Hepatitis BPhase 3NCT00698061
Immunogenicity and Safety of an Adjuvanted HBV Vaccine Compared to Engerix™-B, in a Non-responder Population ≥ 15y
A Phase 3 study testing HBV-MPL vaccine 208129 and Engerix™-B in people with Hepatitis B, run by GlaxoSmithKline.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- HBV-MPL vaccine 208129 and Engerix™-B
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- No sites listed yet
- Study dates
- Nov 1999to May 2001
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
About this study
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
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.
Read the detailed description
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham.
- Conditions
- Hepatitis B
- Being tested
- HBV-MPL vaccine 208129, Engerix™-B
- Keywords
- Hepatitis B, Adjuvanted vaccine
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBV-MPL vaccine 208129Biological
3-dose primary vaccination and booster vaccination by intramuscular injection
Engerix™-BBiological
3-dose primary vaccination and booster vaccination by intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Biological: HBV-MPL vaccine 208129 |
| Group B | Active comparator | Not described Receives: Biological: Engerix™-B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-HBs antibody concentrations
Measured: Months 1, 2 and 3
Secondary outcomes (4)
Occurrence, intensity and relationship to vaccination of solicited local and general signs and symptoms
Measured: During a 4 day follow-up period after vaccination
Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms
Measured: During a 30 day follow-up period after vaccination
Occurrence, intensity and relationship to vaccination of serious adverse events (SAEs)
Measured: During the study period, up to and including 6 months post-vaccination
Anti-HBs antibody concentrations in all subjects
Measured: Months 1, 2, 3, 12 and 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2008 (estimated)
- Study startNov 1999
- Primary completionSep 2000
- Study completionMay 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00698061
- Sponsor's protocol ID
- 208129/033
- Other IDs
- 208129/038
- Status last verified
- May 2017
- First submitted
- 11 Jun 2008
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008 Dec 2;26(51):6630-8. doi: 10.1016/j.vaccine.2008.09.049.
PubMed 18845199
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00698061
- Acronym / sponsor ID
- 208129/033
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B, Adjuvanted vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 1999
- Primary completion
- Sep 2000 (actual)
- Study completion
- May 2001 (actual)
- First posted
- 16 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: HBV-MPL vaccine 208129 |
| Group B | Active comparator | Biological: Engerix™-B |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBV-MPL vaccine 2081293-dose primary vaccination and booster vaccination by intramuscular injection | Biological | Group A |
| Engerix™-B3-dose primary vaccination and booster vaccination by intramuscular injection | Biological | Group B |
Primary outcome
Anti-HBs antibody concentrations
Time frame: Months 1, 2 and 3
4 secondary outcomes
Occurrence, intensity and relationship to vaccination of solicited local and general signs and symptoms
Time frame: During a 4 day follow-up period after vaccination
Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms
Time frame: During a 30 day follow-up period after vaccination
Occurrence, intensity and relationship to vaccination of serious adverse events (SAEs)
Time frame: During the study period, up to and including 6 months post-vaccination
Anti-HBs antibody concentrations in all subjects
Time frame: Months 1, 2, 3, 12 and 13
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Background: PubMed 18845199Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008 Dec 2;26(51):6630-8. doi: 10.1016/j.vaccine.2008.09.049.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HBV-MPL vaccine 208129 and Engerix™-B in people with Hepatitis B, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-HBs antibody concentrations (time frame: Months 1, 2 and 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00698061, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017; AzTrials last refreshed its copy on 8 Nov 2026.