Hepatitis BPhase 1NCT02153320
Study to Evaluate the Persistence of the Cellular and Humoral Immune Response Following Vaccinations With GlaxoSmithKline (GSK) Biologicals' Candidate Vaccines Containing HBsAg and Different Adjuvants in Healthy Adult Volunteers
A Phase 1 study testing Blood Sampling in people with Hepatitis B, run by GlaxoSmithKline at 2 sites in Belgium.
Trial summary
The purpose of this long-term follow-up study was to evaluate the persistence of the cellular and the humoral immune response 4 years after the first dose of GSK Biologicals' investigational vaccine formulations containing HBsAg (used as a model antigen) and an adjuvant. Read more about this study
- Who is it for?
- Ages 22 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Blood Sampling
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 2 sitesBelgium
- Study dates
- 5 Sep 2005to 28 Oct 2005
- 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 22 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who the investigator believes can and will comply with the requirements of the protocol.
- Subjects who took part in and completed study 287615 (NCT00508833).
- Written informed consent obtained from the subject.
- Healthy subjects as established by medical history before entering into the study.
Who cannot join
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the blood sampling, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to the blood sampling.
- Administration of immunoglobulins within the three months preceding the blood sampling or planned administration during the study period.
- Pregnant or lactating female.
- Documented HIV-positive subject.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
GSK Investigational Site
Brussels, 1200
GSK Investigational Site
Ghent, 9000
About this study
Official title: A Long-term Follow-up of a Phase I/II Study to Compare the Persistence and to Perform in Depth Characterisation of the Cellular and Humoral Immune Response Following Vaccinations With GSK Biologicals' Candidate Vaccines Containing HBsAg and Different Adjuvants in Healthy Adult Volunteers
The purpose of this long-term follow-up study was to evaluate the persistence of the cellular and the humoral immune response 4 years after the first dose of GSK Biologicals' investigational vaccine formulations containing HBsAg (used as a model antigen) and an adjuvant.
Read the detailed description
Subjects in this long-term follow-up study were recruited among those subjects who completed the study 287615 (NCT00508833) and who were enrolled in specific groups. All subjects were vaccinated in the study 287615 (NCT00508833) according to a 0, 1, 10 month schedule. No new subjects were enrolled and no vaccine was administered in this long-term follow-up study. There was a single visit at Year 4 at which blood samples for immunogenicity assays were taken.
- Conditions
- Hepatitis B
- Being tested
- Blood Sampling
- Keywords
- HBsAg, Persistence of the immune response, Adjuvants
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood SamplingProcedure or surgery
Single blood sample taken from subjects who had participated in the study 287615 (NCT00508833).
| Study group | Role | What they receive |
|---|---|---|
| HBsAg + adjuvant 1 Group | Experimental | Single blood sample taken from subjects who had received GSK candidate vaccine containing HBsAg together with an adjuvant 1 in study 287615 (NCT00508833). Receives: Procedure: Blood Sampling |
| HBsAg + adjuvant 2 Group | Experimental | Single blood sample taken from subjects who had received GSK candidate vaccine containing HBsAg together with an adjuvant 2 in study 287615 (NCT00508833). Receives: Procedure: Blood Sampling |
| HBsAg + adjuvant 3 Group | Experimental | Single blood sample taken from subjects who had received GSK candidate vaccines containing HBsAg together with an adjuvant 3 in study 287615 (NCT00508833). Receives: Procedure: Blood Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of CD4 and CD8 T cells expressing IFN-γ and/or TNF-α and/or IL-2 and/or CD40L upon short term in vitro stimulation with HbsAg derived peptides using cytokine flow cytometry.
The blood samples at Week 48 were taken during the primary study 287615 (NCT00508833).
Measured: Week 48.
Frequency of CD4 and CD8 T cells expressing IFN-γ and/or TNF-α and/or IL-2 and/or CD40L upon short term in vitro stimulation with HbsAg derived peptides using cytokine flow cytometry.
The blood samples at Week 78 were taken during the primary study 287615 (NCT00508833).
Measured: Week 78.
Frequency of CD4 and CD8 T cells expressing IFN-γ and/or TNF-α and/or IL-2 and/or CD40L upon short term in vitro stimulation with HbsAg derived peptides using cytokine flow cytometry.
Measured: Year 4.
Secondary outcomes (4)
Anti-HBs antibody titres as measured by ELISA.
The blood samples at Week 48 and Week 78 were taken during the primary study 287615 (NCT00508833).
Measured: Week, 48, Week 78, Year 4.
Exploratory analysis of proteins and low molecular weight biomolecules in the serum using ELISA and other techniques to be defined.
The blood samples at Day 0 and Day 1 were taken during the primary study 287615 (NCT00508833).
Measured: Day 0, Day 1.
Frequency of HBsAg specific memory B cells by B Cell Elispot assay.
The blood samples at Week 48 and Week 78 were taken during the primary study 287615 (NCT00508833).
Measured: Week 48, Week 78, Year 4.
Frequency of HBs-specific or non specific T regulatory cells using cytokine flow cytometry and other techniques to be defined.
The blood samples at Day 0, Week 6, Week 46 and Week 48 were taken during the primary study 287615 (NCT00508833).
Measured: Day 0, Week 6, Week 46, Week 48.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study start5 Sep 2005
- Primary completion28 Oct 2005
- Study completion28 Oct 2005
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
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153320
- Sponsor's protocol ID
- 105721
- Status last verified
- May 2017
- First submitted
- 22 May 2014
- Last updated
- 30 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term Follow-up of a Phase I/II Study to Compare the Persistence and to Perform in Depth Characterisation of the Cellular and Humoral Immune Response Following Vaccinations With GSK Biologicals' Candidate Vaccines Containing HBsAg and Different Adjuvants in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT02153320
- Acronym / sponsor ID
- 105721
- Conditions
- Hepatitis B
- Keywords
- HBsAg, Persistence of the immune response, Adjuvants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2005 (actual)
- Primary completion
- 28 Oct 2005 (actual)
- Study completion
- 28 Oct 2005 (actual)
- First posted
- 3 Jun 2014 (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 long-term follow-up study was to evaluate the persistence of the cellular and the humoral immune response 4 years after the first dose of GSK Biologicals' investigational vaccine formulations containing HBsAg (used as a model antigen) and an adjuvant.
Detailed description
Subjects in this long-term follow-up study were recruited among those subjects who completed the study 287615 (NCT00508833) and who were enrolled in specific groups. All subjects were vaccinated in the study 287615 (NCT00508833) according to a 0, 1, 10 month schedule. No new subjects were enrolled and no vaccine was administered in this long-term follow-up study. There was a single visit at Year 4 at which blood samples for immunogenicity assays were taken.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HBsAg + adjuvant 1 Group | Experimental | Procedure: Blood SamplingSingle blood sample taken from subjects who had received GSK candidate vaccine containing HBsAg together with an adjuvant 1 in study 287615 (NCT00508833). |
| HBsAg + adjuvant 2 Group | Experimental | Procedure: Blood SamplingSingle blood sample taken from subjects who had received GSK candidate vaccine containing HBsAg together with an adjuvant 2 in study 287615 (NCT00508833). |
| HBsAg + adjuvant 3 Group | Experimental | Procedure: Blood SamplingSingle blood sample taken from subjects who had received GSK candidate vaccines containing HBsAg together with an adjuvant 3 in study 287615 (NCT00508833). |
Who may qualify
- Ages
- 22 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects who the investigator believes can and will comply with the requirements of the protocol.
- Subjects who took part in and completed study 287615 (NCT00508833).
- Written informed consent obtained from the subject.
- Healthy subjects as established by medical history before entering into the study.
Key exclusion criteria (5 listed)
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the blood sampling, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to the blood sampling.
- Administration of immunoglobulins within the three months preceding the blood sampling or planned administration during the study period.
- Pregnant or lactating female.
- Documented HIV-positive subject.
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 |
|---|---|---|
| Blood SamplingSingle blood sample taken from subjects who had participated in the study 287615 (NCT00508833). | Procedure or surgery | HBsAg + adjuvant 1 Group, HBsAg + adjuvant 2 Group, HBsAg + adjuvant 3 Group |
Primary outcome
Frequency of CD4 and CD8 T cells expressing IFN-γ and/or TNF-α and/or IL-2 and/or CD40L upon short term in vitro stimulation with HbsAg derived peptides using cytokine flow cytometry.
Time frame: Week 48.
The blood samples at Week 48 were taken during the primary study 287615 (NCT00508833).
Frequency of CD4 and CD8 T cells expressing IFN-γ and/or TNF-α and/or IL-2 and/or CD40L upon short term in vitro stimulation with HbsAg derived peptides using cytokine flow cytometry.
Time frame: Week 78.
The blood samples at Week 78 were taken during the primary study 287615 (NCT00508833).
Frequency of CD4 and CD8 T cells expressing IFN-γ and/or TNF-α and/or IL-2 and/or CD40L upon short term in vitro stimulation with HbsAg derived peptides using cytokine flow cytometry.
Time frame: Year 4.
4 secondary outcomes
Anti-HBs antibody titres as measured by ELISA.
Time frame: Week, 48, Week 78, Year 4.
Exploratory analysis of proteins and low molecular weight biomolecules in the serum using ELISA and other techniques to be defined.
Time frame: Day 0, Day 1.
Frequency of HBsAg specific memory B cells by B Cell Elispot assay.
Time frame: Week 48, Week 78, Year 4.
Frequency of HBs-specific or non specific T regulatory cells using cytokine flow cytometry and other techniques to be defined.
Time frame: Day 0, Week 6, Week 46, Week 48.
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 30 May 2017.
- Results for study 105721 can be found on the GSK Clinical Study RegisterLink provided by the sponsor.
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.
GSK Clinical Trials study director
GlaxoSmithKline
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Blood Sampling in people with Hepatitis B, run by GlaxoSmithKline at 2 sites 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 5 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 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Frequency of CD4 and CD8 T cells expressing IFN-γ and/or TNF-α and/or IL-2 and/or CD40L upon short term in vitro stimulation with HbsAg derived peptides using cytokine flow cytometry. (time frame: Week 48.). 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 30 May 2017.