Immunogenicity & Reactogenicity of HBV-MPL Vaccine and Engerix™-B in Healthy Adults Following 2 Different Schedules
Status and phase
Completed
Phase 2
Conditions
Hepatitis B
Treatments
Biological: HBV-MPL vaccine
Biological: Engerix™-B
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
1
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Data sourced from clinicaltrials.gov
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