Comparing Immunogenicity and Safety of Different Formulations of HBV-MPL Vaccine With Engerix™-B in Adults Aged 19-40 y

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Hepatitis B

Treatments: Biological: Engerix™-B; Biological: HBV-MPL vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00698906

208129/026

Details and patient eligibility

About

This study will evaluate the immunogenicity and safety of different formulations of the HBV-MPL vaccine administered according to a 2-dose schedule and compare it to that of Engerix™-B administered according to a 3-dose schedule in order to determine the optimal dose of each component of the candidate HBV-MPL vaccine when administered at 0 and 6 months

Full description

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

Enrollment: 160 patients

Sex: All

Ages: 19 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age: between 19 and 40 years old.
• 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 titres at screening for anti-hepatitis 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 a hepatitis B vaccine.
• Previous vaccination with an MPL containing vaccine.
• Administration of immunoglobulins in the past 3 months and during the whole study period
• Vaccination one month before and one month after each dose of the study vaccine

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

160 participants in 6 patient groups

Group A

Experimental group

Treatment:

Biological: HBV-MPL vaccine

Group B

Experimental group

Treatment:

Biological: HBV-MPL vaccine

Group C

Experimental group

Treatment:

Biological: HBV-MPL vaccine

Group D

Experimental group

Treatment:

Biological: HBV-MPL vaccine

Group E

Experimental group

Treatment:

Biological: HBV-MPL vaccine

Group F

Active Comparator group

Treatment:

Biological: Engerix™-B