Immunogenicity & Reactogenicity of HBV-MPL Vaccine and Engerix™-B in Healthy Adults Following 2 Different Schedules

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Completed
Phase 2

Conditions

Hepatitis B

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00697229
208129/004

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, immunogenicity and reactogenicity of MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in healthy adult volunteers following two different schedules: 0, 2 months and 0, 6 months

Full description

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

Enrollment

99 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Between 18 and 40 years old.
  • Written informed consent will have been obtained from the subjects.
  • Good physical condition as established by physical examination and history taking at the time of entry.
  • Female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry.

Exclusion criteria

  • Positive titres for anti hepatitis B antibodies.
  • Any vaccination against hepatitis B in the past.
  • Elevated serum liver enzymes.
  • History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
  • Axillary temperature > 37°C at the time of injection.
  • Any acute disease at the moment of entry.
  • Chronic alcohol consumption.
  • 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.
  • Administration of any other vaccine(s) or any immunoglobulin during the study period.
  • Simultaneous participation in any other clinical trial.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

99 participants in 8 patient groups

Group A
Experimental group
Description:
Subjects will receive HBV-MPL vaccine in the primary schedule 0, 2 months and will receive a booster dose of HBV-MPL vaccine at 70 months
Treatment:
Biological: HBV-MPL vaccine
Group B
Experimental group
Description:
Subjects will receive HBV-MPL vaccine in the primary schedule 0, 2 months and will receive a booster dose of Engerix™-B vaccine at 70 months
Treatment:
Biological: HBV-MPL vaccine
Biological: Engerix™-B
Group C
Experimental group
Description:
Subjects will receive Engerix™-B vaccine in the primary schedule 0, 2 months and will receive a booster dose of HBV-MPL vaccine at 70 months
Treatment:
Biological: Engerix™-B
Group D
Experimental group
Description:
Subjects will receive Engerix™-B vaccine in the primary schedule 0, 2 months and will receive a booster dose of Engerix™-B vaccine at 70 months
Treatment:
Biological: HBV-MPL vaccine
Biological: Engerix™-B
Group E
Experimental group
Description:
Subjects will receive HBV-MPL vaccine in the primary schedule 0, 6 months and will receive a booster dose of HBV-MPL vaccine at 70 months
Treatment:
Biological: HBV-MPL vaccine
Group F
Experimental group
Description:
Subjects will receive HBV-MPL vaccine in the primary schedule 0, 6 months and will receive a booster dose of Engerix™-B vaccine at 70 months
Treatment:
Biological: HBV-MPL vaccine
Biological: Engerix™-B
Group G
Experimental group
Description:
Subjects will receive Engerix™-B vaccine in the primary schedule 0, 6 months and will receive a booster dose of HBV-MPL vaccine at 70 months
Treatment:
Biological: Engerix™-B
Group H
Experimental group
Description:
Subjects will receive Engerix™-B vaccine in the primary schedule 0, 6 months and will receive a booster dose of Engerix™-B vaccine at 70 months
Treatment:
Biological: HBV-MPL vaccine
Biological: Engerix™-B

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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