Clinical trial NCT00697229: Immunogenicity & Reactogenicity of HBV-MPL Vaccine and Engerix™-B in Healthy Adults Following 2 Different Schedules
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis B
Keywords: Hepatitis B
Engerix™-B
Recombinant hepatitis B vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-06-13
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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

Detailed description: At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Eligibility 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.

Primary outcomes:
measure: Anti-hepatitis B surface antigen (HBs) antibody concentrations
timeFrame: One month after the full primary vaccination course and one month after the booster vaccination at 70 months
Secondary outcomes:
measure: Anti-HBs antibody concentrations
timeFrame: Months 1, 2, 3, 6, 12, 13, 42
measure: Serious adverse experiences (SAE).
timeFrame: Throughout the study period
measure: Occurrence and intensity of solicited local symptoms
timeFrame: 8-day follow-up after vaccination
measure: Occurrence, intensity and relationship of solicited general symptoms
timeFrame: 8-day follow-up after vaccination
measure: Incidence of unsolicited symptoms
timeFrame: During the 30-day follow-up after vaccination
Other outcomes:
Locations:
city: Wilrijk
country: Belgium
facility: GSK Clinical Trials Call Center
Study officials:
affiliation: GlaxoSmithKline
name: Clinical Trials
role: STUDY_DIRECTOR
References: