Last updated: 11/04/2018 00:35:33
Immunogenicity and safety of an adjuvanted HBV vaccine compared to Engerix™-B, in a non-responder population ≥ 15y
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A study to compare the immunogenicity and safety of GSK Biologicals adjuvanted HBV vaccine to Engerix™-B, in a non-responder population ≥ 15 years of age, when administered intramuscularly, according to a 0, 1, 2, 12 month schedule
Trial description: Subjects who had not responded to previous hepatitis B vaccination were vaccinated with either the adjuvanted HBV-MPL vaccine or Engerix™-B vaccine according to a three-dose vaccination schedule (0, 1, 2 months) and boosted at Month 12 as per their group allocation. The immunogenicity and safety of the HBV-MPL vaccine were compared with the control vaccine, Engerix™-B.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:
Anti-HBs antibody concentrations
Timeframe: Months 1, 2 and 3
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 vaccination
Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms
Timeframe: During a 30 day follow-up period after vaccination
Occurrence, intensity and relationship to vaccination of serious adverse events (SAEs)
Timeframe: During the study period, up to and including 6 months post-vaccination
Anti-HBs antibody concentrations in all subjects
Timeframe: Months 1, 2, 3, 12 and 13
Interventions:
Enrollment:
145
Primary completion date:
2000-30-09
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Verstraeten T et al. (2008) Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 26(51):6630–6638.
Medical condition
Hepatitis B
Product
Hepatitis B Vaccine, Recombinant
Collaborators
Not applicable
Study date(s)
November 1999 to May 2001
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
15+ years
Accepts healthy volunteers
Yes
- At study entry:
- A male or female ≥ 15 years of age at the time of the first vaccination.
- 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:
- At study entry:
- 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.
- Documented non-response to previous hepatitis B vaccination within 6 months after having received a full vaccination course (i.e. ≥ 3 doses of a hepatitis B vaccine)
- 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. Before booster dose at month 12:
- Additional written informed consent covering the booster administration and blood samples at months 12 and 13 must be obtained from the subject.
- 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 and up to two months after the administration of the booster dose
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.
- 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/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)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
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
Study complete
Actual primary completion date
2000-30-09
Actual study completion date
2001-31-05
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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