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Comparing Immunogenicity and Safety of Different Formulations of HBV-MPL Vaccine With Engerix™-B in Adults Aged 18-40 y
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00698555
First received: June 13, 2008
Last updated: June 16, 2008
Last verified: June 2008
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Purpose
This study will evaluate the immunogenicity and safety of different formulations of the candidate 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
| Condition | Intervention | Phase |
|---|---|---|
| Hepatitis B | Biological: HBV-MPL vaccine Biological: Engerix™-B | Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Anti-HBs antibody concentrations [ Time Frame: Month 7 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 163 |
| Study Start Date: | March 1997 |
| Primary Completion Date: | May 1998 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Detailed Description:
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00698555
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698555
Locations
| Belgium | |
| GSK Clinical Trials Call Center | |
| Gent, Belgium | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | Isabelle Harpigny, GSK |
| ClinicalTrials.gov Identifier: | NCT00698555 History of Changes |
| Other Study ID Numbers: |
208129/025 |
| Study First Received: | June 13, 2008 |
| Last Updated: | June 16, 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 |
ClinicalTrials.gov processed this record on August 23, 2017