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| ID | Type | Description | Link |
|---|---|---|---|
| 109674 |
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The safety and immunogenicity of the GSK324332A vaccine has been evaluated up to Month 12 post-vaccination in the primary study. In the extension studies presented here, the persistence of the cellular and humoral immune responses will be evaluated 30 and 42 months after the first vaccination in young and elderly adults who received the GSK324332A vaccine. This protocol posting deals only with objectives & outcome measures of the extension phase at Months 30 and 42. No new recruitment will be done in these extension phases of the primary study. No vaccines are administered in this phase of the study.
All subjects in these extension phases of the study were previously vaccinated with the investigational herpes zoster vaccine GSK1437173A. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Further details on the primary study can be found on our GSK study register (https://www.gsk-studyregister.com/advanced-search) by searching on the GSK study identifier 101501.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK1437173A 18-30 Years Old Group | Experimental | Subjects aged 18 to 30 years old receiving 2 doses GSK1437173A vaccine in the primary study. |
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| GSK1437173A 50-70 Years Old Group | Experimental | Subjects aged 50 to 70 years old receiving 2 doses GSK1437173A vaccine in the primary study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling for assay of persistence of immunogenicity | Procedure | Two blood samples: 30 and 42 months after first vaccination |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequencies of Glycoprotein E (gE)-Specific Cluster of Differentiation 4 (CD4) / CD8 T Cells With at Least Two Antigen-specific Cytokines: Interferon Gamma (IFN-γ), Interleukin 2 (IL-2), Tumor Necrosis Factor Alpha (TNF-α), CD 40 Ligand (CD40L). | The analysis focused on those gE-specific CD4 T cells secreting at least two different cytokines among IFN-γ, IL-2, TNF-α, and CD40L as determined by intracellular cytokine staining (ICS). No analysis of the immunogenicity data on CD8 T cell response to gE was performed, since no long-term vaccine effect on gE-specific CD8 T cell response was detected. | At Month 30 after the first vaccination. |
| Frequencies of Varicella Zoster Virus (VZV)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). | The analysis focused on those VZV-specific CD4 T cells secreting at least two different cytokines among IFN-γ, IL-2, TNF-α, CD40L as determined by intracellular cytokine staining (ICS). No analysis of the immunogenicity data on CD8 T cell response to VZV was performed, since no long-term vaccine effect on VZV-specific CD8 T cell response was detected. | At Month 30 after the first vaccination |
| Frequencies of Glycoprotein E (gE)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). | The analysis focused on those gE-specific CD4 T cells secreting at least two different cytokines among IFN-γ, IL-2, TNF-α, CD40L as determined by intracellular cytokine staining (ICS). No analysis of the immunogenicity data on CD8 T cell response to gE was performed, since no long-term vaccine effect on gE-specific CD8 T cell response was detected. | At Month 42 after the first vaccination |
| Frequencies of Varicella Zoster Virus (VZV)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). | The analysis focused on those VZV-specific CD4 T cells secreting at least two different cytokines among IFN-γ, IL-2, TNF-α, CD40L as determined by intracellular cytokine staining (ICS). No analysis of the immunogenicity data on CD8 T cell response to VZV was performed, since no long-term vaccine effect on VZV-specific CD8 T cell response was detected. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequencies of gE- and VZV-specific CD4/CD8 T Cells With Antigen-specific IFN-γ and/or IL-2 and/or TNF-α and/or CD40L Secretion/Expression. | The analysis focused on those gE- and VZV-specific CD4 T cells secreting any cytokines among IFN-γ, IL-2, TNF-α, CD40L as determined by intracellular cytokine staining (ICS). No analysis of the immunogenicity data on CD8 T cell response to gE or VZV was performed, since no long-term vaccine effect on gE- and VZV-specific CD8 T cell response was detected. |
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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 | Ghent | 9000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30975567 | Derived | Keersmaekers N, Ogunjimi B, Van Damme P, Beutels P, Hens N. An ODE-based mixed modelling approach for B- and T-cell dynamics induced by Varicella-Zoster Virus vaccines in adults shows higher T-cell proliferation with Shingrix than with Varilrix. Vaccine. 2019 May 1;37(19):2537-2553. doi: 10.1016/j.vaccine.2019.03.075. Epub 2019 Apr 8. | |
| 22872734 |
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| ID | Title | Description |
|---|---|---|
| FG000 | GSK1437173A 18-30 Years Old Group | Subjects aged 18 to 30 years old primed with 2 doses GSK1437173A vaccine. |
| FG001 | GSK1437173A 50-70 Years Old Group | Subjects aged 50 to 70 years old primed with 2 doses GSK1437173A vaccine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Month 30 (109671 Study) |
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| ||||||||||||||||||
| Month 42 (109674 Study) |
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| ID | Title | Description |
|---|---|---|
| BG000 | GSK1437173A 18-30 Years Old Group | Subjects aged 18 to 30 years old primed with 2 doses GSK1437173A vaccine. |
| BG001 | GSK1437173A 50-70 Years Old Group | Subjects aged 50 to 70 years old primed with 2 doses GSK1437173A vaccine. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | For Month 30 (109671 Study) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Frequencies of Glycoprotein E (gE)-Specific Cluster of Differentiation 4 (CD4) / CD8 T Cells With at Least Two Antigen-specific Cytokines: Interferon Gamma (IFN-γ), Interleukin 2 (IL-2), Tumor Necrosis Factor Alpha (TNF-α), CD 40 Ligand (CD40L). | The analysis focused on those gE-specific CD4 T cells secreting at least two different cytokines among IFN-γ, IL-2, TNF-α, and CD40L as determined by intracellular cytokine staining (ICS). No analysis of the immunogenicity data on CD8 T cell response to gE was performed, since no long-term vaccine effect on gE-specific CD8 T cell response was detected. | The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed. | Posted | Mean | Standard Deviation | gE-specific CD4 cells/million CD4 cells | At Month 30 after the first vaccination. |
|
Serious adverse events were collected throughout the study, up to Month 42.
Other (Not Including Serious) Adverse Events were not planned to be collected in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GSK1437173A 18-30 Years Old Group | Subjects aged 18 to 30 years old primed with 2 doses GSK1437173A vaccine. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus 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 |
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| At Month 42 after the first vaccination |
| At Months 30 and 42 after the first vaccination |
| Anti-gE Antibody (Ab) Concentrations | As determined by the Enzyme-Linked Immunosorbent Assay (ELISA) and expressed as ELISA units per milliliter (EL.U/mL). | At months 30 and 42 after the first vaccination |
| Anti-VZV Ab Concentrations | As determined by the Enzyme-Linked Immunosorbent Assay (ELISA) and expressed as ELISA units per milliliter (EL.U/mL). | At months 30 and 42 after the first vaccination |
| Frequencies of gE-specific Memory B Cells | As determined by Enzyme-Linked ImmunoSpot (ELISPOT) assay. | At months 30 and 42 after the first vaccination |
| Frequencies of VZV-specific Memory B Cells | As determined by Enzyme-Linked ImmunoSpot (ELISPOT) assay. | At months 30 and 42 after the first vaccination |
| Number of Subjects With Any Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. | From Month 30 to study end Month 42 after the first vaccination |
| Number of Subjects With Clinically Diagnosed Herpes Zoster (HZ) Episodes | This assay tabulated the number of subjects with clinically diagnosed HZ episodes, defined as any cutaneous HZ-like rash. | From last primary study visit (Month 12) to study end at Month 42 after the first vaccination. |
| Leroux-Roels I, Leroux-Roels G, Clement F, Vandepapeliere P, Vassilev V, Ledent E, Heineman TC. A phase 1/2 clinical trial evaluating safety and immunogenicity of a varicella zoster glycoprotein e subunit vaccine candidate in young and older adults. J Infect Dis. 2012 Oct;206(8):1280-90. doi: 10.1093/infdis/jis497. Epub 2012 Aug 7. |
| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
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| Age, Continuous | For Month 42 (109674 Study) | Mean | Standard Deviation | Years |
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| Sex: Female, Male | For Month 30 (109671 Study) | Count of Participants | Participants |
|
| Sex: Female, Male | For Month 42 (109674 Study) | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
Subjects aged 18 to 30 years old primed with 2 doses GSK1437173A vaccine. |
| OG001 | GSK1437173A 50-70 Years Old Group | Subjects aged 50 to 70 years old primed with 2 doses GSK1437173A vaccine. |
|
|
| Primary | Frequencies of Varicella Zoster Virus (VZV)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). | The analysis focused on those VZV-specific CD4 T cells secreting at least two different cytokines among IFN-γ, IL-2, TNF-α, CD40L as determined by intracellular cytokine staining (ICS). No analysis of the immunogenicity data on CD8 T cell response to VZV was performed, since no long-term vaccine effect on VZV-specific CD8 T cell response was detected. | The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed. | Posted | Mean | Standard Deviation | VZV-specific CD4 cells/million CD4 cells | At Month 30 after the first vaccination |
|
|
|
| Primary | Frequencies of Glycoprotein E (gE)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). | The analysis focused on those gE-specific CD4 T cells secreting at least two different cytokines among IFN-γ, IL-2, TNF-α, CD40L as determined by intracellular cytokine staining (ICS). No analysis of the immunogenicity data on CD8 T cell response to gE was performed, since no long-term vaccine effect on gE-specific CD8 T cell response was detected. | The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed. | Posted | Mean | Standard Deviation | gE-specific CD4 cells/million CD4 cells | At Month 42 after the first vaccination |
|
|
|
| Primary | Frequencies of Varicella Zoster Virus (VZV)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). | The analysis focused on those VZV-specific CD4 T cells secreting at least two different cytokines among IFN-γ, IL-2, TNF-α, CD40L as determined by intracellular cytokine staining (ICS). No analysis of the immunogenicity data on CD8 T cell response to VZV was performed, since no long-term vaccine effect on VZV-specific CD8 T cell response was detected. | The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed. | Posted | Mean | Standard Deviation | VZV-specific CD4 cells/million CD4 cells | At Month 42 after the first vaccination |
|
|
|
| Secondary | Frequencies of gE- and VZV-specific CD4/CD8 T Cells With Antigen-specific IFN-γ and/or IL-2 and/or TNF-α and/or CD40L Secretion/Expression. | The analysis focused on those gE- and VZV-specific CD4 T cells secreting any cytokines among IFN-γ, IL-2, TNF-α, CD40L as determined by intracellular cytokine staining (ICS). No analysis of the immunogenicity data on CD8 T cell response to gE or VZV was performed, since no long-term vaccine effect on gE- and VZV-specific CD8 T cell response was detected. | The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed. | Posted | Mean | Standard Deviation | CD4 cells/million T-cells | At Months 30 and 42 after the first vaccination |
|
|
|
| Secondary | Anti-gE Antibody (Ab) Concentrations | As determined by the Enzyme-Linked Immunosorbent Assay (ELISA) and expressed as ELISA units per milliliter (EL.U/mL). | The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At months 30 and 42 after the first vaccination |
|
|
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| Secondary | Anti-VZV Ab Concentrations | As determined by the Enzyme-Linked Immunosorbent Assay (ELISA) and expressed as ELISA units per milliliter (EL.U/mL). | The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At months 30 and 42 after the first vaccination |
|
|
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| Secondary | Frequencies of gE-specific Memory B Cells | As determined by Enzyme-Linked ImmunoSpot (ELISPOT) assay. | The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed. | Posted | Mean | Standard Deviation | gE-specific B-cells/million B-cells | At months 30 and 42 after the first vaccination |
|
|
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| Secondary | Frequencies of VZV-specific Memory B Cells | As determined by Enzyme-Linked ImmunoSpot (ELISPOT) assay. | The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed. | Posted | Mean | Standard Deviation | VZV-specific B-cells/million B-cells | At months 30 and 42 after the first vaccination |
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|
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| Secondary | Number of Subjects With Any Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. | The analysis was performed on the Total cohort for persistence which included all subjects previously primed with 2 doses of GSK1437173A and were enrolled in the current study. | Posted | Count of Participants | Participants | From Month 30 to study end Month 42 after the first vaccination |
|
|
|
| Secondary | Number of Subjects With Clinically Diagnosed Herpes Zoster (HZ) Episodes | This assay tabulated the number of subjects with clinically diagnosed HZ episodes, defined as any cutaneous HZ-like rash. | The analysis was performed on the Total cohort for persistence which included all subjects previously primed with 2 doses of GSK1437173A and were enrolled in the current study. | Posted | Count of Participants | Participants | From last primary study visit (Month 12) to study end at Month 42 after the first vaccination. |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 0 |
| EG001 | GSK1437173A 50-70 Years Old Group | Subjects aged 50 to 70 years old primed with 2 doses GSK1437173A vaccine. | 0 | 30 | 0 | 30 | 0 | 0 |
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D007239 | Infections |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| gE, IFN-γ and IL-2/TNF-α/CD40L, Month 30 |
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| gE, TNF-α and IFN-γ/IL-2/CD40L, Month 30 |
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| gE, CD40L and IFN-γ/IL-2/TNF-α, Month 30 |
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| gE, IL-2 and IFN-γ/TNF-α/CD40L, Month 42 |
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| gE, IFN-γ and IL-2/TNF-α/CD40L, Month 42 |
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| gE, TNF-α and IFN-γ/IL-2/CD40L, Month 42 |
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| gE, CD40L and IFN-γ/IL-2/TNF-α, Month 42 |
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| VZV, IL-2 and IFN-γ/TNF-α/CD40L, Month 30 |
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| VZV, IFN-γ and IL-2/TNF-α/CD40L, Month 30 |
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| VZV, TNF-α and IFN-γ/IL-2/CD40L, Month 30 |
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| VZV, CD40L and IFN-γ/IL-2/TNF-α, Month 30 |
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| VZV, IL-2 and IFN-γ/TNF-α/CD40L, Month 42 |
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| VZV, IFN-γ and IL-2/TNF-α/CD40L, Month 42 |
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| VZV, TNF-α and IFN-γ/IL-2/CD40L, Month 42 |
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| VZV, CD40L and IFN-γ/IL-2/TNF-α, Month 42 |
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| At Month 42 |
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| At Month 42 |
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| At Month 42 |
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| At Month 42 |
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