Hepatitis BPhase 2NCT00697853
Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine (2 Doses), and of Engerix™-B (3 Doses) in Healthy Adults
A Phase 2 study testing Engerix™-B and HBV-MPL vaccine 208129 in people with Hepatitis B, run by GlaxoSmithKline at 1 site in Belgium.
Trial summary
This study is undertaken to assess the immune response and safety profile of 4 lots of the novel adjuvanted hepatitis B vaccine that were formulated following different processes, with Engerix™-B as the control vaccine Read more about this study
- Who is it for?
- Ages 15 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Engerix™-B and HBV-MPL vaccine 208129
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 1998to Jul 1999
- 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 15 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- A male or female between 15 and 50 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 and/or from the parents or guardians of 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 vaccination and up to two months after the last vaccination
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.
- Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination.
- 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.
- Previous vaccination against hepatitis B.
- History of significant and persisting hematological, hepatic, renal, cardiac or respiratory disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
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- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or 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.
- Oral temperature of ≥37.5°C (99.5°F).
- 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.
- History of chronic alcohol consumption and/or intravenous drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Evaluate the Immunogenicity and Safety of GSK Biologicals' Novel Adjuvanted Hepatitis B Vaccine Administered According to a 0, 6 Month Schedule and of Engerix™-B Administered According to a 0, 1, 6 Month Schedule in Healthy Adults
This study is undertaken to assess the immune response and safety profile of 4 lots of the novel adjuvanted hepatitis B vaccine that were formulated following different processes, with Engerix™-B as the control vaccine
Read the detailed description
This is an open, randomized study with five groups, but the four groups receiving HBV-MPL candidate vaccine are double-blinded.
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 208129
- Keywords
- Hepatitis B, Adjuvanted hepatitis B vaccine, 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
3-dose intramuscular injection
HBV-MPL vaccine 208129Biological
2-dose intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Not described Receives: Biological: Engerix™-B |
| Group B | Experimental | Not described Receives: Biological: HBV-MPL vaccine 208129 |
| Group C | Experimental | Not described Receives: Biological: HBV-MPL vaccine 208129 |
| Group D | Experimental | Not described Receives: Biological: HBV-MPL vaccine 208129 |
| Group E | Experimental | Not described Receives: Biological: HBV-MPL vaccine 208129 |
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 (4)
Anti-HBs antibody concentrations
Measured: At months 1, 2 and 6
Occurrence and intensity of solicited local and general symptoms
Measured: 4-day follow-up period after each vaccination
Occurrence, intensity and relationship to vaccination of unsolicited symptoms
Measured: 30-day follow-up period after each vaccination
Occurrence, intensity and relationship to vaccination of SAEs
Measured: Throughout the entire study
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 1998
- Primary completionJul 1999
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
- None (open label)
- Enrolment
- 200 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
- NCT00697853
- Sponsor's protocol ID
- 208129/030
- 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 Evaluate the Immunogenicity and Safety of GSK Biologicals' Novel Adjuvanted Hepatitis B Vaccine Administered According to a 0, 6 Month Schedule and of Engerix™-B Administered According to a 0, 1, 6 Month Schedule in Healthy Adults
- ClinicalTrials.gov ID
- NCT00697853
- Acronym / sponsor ID
- 208129/030
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B, Adjuvanted hepatitis B vaccine, Recombinant hepatitis B vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 1998
- Primary completion
- Jul 1999 (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.
This study is undertaken to assess the immune response and safety profile of 4 lots of the novel adjuvanted hepatitis B vaccine that were formulated following different processes, with Engerix™-B as the control vaccine
Detailed description
This is an open, randomized study with five groups, but the four groups receiving HBV-MPL candidate vaccine are double-blinded.
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
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Biological: Engerix™-B |
| Group B | Experimental | Biological: HBV-MPL vaccine 208129 |
| Group C | Experimental | Biological: HBV-MPL vaccine 208129 |
| Group D | Experimental | Biological: HBV-MPL vaccine 208129 |
| Group E | Experimental | Biological: HBV-MPL vaccine 208129 |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- A male or female between 15 and 50 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 and/or from the parents or guardians of 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 vaccination and up to two months after the last vaccination
Key exclusion criteria (14 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.
- Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination.
- 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.
- Previous vaccination against hepatitis B.
- History of significant and persisting hematological, hepatic, renal, cardiac or respiratory disease.
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™-B3-dose intramuscular injection | Biological | Group A |
| HBV-MPL vaccine 2081292-dose intramuscular injection | Biological | Group B, Group C, Group D, Group E |
Primary outcome
Anti-HBs antibody concentrations
Time frame: At month 7
4 secondary outcomes
Anti-HBs antibody concentrations
Time frame: At months 1, 2 and 6
Occurrence and intensity of solicited local and general symptoms
Time frame: 4-day follow-up period after each vaccination
Occurrence, intensity and relationship to vaccination of unsolicited symptoms
Time frame: 30-day follow-up period after each vaccination
Occurrence, intensity and relationship to vaccination of SAEs
Time frame: Throughout the entire study
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 2 study testing Engerix™-B and HBV-MPL vaccine 208129 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 14 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 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-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.