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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Sampling | Procedure | Single blood sample taken from subjects who had participated in the study 287615 (NCT00508833). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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. | Year 4. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Brussels | 1200 | Belgium | |||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Results for study 105721 can be found on the GSK Clinical Study Register | View source |
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The blood samples at Day 0 and Day 1 were taken during the primary study 287615 (NCT00508833). |
| 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). | 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). | Day 0, Week 6, Week 46, Week 48. |
| Ghent |
| 9000 |
| Belgium |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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