Herpes Zoster
Conditions
Keywords
GSK Biologicals, Varicella Zoster Virus (VZV), Intracellular cytokine staining (ICS), Vaccine, Cell mediated immunity (CMI), Herpes Zoster (HZ), Shingles
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREBlood sampling for assay of persistence of immunogenicity
Two blood samples: 30 and 42 months after first vaccination
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study; * Subjects who successfully completed the primary study and who did not receive Varilrix in the primary study; * Written informed consent obtained from the subject; * Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) within 1 month preceding the study start, or planned use during the study period; * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first study procedure, including corticosteroids, except inhaled and topical steroids are allowed; * Administration or planned administration of a vaccine not foreseen by the study protocol within 2 weeks before the first study procedure, with the exception of the Influenza vaccine, which can be administered 1 week preceding the first study procedure; * Previous vaccination against HZ, except the study vaccine administered in the primary study; * History of HZ (shingles); * Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination; * Administration of immunoglobulins and/or any blood products within the 3 months preceding the first study procedure or planned administration during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | At Month 30 after the first vaccination. | 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. |
| 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). | At Month 30 after the first vaccination | 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. |
| Frequencies of Glycoprotein E (gE)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). | At Month 42 after the first vaccination | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequencies of gE-specific Memory B Cells | At months 30 and 42 after the first vaccination | As determined by Enzyme-Linked ImmunoSpot (ELISPOT) assay. |
| Frequencies of VZV-specific Memory B Cells | At months 30 and 42 after the first vaccination | As determined by Enzyme-Linked ImmunoSpot (ELISPOT) assay. |
| 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. | At Months 30 and 42 after the first vaccination | 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. |
| Number of Subjects With Clinically Diagnosed Herpes Zoster (HZ) Episodes | From last primary study visit (Month 12) to study end at Month 42 after the first vaccination. | This assay tabulated the number of subjects with clinically diagnosed HZ episodes, defined as any cutaneous HZ-like rash. |
| Number of Subjects With Any Serious Adverse Events (SAEs) | From Month 30 to study end Month 42 after the first vaccination | 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. |
| Anti-gE Antibody (Ab) Concentrations | At months 30 and 42 after the first vaccination | As determined by the Enzyme-Linked Immunosorbent Assay (ELISA) and expressed as ELISA units per milliliter (EL.U/mL). |
| Anti-VZV Ab Concentrations | At months 30 and 42 after the first vaccination | As determined by the Enzyme-Linked Immunosorbent Assay (ELISA) and expressed as ELISA units per milliliter (EL.U/mL). |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GSK1437173A 18-30 Years Old Group Subjects aged 18 to 30 years old primed with 2 doses GSK1437173A vaccine. | 4 |
| GSK1437173A 50-70 Years Old Group Subjects aged 50 to 70 years old primed with 2 doses GSK1437173A vaccine. | 30 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Month 30 (109671 Study) | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | GSK1437173A 18-30 Years Old Group | GSK1437173A 50-70 Years Old Group | Total |
|---|---|---|---|
| Age, Continuous | 22.7 Years STANDARD_DEVIATION 3.79 | 56.0 Years STANDARD_DEVIATION 4.59 | 51.6 Years STANDARD_DEVIATION 12.28 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 3 Participants | 23 Participants | 19 Participants |
| Sex: Female, Male Male | 0 Participants | 7 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 30 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 4 | 0 / 30 |
Outcome results
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.
Time frame: At Month 42 after the first vaccination
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GSK1437173A 18-30 Years Old Group | Frequencies of Glycoprotein E (gE)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). | NA gE-specific CD4 cells/million CD4 cells | — |
| GSK1437173A 50-70 Years Old Group | Frequencies of Glycoprotein E (gE)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). | 899.8 gE-specific CD4 cells/million CD4 cells | Standard Deviation 844.4 |
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.
Time frame: At Month 30 after the first vaccination.
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GSK1437173A 18-30 Years Old Group | 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). | NA gE-specific CD4 cells/million CD4 cells | — |
| GSK1437173A 50-70 Years Old Group | 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). | 1184.7 gE-specific CD4 cells/million CD4 cells | Standard Deviation 925.8 |
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.
Time frame: At Month 30 after the first vaccination
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GSK1437173A 18-30 Years Old Group | 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). | NA VZV-specific CD4 cells/million CD4 cells | — |
| GSK1437173A 50-70 Years Old Group | 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). | 707.4 VZV-specific CD4 cells/million CD4 cells | Standard Deviation 533.1 |
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.
Time frame: At Month 42 after the first vaccination
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GSK1437173A 18-30 Years Old Group | 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). | NA VZV-specific CD4 cells/million CD4 cells | — |
| GSK1437173A 50-70 Years Old Group | 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). | 723.8 VZV-specific CD4 cells/million CD4 cells | Standard Deviation 816.4 |
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).
Time frame: At months 30 and 42 after the first vaccination
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1437173A 18-30 Years Old Group | Anti-gE Antibody (Ab) Concentrations | At Month 30 | 4008.9 EL.U/mL |
| GSK1437173A 18-30 Years Old Group | Anti-gE Antibody (Ab) Concentrations | At Month 42 | 3662.2 EL.U/mL |
| GSK1437173A 50-70 Years Old Group | Anti-gE Antibody (Ab) Concentrations | At Month 30 | 3390.1 EL.U/mL |
| GSK1437173A 50-70 Years Old Group | Anti-gE Antibody (Ab) Concentrations | At Month 42 | 2413.1 EL.U/mL |
Secondary
Anti-VZV Ab Concentrations
As determined by the Enzyme-Linked Immunosorbent Assay (ELISA) and expressed as ELISA units per milliliter (EL.U/mL).
Time frame: At months 30 and 42 after the first vaccination
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1437173A 18-30 Years Old Group | Anti-VZV Ab Concentrations | At Month 30 | 5341.8 EL.U/mL |
| GSK1437173A 18-30 Years Old Group | Anti-VZV Ab Concentrations | At Month 42 | 3988.2 EL.U/mL |
| GSK1437173A 50-70 Years Old Group | Anti-VZV Ab Concentrations | At Month 30 | 4049.3 EL.U/mL |
| GSK1437173A 50-70 Years Old Group | Anti-VZV Ab Concentrations | At Month 42 | 2683.3 EL.U/mL |
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.
Time frame: At Months 30 and 42 after the first vaccination
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1437173A 18-30 Years Old Group | 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. | gE, IL-2 and IFN-γ/TNF-α/CD40L, Month 30 | NA CD4 cells/million T-cells | — |
| GSK1437173A 18-30 Years Old Group | 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. | gE, IFN-γ and IL-2/TNF-α/CD40L, Month 30 | NA CD4 cells/million T-cells | — |
| GSK1437173A 18-30 Years Old Group | 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. | gE, TNF-α and IFN-γ/IL-2/CD40L, Month 30 | NA CD4 cells/million T-cells | — |
| GSK1437173A 18-30 Years Old Group | 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. | gE, CD40L and IFN-γ/IL-2/TNF-α, Month 30 | NA CD4 cells/million T-cells | — |
| GSK1437173A 18-30 Years Old Group | 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. | gE, IL-2 and IFN-γ/TNF-α/CD40L, Month 42 | NA CD4 cells/million T-cells | — |
| GSK1437173A 18-30 Years Old Group | 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. | gE, IFN-γ and IL-2/TNF-α/CD40L, Month 42 | NA CD4 cells/million T-cells | — |
| GSK1437173A 18-30 Years Old Group | 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. | gE, TNF-α and IFN-γ/IL-2/CD40L, Month 42 | NA CD4 cells/million T-cells | — |
| GSK1437173A 18-30 Years Old Group | 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. | gE, CD40L and IFN-γ/IL-2/TNF-α, Month 42 | NA CD4 cells/million T-cells | — |
| GSK1437173A 18-30 Years Old Group | 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. | VZV, IL-2 and IFN-γ/TNF-α/CD40L, Month 30 | NA CD4 cells/million T-cells | — |
| GSK1437173A 18-30 Years Old Group | 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. | VZV, IFN-γ and IL-2/TNF-α/CD40L, Month 30 | NA CD4 cells/million T-cells | — |
| GSK1437173A 18-30 Years Old Group | 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. | VZV, TNF-α and IFN-γ/IL-2/CD40L, Month 30 | NA CD4 cells/million T-cells | — |
| GSK1437173A 18-30 Years Old Group | 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. | VZV, CD40L and IFN-γ/IL-2/TNF-α, Month 30 | NA CD4 cells/million T-cells | — |
| GSK1437173A 18-30 Years Old Group | 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. | VZV, IL-2 and IFN-γ/TNF-α/CD40L, Month 42 | NA CD4 cells/million T-cells | — |
| GSK1437173A 18-30 Years Old Group | 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. | VZV, IFN-γ and IL-2/TNF-α/CD40L, Month 42 | NA CD4 cells/million T-cells | — |
| GSK1437173A 18-30 Years Old Group | 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. | VZV, TNF-α and IFN-γ/IL-2/CD40L, Month 42 | NA CD4 cells/million T-cells | — |
| GSK1437173A 18-30 Years Old Group | 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. | VZV, CD40L and IFN-γ/IL-2/TNF-α, Month 42 | NA CD4 cells/million T-cells | — |
| GSK1437173A 50-70 Years Old Group | 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. | VZV, CD40L and IFN-γ/IL-2/TNF-α, Month 42 | 617.3 CD4 cells/million T-cells | Standard Deviation 743.6 |
| GSK1437173A 50-70 Years Old Group | 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. | gE, IL-2 and IFN-γ/TNF-α/CD40L, Month 30 | 1144.8 CD4 cells/million T-cells | Standard Deviation 912.2 |
| GSK1437173A 50-70 Years Old Group | 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. | VZV, IL-2 and IFN-γ/TNF-α/CD40L, Month 30 | 654.2 CD4 cells/million T-cells | Standard Deviation 494 |
| GSK1437173A 50-70 Years Old Group | 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. | gE, IFN-γ and IL-2/TNF-α/CD40L, Month 30 | 574.2 CD4 cells/million T-cells | Standard Deviation 402.7 |
| GSK1437173A 50-70 Years Old Group | 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. | VZV, IL-2 and IFN-γ/TNF-α/CD40L, Month 42 | 631.5 CD4 cells/million T-cells | Standard Deviation 694.6 |
| GSK1437173A 50-70 Years Old Group | 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. | gE, TNF-α and IFN-γ/IL-2/CD40L, Month 30 | 806.4 CD4 cells/million T-cells | Standard Deviation 721.1 |
| GSK1437173A 50-70 Years Old Group | 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. | VZV, IFN-γ and IL-2/TNF-α/CD40L, Month 30 | 467.1 CD4 cells/million T-cells | Standard Deviation 349.9 |
| GSK1437173A 50-70 Years Old Group | 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. | gE, CD40L and IFN-γ/IL-2/TNF-α, Month 30 | 1173.8 CD4 cells/million T-cells | Standard Deviation 918.6 |
| GSK1437173A 50-70 Years Old Group | 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. | VZV, TNF-α and IFN-γ/IL-2/CD40L, Month 42 | 556.1 CD4 cells/million T-cells | Standard Deviation 629.9 |
| GSK1437173A 50-70 Years Old Group | 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. | gE, IL-2 and IFN-γ/TNF-α/CD40L, Month 42 | 896.9 CD4 cells/million T-cells | Standard Deviation 822.9 |
| GSK1437173A 50-70 Years Old Group | 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. | VZV, TNF-α and IFN-γ/IL-2/CD40L, Month 30 | 528.0 CD4 cells/million T-cells | Standard Deviation 417.3 |
| GSK1437173A 50-70 Years Old Group | 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. | gE, IFN-γ and IL-2/TNF-α/CD40L, Month 42 | 531.5 CD4 cells/million T-cells | Standard Deviation 533.3 |
| GSK1437173A 50-70 Years Old Group | 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. | VZV, IFN-γ and IL-2/TNF-α/CD40L, Month 42 | 542.0 CD4 cells/million T-cells | Standard Deviation 682.1 |
| GSK1437173A 50-70 Years Old Group | 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. | gE, TNF-α and IFN-γ/IL-2/CD40L, Month 42 | 506.5 CD4 cells/million T-cells | Standard Deviation 550.8 |
| GSK1437173A 50-70 Years Old Group | 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. | VZV, CD40L and IFN-γ/IL-2/TNF-α, Month 30 | 694.2 CD4 cells/million T-cells | Standard Deviation 518.3 |
| GSK1437173A 50-70 Years Old Group | 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. | gE, CD40L and IFN-γ/IL-2/TNF-α, Month 42 | 855.5 CD4 cells/million T-cells | Standard Deviation 769.7 |
Secondary
Frequencies of gE-specific Memory B Cells
As determined by Enzyme-Linked ImmunoSpot (ELISPOT) assay.
Time frame: At months 30 and 42 after the first vaccination
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1437173A 18-30 Years Old Group | Frequencies of gE-specific Memory B Cells | At Month 30 | NA gE-specific B-cells/million B-cells | — |
| GSK1437173A 18-30 Years Old Group | Frequencies of gE-specific Memory B Cells | At Month 42 | NA gE-specific B-cells/million B-cells | — |
| GSK1437173A 50-70 Years Old Group | Frequencies of gE-specific Memory B Cells | At Month 30 | 3614.2 gE-specific B-cells/million B-cells | Standard Deviation 2389.8 |
| GSK1437173A 50-70 Years Old Group | Frequencies of gE-specific Memory B Cells | At Month 42 | 2696.1 gE-specific B-cells/million B-cells | Standard Deviation 2644 |
Secondary
Frequencies of VZV-specific Memory B Cells
As determined by Enzyme-Linked ImmunoSpot (ELISPOT) assay.
Time frame: At months 30 and 42 after the first vaccination
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1437173A 18-30 Years Old Group | Frequencies of VZV-specific Memory B Cells | At Month 30 | NA VZV-specific B-cells/million B-cells | — |
| GSK1437173A 18-30 Years Old Group | Frequencies of VZV-specific Memory B Cells | At Month 42 | NA VZV-specific B-cells/million B-cells | — |
| GSK1437173A 50-70 Years Old Group | Frequencies of VZV-specific Memory B Cells | At Month 30 | 4853.8 VZV-specific B-cells/million B-cells | Standard Deviation 3362.1 |
| GSK1437173A 50-70 Years Old Group | Frequencies of VZV-specific Memory B Cells | At Month 42 | 3488.1 VZV-specific B-cells/million B-cells | Standard Deviation 2689.1 |
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.
Time frame: From Month 30 to study end Month 42 after the first vaccination
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1437173A 18-30 Years Old Group | Number of Subjects With Any Serious Adverse Events (SAEs) | 0 Participants |
| GSK1437173A 50-70 Years Old Group | Number of Subjects With Any Serious Adverse Events (SAEs) | 0 Participants |
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.
Time frame: From last primary study visit (Month 12) to study end at Month 42 after the first vaccination.
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1437173A 18-30 Years Old Group | Number of Subjects With Clinically Diagnosed Herpes Zoster (HZ) Episodes | 0 Participants |
| GSK1437173A 50-70 Years Old Group | Number of Subjects With Clinically Diagnosed Herpes Zoster (HZ) Episodes | 0 Participants |