Comparing Immunogenicity and Safety of Different Formulations of HBV-MPL Vaccine With Engerix™-B in Adults Aged 18-40 y
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ClinicalTrials.gov Identifier: NCT00698555 |
Recruitment Status
:
Completed
First Posted
: June 17, 2008
Last Update Posted
: June 17, 2008
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis B | Biological: HBV-MPL vaccine Biological: Engerix™-B | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 163 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Study Comparing the Immunogenicity and Reactogenicity of Different Formulations of GSK Bio's HBV-MPL Vaccine Injected as a 0, 6 Months Schedule With That of Engerix™-B Injected as a 0, 1, 6 Months Schedule in Healthy Adults Aged 18-40 Years |
Study Start Date : | March 1997 |
Actual Primary Completion Date : | May 1998 |
Arm | Intervention/treatment |
---|---|
Experimental: Group A |
Biological: HBV-MPL vaccine
5 different formulations, 2-dose intramuscular injection
|
Experimental: Group B |
Biological: HBV-MPL vaccine
5 different formulations, 2-dose intramuscular injection
|
Experimental: Group C |
Biological: HBV-MPL vaccine
5 different formulations, 2-dose intramuscular injection
|
Experimental: Group D |
Biological: HBV-MPL vaccine
5 different formulations, 2-dose intramuscular injection
|
Experimental: Group E |
Biological: HBV-MPL vaccine
5 different formulations, 2-dose intramuscular injection
|
Active Comparator: Group F |
Biological: Engerix™-B
3-dose intramuscular injection
|
- Anti-HBs antibody concentrations [ Time Frame: Month 7 ]
- Anti-HBs antibody concentrations [ Time Frame: Month 1, 2, 6 and 12 ]
- Cell mediated immunity [ Time Frame: Month 1, 2, 6, 7 and 12 ]
- Occurrence and intensity and relationship to vaccination of solicited local and general symptoms [ Time Frame: 4-day follow-up after vaccination ]
- Occurrence and intensity and relationship to vaccination of unsolicited symptoms [ Time Frame: 31-day follow-up after vaccination ]
- Incidence of SAE [ Time Frame: Throughout the study period ]

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Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age: between 18 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 6 months and during the whole study period
- Vaccination one month before and one month after each dose of the study vaccine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00698555
Belgium | |
GSK Clinical Trials Call Center | |
Gent, Belgium |
Study Director: | Clinical Trials | GlaxoSmithKline |
Responsible Party: | Isabelle Harpigny, GSK |
ClinicalTrials.gov Identifier: | NCT00698555 History of Changes |
Other Study ID Numbers: |
208129/025 |
First Posted: | June 17, 2008 Key Record Dates |
Last Update Posted: | June 17, 2008 |
Last Verified: | June 2008 |
Keywords provided by GlaxoSmithKline:
Hepatitis B HBV-MPL Recombinant hepatitis B vaccine |
Additional relevant MeSH terms:
Hepatitis Hepatitis B Liver Diseases Digestive System Diseases Hepadnaviridae Infections DNA Virus Infections |
Virus Diseases Hepatitis, Viral, Human Vaccines Immunologic Factors Physiological Effects of Drugs |