Hepatitis BPhase 2NCT00697229
Immunogenicity & Reactogenicity of HBV-MPL Vaccine and Engerix™-B in Healthy Adults Following 2 Different Schedules
A Phase 2 study testing Engerix™-B and HBV-MPL vaccine in people with Hepatitis B, run by GlaxoSmithKline at 1 site in Belgium.
Trial summary
The purpose of this study is to evaluate the safety, immunogenicity and reactogenicity of MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in healthy adult volunteers following two different schedules: 0, 2 months and 0, 6 months Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Engerix™-B and HBV-MPL vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 1992to Dec 1998
- Phase
- Phase 2
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 18 and 40 years old.
- Written informed consent will have been obtained from the subjects.
- Good physical condition as established by physical examination and history taking at the time of entry.
- Female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry.
Who cannot join
- Positive titres for anti hepatitis B antibodies.
- Any vaccination against hepatitis B in the past.
- Elevated serum liver enzymes.
- History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
- Axillary temperature > 37°C at the time of injection.
- Any acute disease at the moment of entry.
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- Chronic alcohol consumption.
- 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.
- Administration of any other vaccine(s) or any immunoglobulin during the study period.
- Simultaneous participation in any other clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Evaluate the Immunogenicity and Reactogenicity of GSK Biologicals' MPL-Adjuvanted Recombinant Hepatitis B Vaccine in Comparison With Those of Engerix™-B in Healthy Adult Volunteers Following 2 Different Schedules
The purpose of this study is to evaluate the safety, immunogenicity and reactogenicity of MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in healthy adult volunteers following two different schedules: 0, 2 months and 0, 6 months
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
- Engerix™-B, HBV-MPL vaccine
- Keywords
- Hepatitis B, Engerix™-B, Recombinant hepatitis B 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.
Engerix™-BBiological
Intramuscular injection, 1 or 3 doses
HBV-MPL vaccineBiological
Intramuscular injection, 1 or 3 doses
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Subjects will receive HBV-MPL vaccine in the primary schedule 0, 2 months and will receive a booster dose of HBV-MPL vaccine at 70 months Receives: Biological: HBV-MPL vaccine |
| Group B | Experimental | Subjects will receive HBV-MPL vaccine in the primary schedule 0, 2 months and will receive a booster dose of Engerix™-B vaccine at 70 months Receives: Biological: Engerix™-B; Biological: HBV-MPL vaccine |
| Group C | Experimental | Subjects will receive Engerix™-B vaccine in the primary schedule 0, 2 months and will receive a booster dose of HBV-MPL vaccine at 70 months Receives: Biological: Engerix™-B |
| Group D | Experimental | Subjects will receive Engerix™-B vaccine in the primary schedule 0, 2 months and will receive a booster dose of Engerix™-B vaccine at 70 months Receives: Biological: Engerix™-B; Biological: HBV-MPL vaccine |
| Group E | Experimental | Subjects will receive HBV-MPL vaccine in the primary schedule 0, 6 months and will receive a booster dose of HBV-MPL vaccine at 70 months Receives: Biological: HBV-MPL vaccine |
| Group F | Experimental | Subjects will receive HBV-MPL vaccine in the primary schedule 0, 6 months and will receive a booster dose of Engerix™-B vaccine at 70 months Receives: Biological: Engerix™-B; Biological: HBV-MPL vaccine |
| Group G | Experimental | Subjects will receive Engerix™-B vaccine in the primary schedule 0, 6 months and will receive a booster dose of HBV-MPL vaccine at 70 months Receives: Biological: Engerix™-B |
| Group H | Experimental | Subjects will receive Engerix™-B vaccine in the primary schedule 0, 6 months and will receive a booster dose of Engerix™-B vaccine at 70 months Receives: Biological: Engerix™-B; Biological: HBV-MPL vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-hepatitis B surface antigen (HBs) antibody concentrations
Measured: One month after the full primary vaccination course and one month after the booster vaccination at 70 months
Secondary outcomes (5)
Anti-HBs antibody concentrations
Measured: Months 1, 2, 3, 6, 12, 13, 42
Serious adverse experiences (SAE).
Measured: Throughout the study period
Occurrence and intensity of solicited local symptoms
Measured: 8-day follow-up after vaccination
Occurrence, intensity and relationship of solicited general symptoms
Measured: 8-day follow-up after vaccination
Incidence of unsolicited symptoms
Measured: During the 30-day follow-up after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2008 (estimated)
- Study startSep 1992
- Primary completionMay 1996
- Study completionDec 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 99 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
- NCT00697229
- Sponsor's protocol ID
- 208129/004
- Status last verified
- Jun 2008
- First submitted
- 11 Jun 2008
- Last updated
- 13 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Immunogenicity and Reactogenicity of GSK Biologicals' MPL-Adjuvanted Recombinant Hepatitis B Vaccine in Comparison With Those of Engerix™-B in Healthy Adult Volunteers Following 2 Different Schedules
- ClinicalTrials.gov ID
- NCT00697229
- Acronym / sponsor ID
- 208129/004
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B, Engerix™-B, Recombinant hepatitis B vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 1992
- Primary completion
- May 1996 (actual)
- Study completion
- Dec 1998 (actual)
- First posted
- 13 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 evaluate the safety, immunogenicity and reactogenicity of MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in healthy adult volunteers following two different schedules: 0, 2 months and 0, 6 months
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
- Double blind
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: HBV-MPL vaccineSubjects will receive HBV-MPL vaccine in the primary schedule 0, 2 months and will receive a booster dose of HBV-MPL vaccine at 70 months |
| Group B | Experimental | Biological: Engerix™-B, Biological: HBV-MPL vaccineSubjects will receive HBV-MPL vaccine in the primary schedule 0, 2 months and will receive a booster dose of Engerix™-B vaccine at 70 months |
| Group C | Experimental | Biological: Engerix™-BSubjects will receive Engerix™-B vaccine in the primary schedule 0, 2 months and will receive a booster dose of HBV-MPL vaccine at 70 months |
| Group D | Experimental | Biological: Engerix™-B, Biological: HBV-MPL vaccineSubjects will receive Engerix™-B vaccine in the primary schedule 0, 2 months and will receive a booster dose of Engerix™-B vaccine at 70 months |
| Group E | Experimental | Biological: HBV-MPL vaccineSubjects will receive HBV-MPL vaccine in the primary schedule 0, 6 months and will receive a booster dose of HBV-MPL vaccine at 70 months |
| Group F | Experimental | Biological: Engerix™-B, Biological: HBV-MPL vaccineSubjects will receive HBV-MPL vaccine in the primary schedule 0, 6 months and will receive a booster dose of Engerix™-B vaccine at 70 months |
| Group G | Experimental | Biological: Engerix™-BSubjects will receive Engerix™-B vaccine in the primary schedule 0, 6 months and will receive a booster dose of HBV-MPL vaccine at 70 months |
| Group H | Experimental | Biological: Engerix™-B, Biological: HBV-MPL vaccineSubjects will receive Engerix™-B vaccine in the primary schedule 0, 6 months and will receive a booster dose of Engerix™-B vaccine at 70 months |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Between 18 and 40 years old.
- Written informed consent will have been obtained from the subjects.
- Good physical condition as established by physical examination and history taking at the time of entry.
- Female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry.
Key exclusion criteria (11 listed)
- Positive titres for anti hepatitis B antibodies.
- Any vaccination against hepatitis B in the past.
- Elevated serum liver enzymes.
- History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
- Axillary temperature > 37°C at the time of injection.
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 |
|---|---|---|
| Engerix™-BIntramuscular injection, 1 or 3 doses | Biological | Group B, Group C, Group D, Group F, Group G, Group H |
| HBV-MPL vaccineIntramuscular injection, 1 or 3 doses | Biological | Group A, Group B, Group D, Group E, Group F, Group H |
Primary outcome
Anti-hepatitis B surface antigen (HBs) antibody concentrations
Time frame: One month after the full primary vaccination course and one month after the booster vaccination at 70 months
5 secondary outcomes
Anti-HBs antibody concentrations
Time frame: Months 1, 2, 3, 6, 12, 13, 42
Serious adverse experiences (SAE).
Time frame: Throughout the study period
Occurrence and intensity of solicited local symptoms
Time frame: 8-day follow-up after vaccination
Occurrence, intensity and relationship of solicited general symptoms
Time frame: 8-day follow-up after vaccination
Incidence of unsolicited symptoms
Time frame: During the 30-day follow-up after vaccination
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 13 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 2 study testing Engerix™-B and HBV-MPL vaccine 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 4 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 13 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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-hepatitis B surface antigen (HBs) antibody concentrations (time frame: One month after the full primary vaccination course and one month after the booster vaccination at 70 months). 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 13 Jun 2008.