Immunogenicity & Reactogenicity of HBV-MPL Vaccine and Engerix™-B in Healthy Adults Following 2 Different Schedules
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00697229
First received: June 11, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis B |
Biological: Engerix™-B Biological: HBV-MPL vaccine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | Study to Evaluate the Immunogenicity and Reactogenicity of GSK Biologicals' MPL-Adjuvanted Recombinant Hepatitis B Vaccine in Comparison With Those of Engerix™-B in Healthy Adult Volunteers Following 2 Different Schedules |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Anti-hepatitis B surface antigen (HBs) antibody concentrations [ Time Frame: One month after the full primary vaccination course and one month after the booster vaccination at 70 months ]
Secondary Outcome Measures:
- Anti-HBs antibody concentrations [ Time Frame: Months 1, 2, 3, 6, 12, 13, 42 ]
- Serious adverse experiences (SAE). [ Time Frame: Throughout the study period ]
- Occurrence and intensity of solicited local symptoms [ Time Frame: 8-day follow-up after vaccination ]
- Occurrence, intensity and relationship of solicited general symptoms [ Time Frame: 8-day follow-up after vaccination ]
- Incidence of unsolicited symptoms [ Time Frame: During the 30-day follow-up after vaccination ]
| Enrollment: | 99 |
| Study Start Date: | September 1992 |
| Study Completion Date: | December 1998 |
| Primary Completion Date: | May 1996 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group A
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
|
Biological: HBV-MPL vaccine
Intramuscular injection, 1 or 3 doses
|
|
Experimental: Group B
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
|
Biological: Engerix™-B
Intramuscular injection, 1 or 3 doses
Biological: HBV-MPL vaccine
Intramuscular injection, 1 or 3 doses
|
|
Experimental: Group C
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
|
Biological: Engerix™-B
Intramuscular injection, 1 or 3 doses
|
|
Experimental: Group D
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
|
Biological: Engerix™-B
Intramuscular injection, 1 or 3 doses
Biological: HBV-MPL vaccine
Intramuscular injection, 1 or 3 doses
|
|
Experimental: Group E
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
|
Biological: HBV-MPL vaccine
Intramuscular injection, 1 or 3 doses
|
|
Experimental: Group F
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
|
Biological: Engerix™-B
Intramuscular injection, 1 or 3 doses
Biological: HBV-MPL vaccine
Intramuscular injection, 1 or 3 doses
|
|
Experimental: Group G
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
|
Biological: Engerix™-B
Intramuscular injection, 1 or 3 doses
|
|
Experimental: Group H
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
|
Biological: Engerix™-B
Intramuscular injection, 1 or 3 doses
Biological: HBV-MPL vaccine
Intramuscular injection, 1 or 3 doses
|
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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Isabelle Harpigny, GSK |
| ClinicalTrials.gov Identifier: | NCT00697229 History of Changes |
| Other Study ID Numbers: | 208129/004 |
| Study First Received: | June 11, 2008 |
| Last Updated: | June 11, 2008 |
| Health Authority: | Belgium: Ministry of Social Affairs, Public Health and the Environment |
Keywords provided by GlaxoSmithKline:
|
Hepatitis B Engerix™-B Recombinant hepatitis B vaccine |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections |
ClinicalTrials.gov processed this record on May 19, 2013