Hepatitis BPhase 1NCT00699231
Evaluation of Immunogenicity, Reactogenicity and Safety of HBV-MPL Vaccine vs Engerix™-B, in Haemodialysis Patients
A Phase 1 study testing HBV-MPL vaccine 208129 and Engerix™-B in people with Hepatitis B, run by GlaxoSmithKline at 1 site in Belgium.
Trial summary
This trial is designed to evaluate the immunogenicity, reactogenicity and safety of an MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in haemodialysis patients with or without previous vaccination against hepatitis B Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 1992to Dec 1992
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dialysis patients
- A medical examination including physical examination and medical history as well as serological screening established acceptability for enrollment into the study.
- Age: from 18 years onwards
- Seronegative for anti- hepatitis antibodies
Who cannot join
- History of persistent hepatic, cardiac or respiratory disease
- Any acute disease at the moment of entry into the study
- Chronic alcohol consumption
- Hepatomegaly, right upper quadrant pain or tenderness
- Any treatment with coticosteroids or immunomodulating drugs
- Known hypersensitivity to any component of the vaccine
- 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, Reactogenicity and Safety of GSK Biologicals' (Previously SmithKline Beecham Biologicals') MPL-Adjuvanted Recombinant Hepatitis B Vaccine Versus Engerix™-B, in Haemodialysis Patients
This trial is designed to evaluate the immunogenicity, reactogenicity and safety of an MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in haemodialysis patients with or without previous vaccination against hepatitis 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, 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.
HBV-MPL vaccine 208129Biological
IM injection
Engerix™-BBiological
IM injection
| Study group | Role | What they receive |
|---|---|---|
| Group A1 | Active comparator | Non-responders to vaccination after at least 7 previous injections Receives: Biological: Engerix™-B |
| Group A2 | Experimental | Non-responders to vaccination after at least 7 previous injections Receives: Biological: HBV-MPL vaccine 208129 |
| Group B1 | Active comparator | Vaccine-responders requiring a booster dose Receives: Biological: Engerix™-B |
| Group B2 | Experimental | Vaccine-responders requiring a booster dose Receives: Biological: HBV-MPL vaccine 208129 |
| Group C1 | Active comparator | Volunteers participating in the hospital's vaccination program Receives: Biological: Engerix™-B |
| Group C2 | Experimental | Volunteers participating in the hospital's vaccination program Receives: Biological: HBV-MPL vaccine 208129 |
| Group D1 | Active comparator | Unvaccinated haemodialysis patients Receives: Biological: Engerix™-B |
| Group D2 | Experimental | Unvaccinated haemodialysis patients Receives: Biological: HBV-MPL vaccine 208129 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence and intensity of solicited local and general symptoms
Measured: 4-day follow-up period after each vaccination
Occurrence of unsolicited adverse events
Measured: During the course of the study
Occurrence of serious adverse events
Measured: During the course of the study
Anti-HBs antibody concentrations
Measured: Pre, Day 0, Day 30, Day 60, Day 90, Day 120, D180, D210 depending on group allocation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startFeb 1992
- Primary completionDec 1992
- Study completionDec 1992
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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 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
- NCT00699231
- Sponsor's protocol ID
- 208129/002
- Status last verified
- Jun 2008
- First submitted
- 13 Jun 2008
- Last updated
- 17 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Immunogenicity, Reactogenicity and Safety of GSK Biologicals' (Previously SmithKline Beecham Biologicals') MPL-Adjuvanted Recombinant Hepatitis B Vaccine Versus Engerix™-B, in Haemodialysis Patients
- ClinicalTrials.gov ID
- NCT00699231
- Acronym / sponsor ID
- 208129/002
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B, Engerix™-B, Recombinant hepatitis B vaccine, Adjuvant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Feb 1992
- Primary completion
- Dec 1992 (actual)
- Study completion
- Dec 1992 (actual)
- First posted
- 17 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.
This trial is designed to evaluate the immunogenicity, reactogenicity and safety of an MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in haemodialysis patients with or without previous vaccination against hepatitis 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
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Group A1 | Active comparator | Biological: Engerix™-BNon-responders to vaccination after at least 7 previous injections |
| Group A2 | Experimental | Biological: HBV-MPL vaccine 208129Non-responders to vaccination after at least 7 previous injections |
| Group B1 | Active comparator | Biological: Engerix™-BVaccine-responders requiring a booster dose |
| Group B2 | Experimental | Biological: HBV-MPL vaccine 208129Vaccine-responders requiring a booster dose |
| Group C1 | Active comparator | Biological: Engerix™-BVolunteers participating in the hospital's vaccination program |
| Group C2 | Experimental | Biological: HBV-MPL vaccine 208129Volunteers participating in the hospital's vaccination program |
| Group D1 | Active comparator | Biological: Engerix™-BUnvaccinated haemodialysis patients |
| Group D2 | Experimental | Biological: HBV-MPL vaccine 208129Unvaccinated haemodialysis patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Dialysis patients
- A medical examination including physical examination and medical history as well as serological screening established acceptability for enrollment into the study.
- Age: from 18 years onwards
- Seronegative for anti- hepatitis antibodies
Key exclusion criteria (7 listed)
- History of persistent hepatic, cardiac or respiratory disease
- Any acute disease at the moment of entry into the study
- Chronic alcohol consumption
- Hepatomegaly, right upper quadrant pain or tenderness
- Any treatment with coticosteroids or immunomodulating drugs
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 208129IM injection | Biological | Group A2, Group B2, Group C2, Group D2 |
| Engerix™-BIM injection | Biological | Group A1, Group B1, Group C1, Group D1 |
Primary outcome
Occurrence and intensity of solicited local and general symptoms
Time frame: 4-day follow-up period after each vaccination
Occurrence of unsolicited adverse events
Time frame: During the course of the study
Occurrence of serious adverse events
Time frame: During the course of the study
Anti-HBs antibody concentrations
Time frame: Pre, Day 0, Day 30, Day 60, Day 90, Day 120, D180, D210 depending on group allocation
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 17 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 1 study testing HBV-MPL vaccine 208129 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 4 inclusion and 7 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 17 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Occurrence and intensity of solicited local and general symptoms (time frame: 4-day follow-up period after each vaccination). The study lists 4 primary outcomes in all. 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 17 Jun 2008.