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period.
Written informed consent obtained from the subjects

Exclusion criteria

Positive at screening for anti-HBV antibodies
Elevated serum liver enzymes.
History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
Any acute disease at the moment of entry.
Chronic alcohol consumption.
Hepatomegaly, right upper quadrant abdominal pain or tenderness.
Any chronic drug treatment, including any treatment with immunosuppressive drugs, which in the investigator's opinion, precludes inclusion into the study.
History of allergic disease likely to be stimulated by any component of the vaccine.
Simultaneous participation in any other clinical trial.
Previous vaccination with an MPL containing vaccine.
Administration of immunoglobulins 6 months before and during the whole study period
Vaccination one month before and one month after each dose of the study vaccine