Herpes Zoster
Conditions
Keywords
Herpes Zoster, vaccine, safety, immunogenicity
Brief summary
The subjects included in this study are subjects that participated in study NCT00434577. These subjects were vaccinated with the candidate Herpes Zoster (HZ) vaccine at Month 0 and Month 2 and were then followed at Month 12, Month 24 and Month 36 (study NCT00434577) for safety and immunogenicity. This long term follow up study (ZOSTER-024 \[114825\]) will evaluate immune responses to and safety of the previously administered candidate HZ vaccine at Months 48, 60 and 72. The study visits will be scheduled at approximately one year intervals after the first visit in ZOSTER-024. Blood samples for the evaluation of cellular and humoral immunity will be taken from all subjects at each visit. Information on safety and the occurrence of HZ will also be collected during these visits.
Interventions
PROCEDUREBlood sample
Blood sample will be collected at Month 48, Month 60 and Month 72
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes can and will comply with the requirements of the protocol * Previous participation in study NCT00434577 as a member of the intermediate dose active vaccine group * Written informed consent obtained from the subject
Exclusion criteria
* Having participated in another study at any time after NCT00434577 study end in which the subject was exposed to an investigational or non-investigational product or; concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product * Administration of immunoglobulins and/or any blood products within the 3 months preceding the first blood draw * Having received a vaccine containing some vaccine components, any time after study end of study NCT00434577 * Having received a vaccine against HZ any time after study end of study NCT00434577 * Subject who did not receive a complete vaccination course of 2 doses of the intermediate dose active vaccine in study NCT00434577
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells | Month 48 | -Frequencies of CD4 T cells with antigen-specific Interferon gamma (IFN-γ) and/or Interleukin-2 (IL-2) and/or Tumour Necrosis Factor alpha (TNF-α) and/or CD40 Ligand (CD40L) secretion/expression to glycoprotein E (gE) and Varicella Zoster Virus (VZV) as determined by Intracellular Cytokine Staining (ICS) |
| Antigen-specific Antibody (Ab) Concentrations | Month 48 | -Anti-Glicoprotein E (Anti-gE) and anti-VZV Ab concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any Fatal SAEs | Month 48 to Month 72 | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects With Any Suspected Cases of HZ Episodes | Month 48 to Month 72 | — |
| Number of Subjects With Any Serious Adverse Events (SAEs) Related to the Study Participation | Month 48 to Month 72 | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects and Relationship to Vaccination of Any Potential Immune Mediated Diseases (pIMDs) Following Participation in 108494 Study and Its Follow-ups (108516, 108518 and 108520) and Not Already Documented | Month 48 to Month 72 | — |
| Number of Subjects With Any Suspected Cases of HZ Episodes Following Participation in 108494 Study and Its Follow-ups (108516, 108518 and 108520) and Not Already Documented | Month 48 to Month 72 | — |
| Number of Subjects With Any SAEs Related to Previous Vaccination and Not Already Documented | Month 0 to Month 72 | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
Countries
Czechia, Germany, Netherlands, Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GSK1437173A Group Subjects who received 2 doses of HZ vaccine in the intermediate dose study group in study 108494 (NCT00434577). No treatment was given in this current study (NCT01295320). | 129 |
| Total | 129 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Subject was bedridden | 1 |
| Overall Study | Unable to travel | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | GSK1437173A Group |
|---|---|
| Age, Continuous | 72.8 Years STANDARD_DEVIATION 4.96 |
| Race/Ethnicity, Customized African Heritage/African American | 1 Participants |
| Race/Ethnicity, Customized White - Caucasian/European Heritage | 128 Participants |
| Sex: Female, Male Female | 78 Participants |
| Sex: Female, Male Male | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 129 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 4 / 129 |
Outcome results
Primary
Antigen-specific Antibody (Ab) Concentrations
-Anti-Glicoprotein E (Anti-gE) and anti-VZV Ab concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA)
Time frame: Month 48
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol and with no elimination criteria during the study).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1437173A Group | Antigen-specific Antibody (Ab) Concentrations | anti-gE | 9093.2 mIU/ml |
| GSK1437173A Group | Antigen-specific Antibody (Ab) Concentrations | anti-VZV | 2869.9 mIU/ml |
Primary
Antigen-specific Antibody (Ab) Concentrations
-Anti-Glicoprotein E (Anti-gE) and anti-VZV Ab concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA)
Time frame: Month 60
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol and with no elimination criteria during the study).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1437173A Group | Antigen-specific Antibody (Ab) Concentrations | anti-gE | 8831.3 mIU/ml |
| GSK1437173A Group | Antigen-specific Antibody (Ab) Concentrations | anti-VZV | 2890.0 mIU/ml |
Primary
Antigen-specific Antibody (Ab) Concentrations
-Anti-Glicoprotein E (Anti-gE) and anti-VZV Ab concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA)
Time frame: Month 72
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol and with no elimination criteria during the study).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1437173A Group | Antigen-specific Antibody (Ab) Concentrations | anti-gE | 7711.3 mIU/ml |
| GSK1437173A Group | Antigen-specific Antibody (Ab) Concentrations | anti-VZV | 2933.4 mIU/ml |
Primary
Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells
-Frequencies of CD4 T cells with antigen-specific Interferon gamma (IFN-γ) and/or Interleukin-2 (IL-2) and/or Tumour Necrosis Factor alpha (TNF-α) and/or CD40 Ligand (CD40L) secretion/expression to glycoprotein E (gE) and Varicella Zoster Virus (VZV) as determined by Intracellular Cytokine Staining (ICS)
Time frame: Month 48
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol and with no elimination criteria during the study).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1437173A Group | Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells | CD4[2+] anti-gE specific cells | 726.19 cells/million T-cells | Standard Deviation 1051.77 |
| GSK1437173A Group | Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells | CD4[2+] anti-VZV specific cells | 567.52 cells/million T-cells | Standard Deviation 531.31 |
Primary
Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells
Frequencies of CD4 T cells with antigen-specific Interferon gamma (IFN-γ) and/or Interleukin-2 (IL-2) and/or Tumour Necrosis Factor alpha (TNF-α) and/or CD40 Ligand (CD40L) secretion/expression to glycoprotein E (gE) and Varicella Zoster Virus (VZV) as determined by Intracellular Cytokine Staining (ICS)
Time frame: Month 60
Population: The analysis was base don the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol and with no elimination criteria during the study).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1437173A Group | Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells | CD4[2+] anti-gE cells | 744.43 cells/million T-cells | Standard Deviation 810.14 |
| GSK1437173A Group | Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells | CD4[2+] anti-VZV cells | 697.75 cells/million T-cells | Standard Deviation 550.17 |
Primary
Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells
Frequencies of CD4 T cells with antigen-specific Interferon gamma (IFN-γ) and/or Interleukin-2 (IL-2) and/or Tumour Necrosis Factor alpha (TNF-α) and/or CD40 Ligand (CD40L) secretion/expression to glycoprotein E (gE) and Varicella Zoster Virus (VZV) as determined by Intracellular Cytokine Staining (ICS)
Time frame: Month 72
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol and with no elimination criteria during the study).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1437173A Group | Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells | CD4[2+] anti-gE cells | 630.76 cells/million T-cells | Standard Deviation 548.14 |
| GSK1437173A Group | Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells | CD4[2+] anti-VZV cells | 473.06 cells/million T-cells | Standard Deviation 449.71 |
Secondary
Number of Subjects and Relationship to Vaccination of Any Potential Immune Mediated Diseases (pIMDs) Following Participation in 108494 Study and Its Follow-ups (108516, 108518 and 108520) and Not Already Documented
Time frame: Month 48 to Month 72
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Group | Number of Subjects and Relationship to Vaccination of Any Potential Immune Mediated Diseases (pIMDs) Following Participation in 108494 Study and Its Follow-ups (108516, 108518 and 108520) and Not Already Documented | Any pIMDs | 1 Participants |
| GSK1437173A Group | Number of Subjects and Relationship to Vaccination of Any Potential Immune Mediated Diseases (pIMDs) Following Participation in 108494 Study and Its Follow-ups (108516, 108518 and 108520) and Not Already Documented | Related pIMDs | 0 Participants |
Secondary
Number of Subjects With Any Fatal SAEs
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: Month 48 to Month 72
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1437173A Group | Number of Subjects With Any Fatal SAEs | 2 Participants |
Secondary
Number of Subjects With Any SAEs Related to Previous Vaccination and Not Already Documented
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: Month 0 to Month 72
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1437173A Group | Number of Subjects With Any SAEs Related to Previous Vaccination and Not Already Documented | 0 Participants |
Secondary
Number of Subjects With Any Serious Adverse Events (SAEs) Related to the Study Participation
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: Month 48 to Month 72
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1437173A Group | Number of Subjects With Any Serious Adverse Events (SAEs) Related to the Study Participation | 2 Participants |
Secondary
Number of Subjects With Any Suspected Cases of HZ Episodes
Time frame: Month 48 to Month 72
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1437173A Group | Number of Subjects With Any Suspected Cases of HZ Episodes | 1 Participants |
Secondary
Number of Subjects With Any Suspected Cases of HZ Episodes Following Participation in 108494 Study and Its Follow-ups (108516, 108518 and 108520) and Not Already Documented
Time frame: Month 48 to Month 72
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1437173A Group | Number of Subjects With Any Suspected Cases of HZ Episodes Following Participation in 108494 Study and Its Follow-ups (108516, 108518 and 108520) and Not Already Documented | 0 Participants |