A Study to Test GlaxoSmithKline's (GSK) Herpes Zoster (HZ) Subunit Vaccine's Long-term Immune Response in Previously Vaccinated Kidney Transplant Adults and Then to Test if 2 Additional Doses of the Vaccine Are Safe and Able to Generate an Immune Response

Long-term Immunogenicity Study of Herpes Zoster Subunit Vaccine (GSK1437173A) and Immunogenicity and Safety Assessment of Revaccination With Two Additional Doses in Adults With Renal Transplant From Study ZOSTER-041

The purpose of this study was to evaluate the long-term immune responses to the Herpes Zoster subunit (HZ/su) vaccine as well as safety up to 7 years after the 2-dose primary vaccination course from study ZOSTER-041 (NCT02058589). This study also assessed immune responses as well as safety after revaccination with 2 additional doses of the HZ/su administered at 6 to 8 years after the 2-dose primary vaccination course.

Study Overview

• Status: Active, not recruiting
• Conditions: Herpes Zoster
• Intervention / Treatment: Biological: HZ/su vaccine (GSK1437173A)

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, 1090
    • GSK Investigational Site
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • GSK Investigational Site
    • Toronto, Ontario, Canada, M5G 2N2
      • GSK Investigational Site
• Finland
  • Helsinki, Finland, 00029
    • GSK Investigational Site
• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 137-701
    • GSK Investigational Site
• Panama
  • Panama, Panama, 1001
    • GSK Investigational Site
• Spain
  • Barcelona, Spain, 08036
    • GSK Investigational Site
  • Barcelona, Spain, 08035
    • GSK Investigational Site
  • Hospitalet de Llobregat, Spain, 08907
    • GSK Investigational Site
  • Madrid, Spain, 28040
    • GSK Investigational Site
  • Madrid, Spain, 28034
    • GSK Investigational Site
  • Santander, Spain, 39008
    • GSK Investigational Site
  • Sevilla, Spain, 41013
    • GSK Investigational Site
• Taiwan
  • Taoyuan, Taiwan, 333
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Inclusion criteria for enrolment

  • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol or/and subjects' Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
  • Written informed consent obtained from the subject/LAR(s) of the subject prior to performance of any study-specific procedure.
  • Subjects who previously participated in study ZOSTER-041 and completed the full 2 dose HZ/su primary vaccination course.

• Inclusion criteria for revaccination

  • Subjects receiving maintenance CIS therapy for the prevention of allograft rejection for a minimum of one month prior to the first revaccination.
  • Subjects without an episode of allograft rejection within 90 days prior to the first revaccination visit.
  • Female subjects of non-childbearing potential may be revaccinated. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.
  • Female subjects of childbearing potential may be revaccinated, if the subject:
• has practiced adequate contraception for 30 days prior to revaccination, and
• has a negative pregnancy test on the day of revaccination, and
• has agreed to continue adequate contraception up to 2 months after completion of the revaccination series.

Exclusion Criteria:

Exclusion criteria for enrolment Medical conditions

• Vaccination against HZ since completion of study ZOSTER-041.
• Significant underlying illness that, in the opinion of the investigator, is expected to prevent completion of the study.
• Any other condition that, in the opinion of the investigator, would interfere with the evaluations required by the study.

Prior/Concurrent clinical study experience

• Concurrently participating in another interventional vaccine or immunosuppressive clinical study, in which the subject is exposed to an investigational or a non-investigational vaccine/product (drug) at any time during the ZOSTER-073 study.

Exclusion criteria for revaccination Medical conditions

• History of confirmed HZ within one year before revaccination visit (Visit 3).
• More than one organ transplanted.
• Any additional confirmed or suspected immunosuppressive or immunodeficient condition.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
• Any other condition that, in the opinion of the investigator, would interfere with the evaluations required by the study or make vaccination unsafe.

Prior/Concomitant therapy

• Administration or planned administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the first revaccination dose of study vaccine and ending at Visit 5 (Month 26).
• Use of anti-CD20 or other B-cell monoclonal antibody agents as maintenance and/or therapeutic immunosuppressive therapy for the prevention of allograft rejection within 9 months of first revaccination dose of study vaccine.
• Evidence or high suspicion, in the opinion of the investigator, of noncompliance or nonadherence to use of maintenance immunosuppressive therapies.
• Planned administration/administration of a live vaccine in the period starting 30 days before the first dose and ending 30 days after the last dose of study vaccine administration.
• Planned administration/administration of a non-replicating or subunit vaccine, not foreseen by the study protocol, in the period starting 8 days before and ending 30 days after each dose of study vaccine.

Other exclusion criteria for revaccination

• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions up to 2 months post-revaccination Dose 2.
• Any condition which, in the judgment of the investigator, would make intramuscular injection unsafe.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: HZ/su Group; Eligible adult participants with renal transplant taking daily chronic immunosuppressive therapy who had a complete 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study. 47 of these participants further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of the current ZOSTER-073 (NCT04176939) study, first dose at Month 24 and second dose at Month 25.

Biological: HZ/su vaccine (GSK1437173A); 2 intramuscular (IM) doses of the HZ/su vaccine administered - first dose at Month 24 and second dose at Month 25.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-glycoprotein E (Anti-gE) Antibody Concentrations in the Long Term Follow Up (LTFU) Phase of the Current ZOSTER-073 Study	Anti-gE antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in milli-international units per milliliter (mIU/mL). As per Protocol, the time points defined for this endpoint were Day 1, Month 12 and Month 24. Since the interval between the end of ZOSTER-041 and the start of ZOSTER-073 studies varied per participant, the first ZOSTER-073 visit (Day 1) may correspond to Year 4, Year 5, or Year 6 post-primary vaccination in ZOSTER-041. The same applies to Month 12, and Month 24 visits, depending on when the participant entered the ZOSTER-073 study. In order to make more meaningful interpretations about persistence of immunogenicity, the ZOSTER-073 visits in the LTFU phase (for both revaccinated and non-revaccinated participants) were displayed in terms of time since ZOSTER-041 primary vaccination, presented in 1-year intervals (i.e., from 3.5 up to less than 4.5 years post-primary vaccination Dose 2).	From 3.5 up to less than 4.5 years post-primary vaccination Dose 2 (administered at Month 1 in ZOSTER-041 study)
Anti-gE Antibody Concentrations in the LTFU Phase of the Current ZOSTER-073 Study	Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in mIU/mL. As per Protocol, the time points defined for this endpoint were Day 1, Month 12 and Month 24. Since the interval between the end of ZOSTER-041 and the start of ZOSTER-073 studies varied per participant, the first ZOSTER-073 visit (Day 1) may correspond to Year 4, Year 5, or Year 6 post-primary vaccination in ZOSTER-041. The same applies to Month 12, and Month 24 visits, depending on when the participant entered the ZOSTER-073 study. In order to make more meaningful interpretations about persistence of immunogenicity, the ZOSTER-073 visits in the LTFU phase (for both revaccinated and non-revaccinated participants) were displayed in terms of time since ZOSTER-041 primary vaccination, presented in 1-year intervals (i.e., from 4.5 up to less than 5.5 years post-primary vaccination Dose 2).	From 4.5 up to less than 5.5 years post-primary vaccination Dose 2 (administered at Month 1 in ZOSTER-041 study)
Anti-gE Antibody Concentrations in the LTFU Phase of the Current ZOSTER-073 Study	Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in mIU/mL. As per Protocol, the time points defined for this endpoint were Day 1, Month 12 and Month 24. Since the interval between the end of ZOSTER-041 and the start of ZOSTER-073 studies varied per participant, the first ZOSTER-073 visit (Day 1) may correspond to Year 4, Year 5, or Year 6 post-primary vaccination in ZOSTER-041. The same applies to Month 12, and Month 24 visits, depending on when the participant entered the ZOSTER-073 study. In order to make more meaningful interpretations about persistence of immunogenicity, the ZOSTER-073 visits in the LTFU phase (for both revaccinated and non-revaccinated participants) were displayed in terms of time since ZOSTER-041 primary vaccination, presented in 1-year intervals (i.e., from 5.5 up to less than 6.5 years post-primary vaccination Dose 2).	From 5.5 up to less than 6.5 years post-primary vaccination Dose 2 (administered at Month 1 in ZOSTER-041 study)
Anti-gE Antibody Concentrations in the LTFU Phase of the Current ZOSTER-073 Study	Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in mIU/mL. As per Protocol, the time points defined for this endpoint were Day 1, Month 12 and Month 24. Since the interval between the end of ZOSTER-041 and the start of ZOSTER-073 studies varied per participant, the first ZOSTER-073 visit (Day 1) may correspond to Year 4, Year 5, or Year 6 post-primary vaccination in ZOSTER-041. The same applies to Month 12, and Month 24 visits, depending on when the participant entered the ZOSTER-073 study. In order to make more meaningful interpretations about persistence of immunogenicity, the ZOSTER-073 visits in the LTFU phase (for both revaccinated and non-revaccinated participants) were displayed in terms of time since ZOSTER-041 primary vaccination, presented in 1-year intervals (i.e., from 6.5 up to less than 7.5 years post-primary vaccination Dose 2).	From 6.5 up to less than 7.5 years post-primary vaccination Dose 2 (administered at Month 1 in ZOSTER-041 study)
Anti-gE Antibody Concentrations in the LTFU Phase of the Current ZOSTER-073 Study	Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in mIU/mL. As per Protocol, the time points defined for this endpoint were Day 1, Month 12 and Month 24. Since the interval between the end of ZOSTER-041 and the start of ZOSTER-073 studies varied per participant, the first ZOSTER-073 visit (Day 1) may correspond to Year 4, Year 5, or Year 6 post-primary vaccination in ZOSTER-041. The same applies to Month 12, and Month 24 visits, depending on when the participant entered the ZOSTER-073 study. In order to make more meaningful interpretations about persistence of immunogenicity, the ZOSTER-073 visits in the LTFU phase (for both revaccinated and non-revaccinated participants) were displayed in terms of time since ZOSTER-041 primary vaccination, presented in 1-year intervals (i.e., from 7.5 up to less than 8.5 years post-primary vaccination Dose 2).	From 7.5 up to less than 8.5 years post-primary vaccination Dose 2 (administered at Month 1 in ZOSTER-041 study)
Anti-gE Antibody Concentrations at Month 24 (Pre-revaccination) in the Revaccination Active Phase of the Current ZOSTER-073 Study	Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in mIU/mL.	At Month 24 (pre-revaccination) in the current ZOSTER-073 study
Anti-gE Antibody Concentrations at Month 25 (1 Month Post-revaccination Dose 1) in the Revaccination Active Phase of the Current ZOSTER-073 Study	Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in mIU/mL.	At Month 25 (1 month post-revaccination Dose 1) in the current ZOSTER-073 study
Anti-gE Antibody Concentrations at Month 26 (1 Month Post-revaccination Dose 2) in the Revaccination Active Phase of the Current ZOSTER-073 Study	Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in mIU/mL.	At Month 26 (1 month post-revaccination Dose 2) in the current ZOSTER-073 study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of gE-specific Cluster of Differentiation 4 (CD4) (2+) T-cells Expressing Two or More Markers From Among IFN-γ, IL-2, TNF-α, and CD40L in the LTFU Phase of the Current ZOSTER-073 Study	Frequency of gE-specific CD4 (2+) T-cells was determined by Intracellular Cytokine Staining and expressed in CD4(2+) T-cells per million cells [CD4(2+) T-cells/million cells]. As per Protocol, the time points defined for this endpoint were Day 1, Month 12 and Month 24. Since the interval between the end of ZOSTER-041 and the start of ZOSTER-073 studies varied per participant, the first ZOSTER-073 visit (Day 1) may correspond to Year 4, Year 5, or Year 6 post-primary vaccination in ZOSTER-041. The same applies to Month 12, and Month 24 visits, depending on when the participant entered the ZOSTER-073 study. In order to make more meaningful interpretations about persistence of immunogenicity, the ZOSTER-073 visits in the LTFU phase (for both revaccinated and non-revaccinated participants) were displayed in terms of time since ZOSTER-041 primary vaccination, presented in 1-year intervals (i.e., from 3.5 up to less than 4.5 years post-primary vaccination Dose 2).	From 3.5 up to less than 4.5 years post-primary vaccination Dose 2 (administered at Month 1 in ZOSTER-041 study)
Frequency of gE-specific CD4 (2+) T-cells Expressing Two or More Markers From Among IFN-γ, IL-2, TNF-α and CD40L in the LTFU Phase of the Current ZOSTER-073 Study	Frequency of gE-specific CD4 (2+) T-cells was determined by Intracellular Cytokine Staining and expressed in CD4(2+) T-cells/million cells. As per Protocol, the time points defined for this endpoint were Day 1, Month 12 and Month 24. Since the interval between the end of ZOSTER-041 and the start of ZOSTER-073 studies varied per participant, the first ZOSTER-073 visit (Day 1) may correspond to Year 4, Year 5, or Year 6 post-primary vaccination in ZOSTER-041. The same applies to Month 12, and Month 24 visits, depending on when the participant entered the ZOSTER-073 study. In order to make more meaningful interpretations about persistence of immunogenicity, the ZOSTER-073 visits in the LTFU phase (for both revaccinated and non-revaccinated participants) were displayed in terms of time since ZOSTER-041 primary vaccination, presented in 1-year intervals (i.e., from 4.5 up to less than 5.5 years post-primary vaccination Dose 2).	From 4.5 up to less than 5.5 years post-primary vaccination Dose 2 (administered at Month 1 in ZOSTER-041 study)
Frequency of gE-specific CD4 (2+) T-cells Expressing Two or More Markers From Among IFN-γ, IL-2, TNF-α and CD40L in the LTFU Phase of the Current ZOSTER-073 Study	Frequency of gE-specific CD4 (2+) T-cells was determined by Intracellular Cytokine Staining and expressed in CD4(2+) T-cells/million cells. As per Protocol, the time points defined for this endpoint were Day 1, Month 12 and Month 24. Since the interval between the end of ZOSTER-041 and the start of ZOSTER-073 studies varied per participant, the first ZOSTER-073 visit (Day 1) may correspond to Year 4, Year 5, or Year 6 post-primary vaccination in ZOSTER-041. The same applies to Month 12, and Month 24 visits, depending on when the participant entered the ZOSTER-073 study. In order to make more meaningful interpretations about persistence of immunogenicity, the ZOSTER-073 visits in the LTFU phase (for both revaccinated and non-revaccinated participants) were displayed in terms of time since ZOSTER-041 primary vaccination, presented in 1-year intervals (i.e., from 5.5 up to less than 6.5 years post-primary vaccination Dose 2).	From 5.5 up to less than 6.5 years post-primary vaccination Dose 2 (administered at Month 1 in ZOSTER-041 study)
Frequency of gE-specific CD4 (2+) T-cells Expressing Two or More Markers From Among IFN-γ, IL-2, TNF-α and CD40L in the LTFU Phase of the Current ZOSTER-073 Study	Frequency of gE-specific CD4 (2+) T-cells was determined by Intracellular Cytokine Staining and expressed in CD4(2+) T-cells/million cells. As per Protocol, the time points defined for this endpoint were Day 1, Month 12 and Month 24. Since the interval between the end of ZOSTER-041 and the start of ZOSTER-073 studies varied per participant, the first ZOSTER-073 visit (Day 1) may correspond to Year 4, Year 5, or Year 6 post-primary vaccination in ZOSTER-041. The same applies to Month 12, and Month 24 visits, depending on when the participant entered the ZOSTER-073 study. In order to make more meaningful interpretations about persistence of immunogenicity, the ZOSTER-073 visits in the LTFU phase (for both revaccinated and non-revaccinated participants) were displayed in terms of time since ZOSTER-041 primary vaccination, presented in 1-year intervals (i.e., from 6.5 up to less than 7.5 years post-primary vaccination Dose 2).	From 6.5 up to less than 7.5 years post-primary vaccination Dose 2 (administered at Month 1 in ZOSTER-041 study)
Frequency of gE-specific CD4 (2+) T-cells Expressing Two or More Markers From Among IFN-γ, IL-2, TNF-α and CD40L in the LTFU Phase of the Current ZOSTER-073 Study	Frequency of gE-specific CD4 (2+) T-cells was determined by Intracellular Cytokine Staining and expressed in CD4(2+) T-cells/million cells. As per Protocol, the time points defined for this endpoint were Day 1, Month 12 and Month 24. Since the interval between the end of ZOSTER-041 and the start of ZOSTER-073 studies varied per participant, the first ZOSTER-073 visit (Day 1) may correspond to Year 4, Year 5, or Year 6 post-primary vaccination in ZOSTER-041. The same applies to Month 12, and Month 24 visits, depending on when the participant entered the ZOSTER-073 study. In order to make more meaningful interpretations about persistence of immunogenicity, the ZOSTER-073 visits in the LTFU phase (for both revaccinated and non-revaccinated participants) were displayed in terms of time since ZOSTER-041 primary vaccination, presented in 1-year intervals (i.e., from 7.5 up to less than 8.5 years post-primary vaccination Dose 2).	From 7.5 up to less than 8.5 years post-primary vaccination Dose 2 (administered at Month 1 in ZOSTER-041 study)
Number of Participants With Serious Adverse Events (SAEs) Related to Primary Vaccination, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study	SAEs assessed included any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. SAEs related to primary vaccination were assessed by the investigator.	From Month 13 (last visit) in ZOSTER-041 primary study up to Month 24 in the current ZOSTER-073 study. Note: Month 24 was pre-revaccination for those participants who were revaccinated.
Number of Participants With Suspected or Confirmed Herpes Zoster (HZ) Episode, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study	A suspected HZ episode was defined as a new unilateral rash accompanied by pain broadly defined to include allodynia, pruritus or other sensations without alternative diagnosis. A confirmed HZ episode was diagnosed by Polymerase Chain Reaction (PCR) or by the HZ Ascertainment Committee (HZAC) determination.	From Month 13 (last visit) in ZOSTER-041 primary study up to Day 1 (first visit) in the current ZOSTER-073 study
Number of Participants With a Confirmed HZ Episode in the LTFU Phase of the Current ZOSTER-073 Study	A confirmed HZ episode was diagnosed by Polymerase Chain Reaction (PCR) or by the HZ Ascertainment Committee (HZAC) determination.	From Day 1 up to Month 24 in the current ZOSTER-073 study. Note: Month 24 was pre-revaccination for those participants who were revaccinated.
Number of Participants With Suspected or Biopsy-proven Allograft Rejections, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study	Suspected or biopsy-proven allograft rejection is defined as an adverse event of specific interest (AESI). Case report form (CRF) will be updated with the biopsies collected in the gap between ZOSTER-041 and ZOSTER-073 studies. Suspected or biopsy-proven allograft rejections data from Month 13 in ZOSTER-041 primary study up to Day 1 in the current ZOSTER-073 study will be provided at the final results disclosure stage.	From Month 13 (last visit) in ZOSTER-041 primary study up to Day 1 (first visit) in the current ZOSTER-073 study
Number of Participants With Biopsy-proven Allograft Rejections in the LTFU Phase of the Current ZOSTER-073 Study	Biopsy-proven allograft rejection is defined as an adverse event of specific interest (AESI).	From Day 1 up to Month 24 in the current ZOSTER-073 study. Note: Month 24 was pre-revaccination for those participants who were revaccinated.
Number of Participants With Allograft Dysfunction Related to Allograft Rejection Episodes, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study	Declining allograft function (allograft dysfunction) was assessed through all clinically obtained serum creatinine values from 2 months prior to an episode of biopsy-proven rejection and up to 2 months after rejection resolution and cessation of high dose of immunosuppressive therapy.	From Month 13 (last visit) in ZOSTER-041 primary study up to Month 24 in the current ZOSTER-073 study. Note: Month 24 was pre-revaccination for those participants who were revaccinated.
Number of Participants With Allograft Dysfunction Related to HZ Episodes, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study	Declining allograft function was assessed through all clinically obtained serum creatinine values from 2 months prior to an episode of HZ and up to 2 months after HZ rash resolution.	From Month 13 (last visit) in ZOSTER-041 primary study up to Month 24 in the current ZOSTER-073 study. Note: Month 24 was pre-revaccination for those participants who were revaccinated.
Frequency of gE-specific CD4(2+) T-cells Expressing Two or More Markers From Among IFN-γ, IL-2, TNF-α, and CD40L at Month 24 (Pre-revaccination) in the Revaccination Active Phase of the Current ZOSTER-073 Study	Frequency of gE-specific CD4 (2+) T-cells was determined by Intracellular Cytokine Staining and expressed in CD4(2+) T-cells/million cells.	At Month 24 (pre-revaccination) in the current ZOSTER-073 study
Frequency of gE-specific CD4(2+) T-cells Expressing Two or More Markers From Among IFN-γ, IL-2, TNF-α, and CD40L at Month 25 (1 Month Post-revaccination Dose 1) in the Revaccination Active Phase of the Current ZOSTER-073 Study	Frequency of gE-specific CD4 (2+) T-cells was determined by Intracellular Cytokine Staining and expressed in CD4(2+) T-cells/million cells.	At Month 25 (1 month post-revaccination Dose 1) in the current ZOSTER-073 study
Frequency of gE-specific CD4(2+) T-cells Expressing Two or More Markers From Among IFN-γ, IL-2, TNF-α, and CD40L at Month 26 (1 Month Post-revaccination Dose 2) in the Revaccination Active Phase of the Current ZOSTER-073 Study	Frequency of gE-specific CD4 (2+) T-cells was determined by Intracellular Cytokine Staining and expressed in CD4(2+) T-cells/million cells.	At Month 26 (1 month post-revaccination Dose 2) in the current ZOSTER-073 study
Anti-gE Antibody Concentrations at Month 37 (12 Months Post-revaccination Dose 2) in the Revaccination Follow-up Phase of the Current ZOSTER-073 Study	Persistence of humoral immunity after the revaccination course will be evaluated in terms of anti-gE antibody concentrations. Anti-gE antibody concentrations will be determined by ELISA and expressed as GMCs in mIU/mL. Anti-gE antibody concentrations for Month 37 time point will be provided at the final results disclosure stage.	At Month 37 (12 months post-revaccination Dose 2) in the current ZOSTER-073 study
Anti-gE Antibody Concentrations at Month 49 (24 Months Post-revaccination Dose 2) in the Revaccination Follow-up Phase of the Current ZOSTER-073 Study	Persistence of humoral immunity after the revaccination course will be evaluated in terms of anti-gE antibody concentrations. Anti-gE antibody concentrations will be determined by ELISA and expressed as GMCs in mIU/mL. Anti-gE antibody concentrations for Month 49 time point will be provided at the final results disclosure stage.	At Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study
Frequency of gE-specific CD4(2+) T-cells Expressing Two or More Markers From Among IFN-γ, IL-2, TNF-α and CD40L at Month 37 (12 Months Post-revaccination Dose 2) in the Revaccination Follow-up Phase of the Current ZOSTER-073 Study	Frequency of gE-specific CD4 (2+) T-cells will be determined by Intracellular Cytokine Staining and expressed in CD4(2+) T-cells/million cells. Frequency of gE-specific CD4 (2+) T-cells for Month 37 time point will be provided at the final results disclosure stage.	At Month 37 (12 months post-revaccination Dose 2) in the current ZOSTER-073 study
Frequency of gE-specific CD4(2+) T-cells Expressing Two or More Markers From Among IFN-γ, IL-2, TNF-α and CD40L at Month 49 (24 Months Post-revaccination Dose 2) in the Revaccination Follow-up Phase of the Current ZOSTER-073 Study	Frequency of gE-specific CD4 (2+) T-cells will be determined by Intracellular Cytokine Staining and expressed in CD4(2+) T-cells/million cells. Frequency of gE-specific CD4 (2+) T-cells for Month 49 time point will be provided at the final results disclosure stage.	At Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study
Percentage of Participants With Any and Grade 3 Solicited Local Adverse Events (AEs) After Each Revaccination in the Revaccination Active Phase of the Current ZOSTER-073 Study	Assessed solicited local AEs included pain, erythema and swelling at injection site. Any AE = occurrence of the symptom regardless of intensity grade. Any erythema/swelling at injection site = redness/swelling at injection site with a diameter larger than (>) 20 millimeters (mm). Grade 3 pain = significant pain at rest, which prevents normal, every day activities. Grade 3 erythema/swelling at injection site = redness/swelling at injection site with a diameter > 100 mm.	Within 7 days after each revaccination dose (administered at Month 24 and Month 25) in the current ZOSTER-073 study
Duration in Days of Solicited Local Adverse Events (AEs) After Each Revaccination in the Revaccination Active Phase of the Current ZOSTER-073 Study	Duration is the number of days in which a participant experienced the AE within the 7-day solicited follow-up period. Assessed solicited local AEs included pain, erythema and swelling at injection site.	Within 7 days after each revaccination dose (administered at Month 24 and Month 25) in the current ZOSTER-073 study
Percentage of Participants With Any, Grade 3 and Related Solicited General Adverse Events (AEs) After Each Revaccination in the Revaccination Active Phase of the Current ZOSTER-073 Study	Assessed solicited general AEs included fatigue, gastrointestinal symptoms (including nausea, vomiting, diarrhea and/or abdominal pain), headache, myalgia, shivering and temperature [higher than or equal (>=) to 38.0 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F) - the preferred route for measuring temperature in this study was oral]. Any AE = occurrence of the symptom regardless of intensity grade. Grade 3 fatigue, gastrointestinal symptoms, headache, myalgia, shivering = symptoms that prevented normal, every day activities. Grade 3 temperature = temperature higher (>) than 39°C. Related fatigue, gastrointestinal symptoms, headache, myalgia, shivering, temperature = symptoms assessed by the investigator as related to the revaccination.	Within 7 days after each revaccination dose (administered at Month 24 and Month 25) in the current ZOSTER-073 study
Duration in Days of Solicited General Adverse Events (AEs) After Each Revaccination in the Revaccination Active Phase of the Current ZOSTER-073 Study	Duration is the number of days in which a participant experienced the AE within the 7-day solicited follow-up period. Assessed solicited general AEs included fatigue, gastrointestinal symptoms (including nausea, vomiting, diarrhea and/or abdominal pain), headache, myalgia, shivering and temperature (>= 38.0 °C/100.4 °F - the preferred route for measuring temperature in this study was oral).	Within 7 days after each revaccination dose (administered at Month 24 and Month 25) in the current ZOSTER-073 study
Percentage of Participants With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Post-revaccination in the Revaccination Active Phase of the Current ZOSTER-073 Study	An unsolicited AE was defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Any AE = occurrence of the symptom regardless of intensity grade or relation to vaccination. Grade 3 AE = symptom that prevented normal, everyday activities. Related AE = symptom assessed by the investigator as related to revaccination.	Within 30 days (across revaccination doses) post-revaccination period in the current ZOSTER-073 study
Percentage of Participants With Any Serious Adverse Events (SAEs) and Fatal SAEs in the Revaccination Active Phase of the Current ZOSTER-073 Study	SAEs assessed included any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any SAE, including fatal SAEs were assessed.	From Month 24 (pre-revaccination) up to Month 26 (1 month post-revaccination Dose 2) in the current ZOSTER-073 study
Percentage of Participants With Any Serious Adverse Events (SAEs) and Fatal SAEs in the Revaccination Follow-up Phase of the Current ZOSTER-073 Study	SAEs assessed will include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. Any SAE, including fatal SAEs will be assessed. Serious adverse events data from Month 26 up to Month 37 will be provided at the final results disclosure stage.	From Month 26 (1 month post-revaccination Dose 2) up to Month 37 (12 months post-revaccination Dose 2) in the current ZOSTER-073 study
Number of Participants With Related Serious Adverse Events (SAEs) and Related-fatal SAEs in the Revaccination Active Phase of the Current ZOSTER-073 Study	SAEs assessed included any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any related-SAE, including related-fatal SAEs were assessed. Related SAE = symptom assessed by the investigator as related to revaccination.	From Month 24 (pre-revaccination) up to Month 26 (1 month post-revaccination Dose 2) in the current ZOSTER-073 study
Number of Participants With Related Serious Adverse Events (SAEs) and Related-fatal SAEs in the Revaccination Follow-up Phase of the Current ZOSTER-073 Study	SAEs assessed will include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. Any related-SAE, including related-fatal SAEs will be assessed. Related SAE = symptom assessed by the investigator as related to revaccination. Serious adverse events data from Month 24 up to Month 49 will be provided at the final results disclosure stage.	From Month 26 (1 month post-revaccination Dose 2) up to Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study
Number of Participants With Any and Related Biopsy-proven Allograft Rejections in the Revaccination Active and Follow-up Phases of the Current ZOSTER-073 Study	Biopsy-proven allograft rejection is defined as an adverse event of special interest (AESI) and is recorded in serious adverse event (SAE) screens, irrespective of the seriousness of the event. Related biopsy proven allograft rejections = biopsy-proven allograft rejections assessed as causally-related to revaccination by the investigator. Biopsy-proven allograft rejections data from Month 24 up to Month 49 will be provided at the final results disclosure stage.	From Month 24 (pre-revaccination) up to Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study
Percentage of Participants With Any and Related Potential Immune-mediated Diseases (pIMDs) in the Revaccination Active and Follow-up Phases of the Current ZOSTER-073 Study	pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. Related pIMDs = pIMDs assessed as causally-related to revaccination by the investigator. pIMDs data from Month 24 up to Month 37 will be provided at the final results disclosure stage.	From Month 24 (pre-revaccination) up to Month 37 (12 months post-revaccination Dose 2) in the current ZOSTER-073 study
Number of Participants With a Confirmed HZ Episode in the Revaccination Active and Follow-up Phases of the Current ZOSTER-073 Study	A confirmed HZ episode is diagnosed by Polymerase Chain Reaction (PCR) or by the HZ Ascertainment Committee (HZAC) determination. Confirmed HZ episode data from Month 24 up to Month 49 will be provided at the final results disclosure stage.	From Month 24 (pre-revaccination) up to Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study
Number of Participants With Allograft Dysfunction Following Revaccination in the Revaccination Active and Follow-up Phases of the Current ZOSTER-073 Study	Declining allograft function will be assessed through all clinically obtained serum creatinine values from 3 months before the first revaccination dose until 3 months after the last revaccination dose. Allograft dysfunction data from Month 24 up to Month 37 will be provided at the final results disclosure stage.	From Month 24 (pre-revaccination) up to Month 37 (12 months post-revaccination Dose 2) in the current ZOSTER-073 study
Number of Participants With Allograft Dysfunction Related to Allograft Rejection in the Revaccination Active and Follow-up Phases of the Current ZOSTER-073 Study	Declining allograft function will be assessed through all clinically obtained serum creatinine values from 2 months prior to an episode of biopsy-proven rejection and up to 2 months after rejection resolution and cessation of high dose of immunosuppressive therapy. Allograft dysfunction related to allograft rejection data from Month 24 up to Month 49 will be provided at the final results disclosure stage.	From Month 24 (pre-revaccination) up to Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study
Number of Participants With Allograft Dysfunction Related to HZ Episodes in the Revaccination Active and Follow-up Phases of the Current ZOSTER-073 Study	Declining allograft function will be assessed through all clinically obtained serum creatinine values from 2 months prior to an episode of HZ and up to 2 months after HZ resolution. Allograft dysfunction related to HZ episodes data from Month 24 up to Month 49 will be provided at the final results disclosure stage.	From Month 24 (pre-revaccination) up to Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2019
• Primary Completion (Actual): August 12, 2022
• Study Completion (Estimated): August 14, 2024

Study Registration Dates

• First Submitted: November 22, 2019
• First Submitted That Met QC Criteria: November 22, 2019
• First Posted (Actual): November 25, 2019

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Herpesviridae Infections; Varicella Zoster Virus Infection; Herpes Zoster; Herpes Simplex
• Other Study ID Numbers: 212340; 2019-001815-21 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• IPD Sharing Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No