Trial Outcomes & Findings for Study of Long Term Immune Responses and Safety of the GSK Herpes Zoster Vaccine in Healthy Subjects (NCT NCT01295320)

NCT ID: NCT01295320

Last Updated: 2017-11-27

Results Overview

-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)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 129 participants
• Primary outcome timeframe: Month 48
• Results posted on: 2017-11-27

Participant Flow

Participant milestones

Measure	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).
Overall Study STARTED	129
Overall Study COMPLETED	119
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Measure	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).
Overall Study Adverse Event	2
Overall Study Lost to Follow-up	4
Overall Study Withdrawal by Subject	2
Overall Study Subject was bedridden	1
Overall Study Unable to travel	1

Baseline Characteristics

Study of Long Term Immune Responses and Safety of the GSK Herpes Zoster Vaccine in Healthy Subjects

Baseline characteristics by cohort

Measure	GSK1437173A Group n=129 Participants 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).
Age, Continuous	72.8 Years STANDARD_DEVIATION 4.96 • n=5 Participants
Sex: Female, Male Female	78 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants
Race/Ethnicity, Customized White - Caucasian/European Heritage	128 Participants n=5 Participants
Race/Ethnicity, Customized African Heritage/African American	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

-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)

Outcome measures

Measure	GSK1437173A Group n=126 Participants 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).
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
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 outcome

Timeframe: 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).

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)

Outcome measures

Measure	GSK1437173A Group n=126 Participants 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).
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
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 outcome

Timeframe: 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).

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)

Outcome measures

Measure	GSK1437173A Group n=126 Participants 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).
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
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

PRIMARY outcome

Timeframe: 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).

-Anti-Glicoprotein E (Anti-gE) and anti-VZV Ab concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA)

Outcome measures

Measure	GSK1437173A Group n=126 Participants 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).
Antigen-specific Antibody (Ab) Concentrations anti-gE	9093.2 mIU/ml Interval 8041.3 to 10282.6
Antigen-specific Antibody (Ab) Concentrations anti-VZV	2869.9 mIU/ml Interval 2565.5 to 3210.5

PRIMARY outcome

Timeframe: 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).

-Anti-Glicoprotein E (Anti-gE) and anti-VZV Ab concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA)

Outcome measures

Measure	GSK1437173A Group n=126 Participants 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).
Antigen-specific Antibody (Ab) Concentrations anti-gE	8831.3 mIU/ml Interval 7767.2 to 10041.3
Antigen-specific Antibody (Ab) Concentrations anti-VZV	2890.0 mIU/ml Interval 2536.0 to 3293.4

PRIMARY outcome

Timeframe: 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).

-Anti-Glicoprotein E (Anti-gE) and anti-VZV Ab concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA)

Outcome measures

Measure	GSK1437173A Group n=126 Participants 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).
Antigen-specific Antibody (Ab) Concentrations anti-gE	7711.3 mIU/ml Interval 6810.8 to 8730.9
Antigen-specific Antibody (Ab) Concentrations anti-VZV	2933.4 mIU/ml Interval 2577.7 to 3338.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	GSK1437173A Group n=129 Participants 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).
Number of Subjects With Any Serious Adverse Events (SAEs) Related to the Study Participation	2 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	GSK1437173A Group n=129 Participants 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).
Number of Subjects With Any SAEs Related to Previous Vaccination and Not Already Documented	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	GSK1437173A Group n=129 Participants 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).
Number of Subjects With Any Fatal SAEs	2 Participants

SECONDARY outcome

Timeframe: Month 48 to Month 72

Outcome measures

Measure	GSK1437173A Group n=129 Participants 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).
Number of Subjects With Any Suspected Cases of HZ Episodes	1 Participants

SECONDARY outcome

Timeframe: Month 48 to Month 72

Outcome measures

Measure	GSK1437173A Group n=129 Participants 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).
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

SECONDARY outcome

Timeframe: Month 48 to Month 72

Outcome measures

Measure	GSK1437173A Group n=129 Participants 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).
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
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

Adverse Events

GSK1437173A Group

Serious events: 4 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Measure	GSK1437173A Group n=129 participants at risk 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).
Blood and lymphatic system disorders Anaemia	0.78% 1/129 • SAEs: Month 0 to Month 72 No Frequent Adverse events were collected during this study.
Gastrointestinal disorders Crohn's disease	0.78% 1/129 • SAEs: Month 0 to Month 72 No Frequent Adverse events were collected during this study.
Vascular disorders Circulatory collapse	0.78% 1/129 • SAEs: Month 0 to Month 72 No Frequent Adverse events were collected during this study.
Gastrointestinal disorders Death	0.78% 1/129 • SAEs: Month 0 to Month 72 No Frequent Adverse events were collected during this study.

Other adverse events

Adverse event data not reported

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER