Hepatitis BPhase 3NCT00697931
Immunogenicity and Reactogenicity of MPL Adjuvanted Recombinant Hepatitis B- Vaccine and Engerix™-B in Adult Non-Responders
A Phase 3 study testing Recombinant MPL- adjuvanted hepatitis B vaccine and Engerix™-B in people with Hepatitis B, run by GlaxoSmithKline at 1 site in Belgium.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Recombinant MPL- adjuvanted hepatitis B vaccine and Engerix™-B
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteBelgium
- Study dates
- May 1997to Jun 1998
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
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
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
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
- Recombinant MPL- adjuvanted hepatitis B vaccine, Engerix™-B
- Keywords
- Hepatitis B, Engerix™-B, Recombinant Hepatitis B vaccine, Adjuvant
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant MPL- adjuvanted hepatitis B vaccineBiological
Intramuscular injection, 3 doses
Engerix™-BBiological
Intramuscular injection, 3 doses
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Biological: Recombinant MPL- adjuvanted hepatitis B vaccine |
| 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: At month 7
Secondary outcomes (6)
Anti-HBs antibody concentrations
Measured: At months 2, 6, 7 and 12
Occurrence and intensity of solicited local symptoms
Measured: 4-day follow-up after vaccination
Occurrence, intensity and relationship of solicited general symptoms
Measured: 4-day follow-up after vaccination
Occurrence, intensity and relationship to vaccination of unsolicited symptoms
Measured: Within 30 days after vaccination
Incidence of serious AEs
Measured: Throughout the entire study up to and including 30 days after the last vaccination
Cell mediated immunity
Measured: At months 0, 2, 6, 7, 12
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 startMay 1997
- Primary completionJun 1998
- Study completionJun 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00697931
- Sponsor's protocol ID
- 208129/021
- Status last verified
- Jun 2008
- First submitted
- 12 Jun 2008
- Last updated
- 16 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00697931
- Acronym / sponsor ID
- 208129/021
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B, Engerix™-B, Recombinant Hepatitis B vaccine, Adjuvant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 1997
- Primary completion
- Jun 1998 (actual)
- Study completion
- Jun 1998 (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.
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
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: Recombinant MPL- adjuvanted hepatitis B vaccine |
| Group B | Active comparator | Biological: Engerix™-B |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
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 |
|---|---|---|
| Recombinant MPL- adjuvanted hepatitis B vaccineIntramuscular injection, 3 doses | Biological | Group A |
| Engerix™-BIntramuscular injection, 3 doses | Biological | Group B |
Primary outcome
Anti-HBs antibody concentrations
Time frame: At month 7
6 secondary outcomes
Anti-HBs antibody concentrations
Time frame: At months 2, 6, 7 and 12
Occurrence and intensity of solicited local symptoms
Time frame: 4-day follow-up after vaccination
Occurrence, intensity and relationship of solicited general symptoms
Time frame: 4-day follow-up after vaccination
Occurrence, intensity and relationship to vaccination of unsolicited symptoms
Time frame: Within 30 days after vaccination
Incidence of serious AEs
Time frame: Throughout the entire study up to and including 30 days after the last vaccination
Cell mediated immunity
Time frame: At months 0, 2, 6, 7, 12
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 16 Jun 2008.
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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.
Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Recombinant MPL- adjuvanted hepatitis B vaccine and Engerix™-B in people with Hepatitis B, run by GlaxoSmithKline at 1 site in Belgium.
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 5 inclusion and 12 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 16 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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: At month 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2008.