Hepatitis B Clinical Trial
Official title:
Study to Compare the Immunogenicity and Reactogenicity of GSK Biologicals; (Previously SmithKline Beecham Biologicals') MPL-Adjuvanted Recombinant Hepatitis B Vaccine With That of Engerix™-B in an Adult Non-Responder Population
The purpose of this study is to compare the immunogenicity and reactogenicity of the adjuvanted recombinant hepatitis B vaccine with that of Engerix™-B when both are injected according to a three dose schedule (0, 1, 6 months) in an adult non-responder population
Status | Completed |
Enrollment | 116 |
Est. completion date | June 1998 |
Est. primary completion date | June 1998 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age: older than 18 years of age. - Documented non-responders 2 to 5 months after having received 4 doses of a hepatitis B vaccine - 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 at screening for anti-HBV 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 an MPL containing vaccine. - Administration of immunoglobulins 6 months before and during the whole study period - Vaccination one month before and one month after each dose of the study vaccine |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Belgium | GSK Clinical Trials Call Center | Leuven |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anti-HBs antibody concentrations | At month 7 | ||
Secondary | Anti-HBs antibody concentrations | At months 2, 6, 7 and 12 | ||
Secondary | Occurrence and intensity of solicited local symptoms | 4-day follow-up after vaccination | ||
Secondary | Occurrence, intensity and relationship of solicited general symptoms | 4-day follow-up after vaccination | ||
Secondary | Occurrence, intensity and relationship to vaccination of unsolicited symptoms | Within 30 days after vaccination | ||
Secondary | Incidence of serious AEs | Throughout the entire study up to and including 30 days after the last vaccination | ||
Secondary | Cell mediated immunity | At months 0, 2, 6, 7, 12 |
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