Hepatitis BPhase 2NCT00697775
Safety and Immunogenicity of GSK Bio's Candidate HBV-MPL Vaccines Compared to Engerix™-B, in Healthy Adolescents
A Phase 2 study testing HBV-MPL vaccine Formulation A, HBV-MPL vaccine Formulation B and Engerix™-B in people with Hepatitis B, run by GlaxoSmithKline at 1 site in Germany.
Trial summary
In this study the safety and immunogenicity of 2 different formulations of the candidate HBV-MPL vaccine administered according to a 0, 6-month schedule were explored and compared to that of Engerix™-B in healthy adolescents aged 11 to 15 Read more about this study
- Who is it for?
- Ages 11 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- HBV-MPL vaccine Formulation A, HBV-MPL vaccine Formulation B and Engerix™-B
- 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 siteGermany
- Study dates
- Mar 1998to May 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 11 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age: between 11 and 15 years 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 parents or guardians of the subject and from the subject himself/herself in all subjects 15 years of age.
- If the subject is female, she must be of non-childbearing potential, if of childbearing potential, she must be abstinent or have used an adequate contraceptive for one month prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series
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 of a vaccine not foreseen by the study protocol during the period starting from one week before each dose of vaccine and ending 30 days after.
- Previous vaccination against hepatitis B virus.
- Previous vaccination with vaccine containing MPL.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
Show all 14Show fewer
- 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.
- Axillary temperature of ≥ 37.5° C.
- Administration of immunoglobulin and / or any blood product within the six months preceding the first dose of study vaccine or planned administration during the study period.
- Pregnant or lactating female.
- History of chronic disease deemed by the investigator to be relevant.
- Positive for anti-HBV antibodies at screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Assess the Feasibility of GSK Bio's Candidate HBV / MPL Vaccines Following Different Schedules and Formulations and to Compare Their Safety and Immunogenicity to That of Engerix™-B in Healthy Adolescents Aged 11 to 15
In this study the safety and immunogenicity of 2 different formulations of the candidate HBV-MPL vaccine administered according to a 0, 6-month schedule were explored and compared to that of Engerix™-B in healthy adolescents aged 11 to 15
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 Formulation A, HBV-MPL vaccine Formulation B, Engerix™-B
- Keywords
- Hepatitis 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 Formulation ABiological
Single dose (when extemporaneously co-administered with Engerix™-B) or 2-dose (when administered alone) intramuscular injection
HBV-MPL vaccine Formulation BBiological
2-dose intramuscular injection
Engerix™-BBiological
Single dose (when extemporaneously co-administered with HBV-MPL) or 3-dose (when administered alone) intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | HBV-MPL Formulation A at months 0 and 6 Receives: Biological: HBV-MPL vaccine Formulation A |
| Group B | Experimental | HBV-MPL Formulation B at months 0 and 6 Receives: Biological: HBV-MPL vaccine Formulation B |
| Group C | Experimental | HBV-MPL Formulation A at month 0 and Engerix™-B at month 6 Receives: Biological: HBV-MPL vaccine Formulation A; Biological: Engerix™-B |
| Group D | Active comparator | Engerix™-B at months 0, 1, 6 Receives: Biological: Engerix™-B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Serious adverse experiences (SAE)
Measured: During the study period
Occurrence, intensity and relationship to vaccination of solicited local and general symptoms
Measured: During the 8-day follow-up period after vaccination
Occurrence, intensity and causal relationship of unsolicited adverse events
Measured: 31-day follow-up period after vaccination
Secondary outcomes (2)
Anti-HBs antibody concentrations
Measured: At months 1, 2, 6, and 7
Cell mediated immunity
Measured: At months 1, 6, and 7
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 startMar 1998
- Primary completionMay 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
- NCT00697775
- Sponsor's protocol ID
- 208129/028
- 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 Assess the Feasibility of GSK Bio's Candidate HBV / MPL Vaccines Following Different Schedules and Formulations and to Compare Their Safety and Immunogenicity to That of Engerix™-B in Healthy Adolescents Aged 11 to 15
- ClinicalTrials.gov ID
- NCT00697775
- Acronym / sponsor ID
- 208129/028
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B, Recombinant hepatitis B vaccine, Adjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Mar 1998
- Primary completion
- May 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.
In this study the safety and immunogenicity of 2 different formulations of the candidate HBV-MPL vaccine administered according to a 0, 6-month schedule were explored and compared to that of Engerix™-B in healthy adolescents aged 11 to 15
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
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: HBV-MPL vaccine Formulation AHBV-MPL Formulation A at months 0 and 6 |
| Group B | Experimental | Biological: HBV-MPL vaccine Formulation BHBV-MPL Formulation B at months 0 and 6 |
| Group C | Experimental | Biological: HBV-MPL vaccine Formulation A, Biological: Engerix™-BHBV-MPL Formulation A at month 0 and Engerix™-B at month 6 |
| Group D | Active comparator | Biological: Engerix™-BEngerix™-B at months 0, 1, 6 |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age: between 11 and 15 years 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 parents or guardians of the subject and from the subject himself/herself in all subjects 15 years of age.
- If the subject is female, she must be of non-childbearing potential, if of childbearing potential, she must be abstinent or have used an adequate contraceptive for one month prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series
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 of a vaccine not foreseen by the study protocol during the period starting from one week before each dose of vaccine and ending 30 days after.
- Previous vaccination against hepatitis B virus.
- Previous vaccination with vaccine containing MPL.
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 Formulation ASingle dose (when extemporaneously co-administered with Engerix™-B) or 2-dose (when administered alone) intramuscular injection | Biological | Group A, Group C |
| HBV-MPL vaccine Formulation B2-dose intramuscular injection | Biological | Group B |
| Engerix™-BSingle dose (when extemporaneously co-administered with HBV-MPL) or 3-dose (when administered alone) intramuscular injection | Biological | Group C, Group D |
Primary outcome
Occurrence of Serious adverse experiences (SAE)
Time frame: During the study period
Occurrence, intensity and relationship to vaccination of solicited local and general symptoms
Time frame: During the 8-day follow-up period after vaccination
Occurrence, intensity and causal relationship of unsolicited adverse events
Time frame: 31-day follow-up period after vaccination
2 secondary outcomes
Anti-HBs antibody concentrations
Time frame: At months 1, 2, 6, and 7
Cell mediated immunity
Time frame: At months 1, 6, and 7
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.
Related trials for Hepatitis B
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
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 HBV-MPL vaccine Formulation A, HBV-MPL vaccine Formulation B and Engerix™-B in people with Hepatitis B, run by GlaxoSmithKline at 1 site in Germany.
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 Germany. 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?
Occurrence of Serious adverse experiences (SAE) (time frame: During the study period). The study lists 3 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 16 Jun 2008.