Clinical trial NCT00697931: Immunogenicity and Reactogenicity of MPL Adjuvanted Recombinant Hepatitis B- Vaccine and Engerix™-B in Adult Non-Responders
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Keywords: Hepatitis B
Engerix™-B
Recombinant Hepatitis B vaccine
Adjuvant
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-06-16
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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

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:

* 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

Primary outcomes:
measure: Anti-HBs antibody concentrations
timeFrame: At month 7
Secondary outcomes:
measure: Anti-HBs antibody concentrations
timeFrame: At months 2, 6, 7 and 12
measure: Occurrence and intensity of solicited local symptoms
timeFrame: 4-day follow-up after vaccination
measure: Occurrence, intensity and relationship of solicited general symptoms
timeFrame: 4-day follow-up after vaccination
measure: Occurrence, intensity and relationship to vaccination of unsolicited symptoms
timeFrame: Within 30 days after vaccination
measure: Incidence of serious AEs
timeFrame: Throughout the entire study up to and including 30 days after the last vaccination
measure: Cell mediated immunity
timeFrame: At months 0, 2, 6, 7, 12
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: GSK Clinical Trials Call Center
Study officials:
affiliation: GlaxoSmithKline
name: Clinical Trials
role: STUDY_DIRECTOR
References: