Last updated: 11/04/2018 00:33:49
Immunogenicity and reactogenicity of MPL adjuvanted recombinant hepatitis B- vaccine and Engerix™-B in adult non-responders
GSK study ID
208129/021
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:
Anti-HBs antibody concentrations
Timeframe: At month 7
Secondary outcomes:
Anti-HBs antibody concentrations
Timeframe: At months 2, 6, 7 and 12
Occurrence and intensity of solicited local symptoms
Timeframe: 4-day follow-up after vaccination
Occurrence, intensity and relationship of solicited general symptoms
Timeframe: 4-day follow-up after vaccination
Occurrence, intensity and relationship to vaccination of unsolicited symptoms
Timeframe: Within 30 days after vaccination
Incidence of serious AEs
Timeframe: Throughout the entire study up to and including 30 days after the last vaccination
Cell mediated immunity
Timeframe: At months 0, 2, 6, 7, 12
Interventions:
Biological/vaccine: Recombinant MPL- adjuvanted hepatitis B vaccine
Biological/vaccine: Engerix™-B
Enrollment:
116
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hepatitis B
Product
Hepatitis B Vaccine, Recombinant
Collaborators
Not applicable
Study date(s)
May 1997 to June 1998
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- Age: older than 18 years of age.
- Documented non-responders 2 to 5 months after having received 4 doses of a hepatitis B vaccine
- Positive at screening for anti-HBV antibodies
- Elevated serum liver enzymes.
Inclusion and exclusion 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
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
1998-30-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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