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: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 May 22, 2017