Last updated: 11/07/2018 12:57:47
Immunogenicity and safety of a novel adjuvanted HBV vaccine in healthy volunteers positive for the HLA-DQ2 genotype
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Phase III study to compare immunogenicity, safety and reactogenicity of GSK Biologicals’ novel adjuvanted hepatitis B vaccine adminstered intramuscularly, according to a 0, 6 month schedule, to Engerix™-B 20 mcg administered according to a 0,1,6 month schedule in healthy volunteers positive for the HLA-DQ2 genotype
Trial description: This study compares the immunogenicity and safety of the novel adjuvanted HBV vaccine and Engerix™-B administered to subjects who were positively identified as having the HLA-DQ2 genotype
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Anti-HBs antibody concentrations
Timeframe: At month 7
Secondary outcomes:
Occurrence, intensity and relationship to vaccination of solicited local and general signs and symptoms
Timeframe: During a 4 day follow-up period after each vaccination
Occurrence, intensity and relationship to vaccination of unsolicited symptoms
Timeframe: During a 30 day follow-up period after each vaccination
Occurrence, intensity and relationship to vaccination of serious adverse events (SAEs)
Timeframe: During the study period
Anti-HBs antibody concentrations
Timeframe: Day 0, Month 1, Month 6 and Month 7
Cell mediated immunity
Timeframe: At Months 0 and 7
Interventions:
Biological/vaccine: HBV-MPL vaccine 208129
Biological/vaccine: Engerix™-B
Enrollment:
230
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)
April 1999 to January 2000
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
15+ years
Accepts healthy volunteers
Yes
- A male or female ≥ 15 years of age at the time of the first vaccination.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after.
Inclusion and exclusion criteria
Inclusion criteria:
- A male or female ≥ 15 years of age at the time of the first vaccination.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Written informed consent obtained from the subject/ from the parents or guardians of the subject.
- Known to be seronegative for anti-HBs-antibodies, anti-HBc-antibodies and/or HBsAg.
- Positive for the HLA-DQ2 genotype as determined in the previous sero-HBV-069 prevalence study.
- If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination
Exclusion criteria:
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after.
- Previous vaccination against hepatitis B.
- History of non-response to previous hepatitis B vaccination.
- Known exposure to hepatitis B within 6 weeks.
- History of hepatitis B infection.
- Confirmed human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Acute disease at the time of enrollment.
- Hepatomegaly, right upper quadrant abdominal pain or tenderness.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration/ administration during the study period.
- Pregnant or lactating female
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2000-31-01
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
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