Last updated: 11/04/2018 00:34:07
Comparing immunogenicity and safety of different formulations of HBV-MPL vaccine with Engerix™-B in adults aged 18-40 y
GSK study ID
208129/025
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Study comparing the immunogenicity and reactogenicity of different formulations of GSK Bio’s HBV-MPL vaccine injected as a 0, 6 months schedule with that of Engerix™-B injected as a 0, 1, 6 months schedule in healthy adults aged 18-40 years
Trial description: This study will evaluate the immunogenicity and safety of different formulations of the candidate HBV-MPL vaccine administered according to a 2-dose schedule and compare it to that of Engerix™-B administered according to a 3-dose schedule in order to determine the optimal dose of each component of the candidate HBV-MPL vaccine when administered at 0 and 6 months
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Anti-HBs antibody concentrations
Timeframe: Month 7
Secondary outcomes:
Anti-HBs antibody concentrations
Timeframe: Month 1, 2, 6 and 12
Cell mediated immunity
Timeframe: Month 1, 2, 6, 7 and 12
Occurrence and intensity and relationship to vaccination of solicited local and general symptoms
Timeframe: 4-day follow-up after vaccination
Occurrence and intensity and relationship to vaccination of unsolicited symptoms
Timeframe: 31-day follow-up after vaccination
Incidence of SAE
Timeframe: Throughout the study period
Interventions:
Biological/vaccine: HBV-MPL vaccine
Biological/vaccine: Engerix™-B
Enrollment:
163
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)
March 1997 to May 1998
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 40 Years
Accepts healthy volunteers
Yes
- Age: between 18 and 40 years old.
- Good physical condition as established by clinical examination and history taking at the time of entry.
- Positive titres at screening for anti-hepatitis antibodies.
- Elevated serum liver enzymes
Inclusion and exclusion criteria
Inclusion criteria:
- Age: between 18 and 40 years old.
- 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 titres at screening for anti-hepatitis 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 a hepatitis B vaccine.
- Previous vaccination with an MPL containing vaccine.
- Administration of immunoglobulins in the past 6 months 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
1998-31-05
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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