Trial Outcomes & Findings for 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 (NCT NCT04176939)

NCT ID: NCT04176939

Last Updated: 2025-07-18

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 68 participants
• Primary outcome timeframe: At Day 1, Month 12 and Month 24 (pre-revaccination) in the current ZOSTER-073 study
• Results posted on: 2025-07-18

Participant Flow

Eligible participants from the Herpes Zoster (HZ/su) treatment group of ZOSTER-041 (NCT02058589) study who had a complete primary vaccination course (2 doses of HZ/su vaccine) were offered enrollment in the current ZOSTER-073 study (NCT04176939). A total of 68 participants met the eligibility criteria and consented to participate in this study.

Out of the 68 participants originally enrolled in the current ZOSTER-073 study (Enrolled Set), 21 participants did not receive any revaccination doses, hence only 47 participants were vaccinated with at least one revaccination dose and included in the Exposed Set for revaccination phase in this study.

Participant milestones

Measure	HZ/su Group Participants with renal transplant who completed the 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study were enrolled in the current ZOSTER-073 (NCT04176939) 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.
Overall Study STARTED	68
Overall Study Revaccinated	47
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Measure	HZ/su Group Participants with renal transplant who completed the 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study were enrolled in the current ZOSTER-073 (NCT04176939) 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.
Overall Study Withdrawal by Subject	5
Overall Study Migrated / Moved From The Study Area	1
Overall Study Lost to Follow-up	2
Overall Study Unspecified reason	4
Overall Study Adverse Event Requiring Expedited Reporting	7

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	HZ/su Group n=68 Participants Participants with renal transplant who completed the 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study were enrolled in the current ZOSTER-073 (NCT04176939) 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.
Age, Continuous	58.5 Years STANDARD_DEVIATION 12.3 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants
Race/Ethnicity, Customized ASIAN	14 Participants n=5 Participants
Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN	3 Participants n=5 Participants
Race/Ethnicity, Customized WHITE	46 Participants n=5 Participants
Race/Ethnicity, Customized OTHER - UNSPECIFIED	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Day 1, Month 12 and Month 24 (pre-revaccination) in the current ZOSTER-073 study

Population: Analysis was performed on the Per Protocol Set for analysis of persistence (LTFU phase), which included evaluable participants from the Enrolled Set with a complete vaccination course (2 doses of HZ/su vaccine) in the ZOSTER-041 study, who met the eligibility criteria and signed informed consent in the current study and for whom persistence immunogenicity results after primary vaccination course were available at the specified time points in the current study, regardless of revaccination status.

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).

Outcome measures

Measure	HZ/su Group n=60 Participants Participants with renal transplant who completed the 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study were enrolled in the current ZOSTER-073 (NCT04176939) 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.
Anti-glycoprotein E (Anti-gE) Antibody Concentrations, as Assessed in the Long Term Follow-up (LTFU) Phase of the Current ZOSTER-073 Study At Day 1	3729.8 mIU/mL Interval 2736.2 to 5084.0
Anti-glycoprotein E (Anti-gE) Antibody Concentrations, as Assessed in the Long Term Follow-up (LTFU) Phase of the Current ZOSTER-073 Study At Month 12	3440.2 mIU/mL Interval 2499.0 to 4735.7
Anti-glycoprotein E (Anti-gE) Antibody Concentrations, as Assessed in the Long Term Follow-up (LTFU) Phase of the Current ZOSTER-073 Study At Month 24	3075.8 mIU/mL Interval 2091.8 to 4522.8

PRIMARY outcome

Timeframe: At Month 24 (pre-revaccination), Month 25 (1 month post-revaccination Dose 1) and Month 26 (1 month post-revaccination Dose 2) in the current ZOSTER-073 study

Population: Analysis was performed on the Per Protocol Set for Immunogenicity after revaccination course (Revaccination active phase), which included evaluable participants who were administered 1 or 2 doses of revaccination as per the revaccination schedule and who had immunogenicity data available for the specified analysis at the specified time points in the current study.

Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in mIU/mL.

Outcome measures

Measure	HZ/su Group n=45 Participants Participants with renal transplant who completed the 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study were enrolled in the current ZOSTER-073 (NCT04176939) 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.
Anti-gE Antibody Concentrations, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study At Month 26	31517.0 mIU/mL Interval 21581.1 to 46027.3
Anti-gE Antibody Concentrations, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study At Month 24	2828.5 mIU/mL Interval 1886.6 to 4240.5
Anti-gE Antibody Concentrations, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study At Month 25	27655.5 mIU/mL Interval 17882.7 to 42769.1

SECONDARY outcome

Timeframe: At Day 1, Month 12 and Month 24 (pre-revaccination) in the current ZOSTER-073 study

Population: Analysis was performed on a sub-cohort of participants from the Per Protocol Set for analysis of persistence (LTFU phase), for whom an additional blood sample for cell-mediated immunity (CMI) analysis was collected and who had CMI results available for the specified analysis at the specified time points in the current study.

Frequency of gE-specific CD4 (2+) T-cells expressing two or more activation markers (from among interferon gamma [IFN-γ], interleukin-2 [IL-2], tumour necrosis factor alpha [TNF-α] and CD40 Ligand [CD40L]) was determined by intracellular cytokine staining (ICS) as measured by cytokine flow cytometry (CFC) and expressed in CD4(2+) T-cells per million cells [CD4(2+) T-cells/million cells].

Outcome measures

Measure	HZ/su Group n=28 Participants Participants with renal transplant who completed the 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study were enrolled in the current ZOSTER-073 (NCT04176939) 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.
Frequency of gE-specific Cluster of Differentiation 4 (CD4) (2+) T-cells, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study At Day 1	608.9 CD4(2+) T-cells/million cells Interval 167.2 to 993.6
Frequency of gE-specific Cluster of Differentiation 4 (CD4) (2+) T-cells, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study At Month 12	299.4 CD4(2+) T-cells/million cells Interval 105.3 to 1068.4
Frequency of gE-specific Cluster of Differentiation 4 (CD4) (2+) T-cells, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study At Month 24	711.0 CD4(2+) T-cells/million cells Interval 309.9 to 1211.0

SECONDARY outcome

Timeframe: From Month 13 (last visit) in ZOSTER-041 study until Month 24 in the current ZOSTER-073 study

Population: Analysis was performed on the Enrolled Set, which included all participants with a complete vaccination course (2 doses of HZ/su vaccine) in ZOSTER-041 study who met the eligibility criteria and signed informed consent in the current 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 participant. SAEs related to primary vaccination in ZOSTER-041 study were assessed by the investigator.

Outcome measures

Measure

HZ/su Group n=68 Participants Participants with renal transplant who completed the 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study were enrolled in the current ZOSTER-073 (NCT04176939) 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.

Number of Participants With Serious Adverse Events (SAEs) Related to Primary Vaccination in ZOSTER-041 Study, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study

0 Participants

SECONDARY outcome

Timeframe: From Month 13 (last visit) in ZOSTER-041 study until Day 1 (first visit) in the current ZOSTER-073 study

Population: Analysis was performed on the Enrolled Set, which included all participants with a complete vaccination course (2 doses of HZ/su vaccine) in ZOSTER-041 study who met the eligibility criteria and signed informed consent in the current study.

A suspected HZ case 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 case was diagnosed by an algorithm that included Polymerase Chain Reaction (PCR) and the HZ Ascertainment Committee (HZAC) determination.

Outcome measures

Measure	HZ/su Group n=68 Participants Participants with renal transplant who completed the 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study were enrolled in the current ZOSTER-073 (NCT04176939) 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.
Number of Participants With Suspected or Confirmed Herpes Zoster (HZ) Cases, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study Confirmed HZ case	0 Participants
Number of Participants With Suspected or Confirmed Herpes Zoster (HZ) Cases, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study Suspected HZ case	3 Participants

SECONDARY outcome

Timeframe: From Day 1 until Month 24 in the current ZOSTER-073 study

Population: Analysis was performed on the Enrolled Set, which included all participants with a complete vaccination course (2 doses of HZ/su vaccine) in ZOSTER-041 primary study who met the eligibility criteria and signed informed consent in the current study.

A confirmed HZ case was diagnosed by an algorithm that included Polymerase Chain Reaction (PCR) and the HZ Ascertainment Committee (HZAC) determination.

Outcome measures

Measure

HZ/su Group n=68 Participants Participants with renal transplant who completed the 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study were enrolled in the current ZOSTER-073 (NCT04176939) 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.

Number of Participants With Confirmed HZ Cases, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study

3 Participants

SECONDARY outcome

Timeframe: From Month 13 (last visit) in ZOSTER-041 study until Day 1 (first visit) in the current ZOSTER-073 study

Population: Analysis was performed on the Enrolled Set, which included all participants with a complete vaccination course (2 doses of HZ/su vaccine) in ZOSTER-041 study who met the eligibility criteria and signed informed consent in the current study.

The number of participants with biopsy for clinical indication (suspected) or surveillance protocol that was not biopsy-proven rejection and with biopsy-proven allograft rejections are reported. Biopsy-proven allograft rejections are defined as adverse events of specific interest (AESIs).

Outcome measures

Measure	HZ/su Group n=68 Participants Participants with renal transplant who completed the 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study were enrolled in the current ZOSTER-073 (NCT04176939) 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.
Number of Participants With Suspected or Biopsy-proven Allograft Rejections, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study Biopsy-proven allograft rejection	0 Participants
Number of Participants With Suspected or Biopsy-proven Allograft Rejections, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study Biopsy for clinical indication (suspected) or surveillance protocol	5 Participants

SECONDARY outcome

Timeframe: From Day 1 until Month 24 in the current ZOSTER-073 study

Population: Analysis was performed on the Enrolled Set, which included all participants with a complete vaccination course (2 doses of HZ/su vaccine) in ZOSTER-041 study who met the eligibility criteria and signed informed consent in the current study.

Biopsy-proven allograft rejection is defined as an adverse event of specific interest (AESI).

Outcome measures

Measure

HZ/su Group n=68 Participants Participants with renal transplant who completed the 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study were enrolled in the current ZOSTER-073 (NCT04176939) 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.

Number of Participants With Biopsy-proven Allograft Rejections, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study

2 Participants

SECONDARY outcome

Timeframe: From Month 13 (last visit) in ZOSTER-041 study until Month 24 in the current ZOSTER-073 study

Population: Analysis was performed on the Enrolled Set, which included all participants with a complete vaccination course (2 doses of HZ/su vaccine) in ZOSTER-041 primary study who met the eligibility criteria and signed informed consent in the current 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 therapeutic immunosuppressive therapy. Allograft dysfunction is defined as having a fold increase in serum creatinine of 1.2 greater from the reference timepoint (2 months prior to an episode of biopsy-proven rejection).

Outcome measures

Measure

HZ/su Group n=68 Participants Participants with renal transplant who completed the 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study were enrolled in the current ZOSTER-073 (NCT04176939) 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.

Number of Participants With Allograft Dysfunction Related to Allograft Rejection Episodes, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study

0 Participants

SECONDARY outcome

Timeframe: From Month 13 (last visit) in ZOSTER-041 study until Month 24 in the current ZOSTER-073 study

Population: Analysis was performed on the Enrolled Set, which included all participants with a complete vaccination course (2 doses of HZ/su vaccine) in ZOSTER-041 study who met the eligibility criteria and signed informed consent in the current 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. Allograft dysfunction is defined as having a fold increase in serum creatinine of 1.2 greater from the reference timepoint (2 months prior to an episode of HZ).

Outcome measures

Measure

HZ/su Group n=68 Participants Participants with renal transplant who completed the 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study were enrolled in the current ZOSTER-073 (NCT04176939) 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.

Number of Participants With Allograft Dysfunction Related to HZ Episodes, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study

0 Participants

SECONDARY outcome

Timeframe: At Month 24 (pre-revaccination), Month 25 (1 month post-revaccination Dose 1) and Month 26 (1 month post-revaccination Dose 2) in the current ZOSTER-073 study

Population: Analysis was performed on a sub-cohort of participants from the Per Protocol Set for Immunogenicity after revaccination course (Revaccination active phase), for whom an additional blood sample for CMI analysis was collected and who had CMI results available for the specified analysis at the specified time points in the current study.

Frequency of gE-specific CD4 (2+) T-cells expressing two or more activation markers (from among IFN-γ, IL-2, TNF-α and CD40L) was determined by ICS as measured by CFC and expressed in CD4(2+) T-cells/million cells.

Outcome measures

Measure	HZ/su Group n=23 Participants Participants with renal transplant who completed the 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study were enrolled in the current ZOSTER-073 (NCT04176939) 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.
Frequency of gE-specific CD4(2+) T-cells, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study At Month 25	4476.2 CD4(2+) T-cells/million cells Interval 3136.7 to 7704.6
Frequency of gE-specific CD4(2+) T-cells, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study At Month 24	793.5 CD4(2+) T-cells/million cells Interval 309.9 to 1235.8
Frequency of gE-specific CD4(2+) T-cells, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study At Month 26	3747.3 CD4(2+) T-cells/million cells Interval 2758.1 to 8906.2

SECONDARY outcome

Timeframe: At Month 37 (12 months post-revaccination Dose 2) and Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study

Population: Analysis was performed on the Per Protocol Set for persistence after revaccination course (Revaccination follow-up phase), which included evaluable participants who received 2 doses of revaccination in the current ZOSTER-073 study and for whom immunogenicity persistence results after revaccination were available for the specified analysis at the specified time points in the current study.

Persistence of humoral immunity after the revaccination course was evaluated in terms of anti-gE antibody concentrations. Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in mIU/mL.

Outcome measures

Measure	HZ/su Group n=44 Participants Participants with renal transplant who completed the 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study were enrolled in the current ZOSTER-073 (NCT04176939) 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.
Anti-gE Antibody Concentrations, as Assessed in the Revaccination Follow-up Phase of the Current ZOSTER-073 Study At Month 37	23989.4 mIU/mL Interval 17539.6 to 32811.0
Anti-gE Antibody Concentrations, as Assessed in the Revaccination Follow-up Phase of the Current ZOSTER-073 Study At Month 49	9985.8 mIU/mL Interval 5917.8 to 16850.0

SECONDARY outcome

Timeframe: At Month 37 (12 months post-revaccination Dose 2) and Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study

Population: Analysis was performed on a sub-cohort of participants from the Per Protocol Set for persistence after revaccination course (Revaccination follow-up phase), for whom an additional blood sample for CMI analysis was collected and who had CMI results available for the specified analysis at the specified time points in the current study.

Frequency of gE-specific CD4 (2+) T-cells expressing two or more activation markers (from among IFN-γ, IL-2, TNF-α and CD40L) was determined by ICS as measured by CFC and expressed in CD4(2+) T-cells/million cells.

Outcome measures

Measure	HZ/su Group n=20 Participants Participants with renal transplant who completed the 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study were enrolled in the current ZOSTER-073 (NCT04176939) 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.
Frequency of gE-specific CD4(2+) T-cells, as Assessed in the Revaccination Follow-up Phase of the Current ZOSTER-073 Study At Month 37	1777.4 CD4(2+) T-cells/million cells Interval 1297.7 to 2505.4
Frequency of gE-specific CD4(2+) T-cells, as Assessed in the Revaccination Follow-up Phase of the Current ZOSTER-073 Study At Month 49	1144.9 CD4(2+) T-cells/million cells Interval 818.1 to 2724.1

SECONDARY outcome

Timeframe: Within 7 days after each revaccination dose (administered at Month 24 [Dose 1] and at Month 25 [Dose 2]) in the current ZOSTER-073 study

Population: Analysis was performed on the Exposed Set for revaccination phase, which included all participants with at least one HZ/su revaccination dose administered in the current study and with the solicited administration site events diary card data available after the corresponding revaccination, for the specified duration.

Assessed solicited administration site events included erythema, pain and swelling at injection site. Any = occurrence of the event regardless of intensity grade. Any erythema/swelling at injection site = erythema/swelling at injection site with a diameter larger than (>) 20 millimeters (mm). Grade 3 pain = significant pain at rest, which prevented normal, everyday activities. Grade 3 erythema/swelling at injection site = erythema/swelling at injection site with a diameter >100 mm.

Outcome measures

Measure	HZ/su Group n=45 Participants Participants with renal transplant who completed the 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study were enrolled in the current ZOSTER-073 (NCT04176939) 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.
Number of Participants With Any and Grade 3 Solicited Administration Site Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Grade 3 Erythema, after revaccination Dose 2	0 Participants
Number of Participants With Any and Grade 3 Solicited Administration Site Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Any Pain, after revaccination Dose 1	37 Participants
Number of Participants With Any and Grade 3 Solicited Administration Site Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Grade 3 Pain, after revaccination Dose 1	7 Participants
Number of Participants With Any and Grade 3 Solicited Administration Site Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Any Swelling, after revaccination Dose 2	4 Participants
Number of Participants With Any and Grade 3 Solicited Administration Site Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Any Erythema, after revaccination Dose 1	9 Participants
Number of Participants With Any and Grade 3 Solicited Administration Site Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Grade 3 Erythema, after revaccination Dose 1	0 Participants
Number of Participants With Any and Grade 3 Solicited Administration Site Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Any Erythema, after revaccination Dose 2	6 Participants
Number of Participants With Any and Grade 3 Solicited Administration Site Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Any Pain, after revaccination Dose 2	31 Participants
Number of Participants With Any and Grade 3 Solicited Administration Site Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Grade 3 Pain, after revaccination Dose 2	2 Participants
Number of Participants With Any and Grade 3 Solicited Administration Site Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Any Swelling, after revaccination Dose 1	7 Participants
Number of Participants With Any and Grade 3 Solicited Administration Site Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Grade 3 Swelling, after revaccination Dose 1	0 Participants
Number of Participants With Any and Grade 3 Solicited Administration Site Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Grade 3 Swelling, after revaccination Dose 2	0 Participants

SECONDARY outcome

Timeframe: Within 7 days after each revaccination dose (administered at Month 24 [Dose 1] and at Month 25 [Dose 2]) in the current ZOSTER-073 study

Population: Analysis was performed on the Exposed Set for revaccination phase, which included participants with at least one HZ/su revaccination dose administered in the current study, with solicited diary data available after the corresponding revaccination, who experienced the specified solicited administration site event within 7 days following the respective revaccination dose and with the duration documented.

Duration is the number of days in which a participant experienced the solicited administration site event within the 7-day solicited follow-up period. Assessed solicited administration site events included erythema, pain and swelling at injection site.

Outcome measures

Measure	HZ/su Group n=37 Participants Participants with renal transplant who completed the 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study were enrolled in the current ZOSTER-073 (NCT04176939) 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.
Duration in Days of Solicited Administration Site Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Swelling, after revaccination Dose 2	2.5 Days Interval 1.5 to 3.5
Duration in Days of Solicited Administration Site Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Erythema, after revaccination Dose 1	4.0 Days Interval 1.0 to 5.0
Duration in Days of Solicited Administration Site Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Pain, after revaccination Dose 1	3.0 Days Interval 2.0 to 4.0
Duration in Days of Solicited Administration Site Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Swelling, after revaccination Dose 1	3.0 Days Interval 2.0 to 3.0
Duration in Days of Solicited Administration Site Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Erythema, after revaccination Dose 2	3.0 Days Interval 2.0 to 3.0
Duration in Days of Solicited Administration Site Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Pain, after revaccination Dose 2	2.0 Days Interval 2.0 to 3.0

SECONDARY outcome

Timeframe: Within 7 days after each revaccination dose (administered at Month 24 [Dose 1] and at Month 25 [Dose 2]) in the current ZOSTER-073 study

Population: Analysis was performed on the Exposed Set for revaccination phase, which included all participants with at least one HZ/su revaccination dose administered in the current study and with the solicited systemic events diary card data available after the corresponding revaccination, for the specified duration.

Assessed solicited systemic events included fatigue, gastrointestinal symptoms (including nausea, vomiting, diarrhea and/or abdominal pain), headache, myalgia, shivering and fever [temperature higher than or equal (>=) to 38.0 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F)]. Any AE = occurrence of the event regardless of intensity grade. Grade 3 fatigue, gastrointestinal symptoms, headache, myalgia, shivering = event that prevented normal, everyday activities. Grade 3 fever = temperature higher (>) than 39°C/102.2°F. Related fatigue, gastrointestinal symptoms, headache, myalgia, shivering, fever = event assessed by the investigator as related to the revaccination. The preferred route for measuring temperature in this study was oral.

Outcome measures

Measure	HZ/su Group n=46 Participants Participants with renal transplant who completed the 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study were enrolled in the current ZOSTER-073 (NCT04176939) 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.
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Related Gastrointestinal symptoms, after revaccination Dose 1	10 Participants
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Any Gastrointestinal symptoms, after revaccination Dose 2	10 Participants
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Grade 3 Gastrointestinal symptoms, after revaccination Dose 2	1 Participants
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Related Gastrointestinal symptoms, after revaccination Dose 2	9 Participants
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Related Fatigue, after revaccination Dose 1	22 Participants
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Any Gastrointestinal symptoms, after revaccination Dose 1	11 Participants
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Any Headache, after revaccination Dose 2	16 Participants
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Grade 3 Myalgia, after revaccination Dose 2	1 Participants
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Related Myalgia, after revaccination Dose 2	16 Participants
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Any Shivering, after revaccination Dose 1	15 Participants
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Grade 3 Shivering, after revaccination Dose 1	3 Participants
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Any Fever, after revaccination Dose 1	4 Participants
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Grade 3 Fever, after revaccination Dose 1	1 Participants
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Related Fever, after revaccination Dose 1	4 Participants
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Any Fever, after revaccination Dose 2	4 Participants
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Any Fatigue, after revaccination Dose 1	26 Participants
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Grade 3 Fatigue, after revaccination Dose 1	2 Participants
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Any Fatigue, after revaccination Dose 2	23 Participants
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Grade 3 Fatigue, after revaccination Dose 2	2 Participants
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Related Fatigue, after revaccination Dose 2	21 Participants
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Grade 3 Gastrointestinal symptoms, after revaccination Dose 1	0 Participants
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Any Headache, after revaccination Dose 1	22 Participants
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Grade 3 Headache, after revaccination Dose 1	3 Participants
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Related Headache, after revaccination Dose 1	19 Participants
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Grade 3 Headache, after revaccination Dose 2	0 Participants
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Related Headache, after revaccination Dose 2	16 Participants
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Any Myalgia, after revaccination Dose 1	21 Participants
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Grade 3 Myalgia, after revaccination Dose 1	1 Participants
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Related Myalgia, after revaccination Dose 1	17 Participants
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Any Myalgia, after revaccination Dose 2	19 Participants
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Related Shivering, after revaccination Dose 1	13 Participants
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Any Shivering, after revaccination Dose 2	10 Participants
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Grade 3 Shivering, after revaccination Dose 2	1 Participants
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Related Shivering, after revaccination Dose 2	9 Participants
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Grade 3 Fever, after revaccination Dose 2	1 Participants
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Related Fever, after revaccination Dose 2	4 Participants

SECONDARY outcome

Timeframe: Within 7 days after each revaccination dose (administered at Month 24 [Dose 1] and at Month 25 [Dose 2]) in the current ZOSTER-073 study

Population: Analysis was performed on the Exposed Set for revaccination phase, which included participants with at least one HZ/su revaccination dose administered in the current study, with solicited diary data available after the corresponding revaccination, who experienced the specified solicited systemic event within 7 days following the respective revaccination dose and with the duration documented.

Duration is the number of days in which a participant experienced the solicited systemic event within the 7-day solicited follow-up period. Assessed solicited systemic events included fatigue, gastrointestinal symptoms (including nausea, vomiting, diarrhea and/or abdominal pain), headache, myalgia, shivering and fever.

Outcome measures

Measure	HZ/su Group n=26 Participants Participants with renal transplant who completed the 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study were enrolled in the current ZOSTER-073 (NCT04176939) 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.
Duration in Days of Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Fatigue, after revaccination Dose 1	3.0 Days Interval 2.0 to 3.0
Duration in Days of Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Gastrointestinal symptoms, after revaccination Dose 1	2.0 Days Interval 1.0 to 2.0
Duration in Days of Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Headache, after revaccination Dose 1	2.0 Days Interval 1.0 to 3.0
Duration in Days of Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Myalgia, after revaccination Dose 1	2.0 Days Interval 2.0 to 4.0
Duration in Days of Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Shivering, after revaccination Dose 1	1.0 Days Interval 1.0 to 2.0
Duration in Days of Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Fever, after revaccination Dose 1	1.5 Days Interval 1.0 to 2.0
Duration in Days of Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Fatigue, after revaccination Dose 2	2.0 Days Interval 2.0 to 4.0
Duration in Days of Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Gastrointestinal symptoms, after revaccination Dose 2	1.5 Days Interval 1.0 to 2.0
Duration in Days of Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Headache, after revaccination Dose 2	2.0 Days Interval 1.0 to 3.0
Duration in Days of Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Myalgia, after revaccination Dose 2	2.0 Days Interval 1.0 to 4.0
Duration in Days of Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Shivering, after revaccination Dose 2	2.0 Days Interval 1.0 to 2.0
Duration in Days of Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Fever, after revaccination Dose 2	1.0 Days Interval 1.0 to 1.0

SECONDARY outcome

Timeframe: Within 30 days (across revaccination doses) post-revaccination period in the current ZOSTER-073 study

Population: Analysis was performed on the Exposed Set for revaccination phase, which included all participants with at least one HZ/su revaccination dose administered in the current study and for whom unsolicited AEs data were available for the specified duration.

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 = occurrence of the event regardless of intensity grade or relation to revaccination. Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as related to revaccination.

Outcome measures

Measure	HZ/su Group n=47 Participants Participants with renal transplant who completed the 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study were enrolled in the current ZOSTER-073 (NCT04176939) 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.
Number of Participants With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Post-revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Any unsolicited AE(s)	12 Participants
Number of Participants With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Post-revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Grade 3 unsolicited AE(s)	3 Participants
Number of Participants With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Post-revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Related unsolicited AE(s)	2 Participants

SECONDARY outcome

Timeframe: From Month 24 (pre-revaccination) until Month 37 (12 months post-revaccination Dose 2) in the current ZOSTER-073 study

Population: Analysis was performed on the Exposed Set for revaccination phase, which included all participants with at least one HZ/su revaccination dose administered in the current study and for whom SAEs data were available for the specified duration.

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 participant. Any = occurrence of the SAE regardless of intensity grade or relation to revaccination. Fatal = SAE resulting in the death of the participant.

Outcome measures

Measure	HZ/su Group n=47 Participants Participants with renal transplant who completed the 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study were enrolled in the current ZOSTER-073 (NCT04176939) 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.
Number of Participants With Any Serious Adverse Events (SAEs) and Fatal SAEs, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Any SAE(s)	9 Participants
Number of Participants With Any Serious Adverse Events (SAEs) and Fatal SAEs, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Fatal SAE(s)	1 Participants

SECONDARY outcome

Timeframe: From Month 24 (pre-revaccination) until Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study

Population: Analysis was performed on the Exposed Set for revaccination phase, which included all participants with at least one HZ/su revaccination dose administered in the current study and for whom SAEs data were available for the specified duration.

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 participant. Related = SAE assessed by the investigator as related to revaccination. Related-fatal = SAE resulting in the death of the participant assessed by the investigator as related to revaccination.

Outcome measures

Measure	HZ/su Group n=47 Participants Participants with renal transplant who completed the 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study were enrolled in the current ZOSTER-073 (NCT04176939) 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.
Number of Participants With Related SAEs and Related-fatal SAEs, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Related SAE(s)	0 Participants
Number of Participants With Related SAEs and Related-fatal SAEs, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study Related-fatal SAE(s)	0 Participants

SECONDARY outcome

Timeframe: From Month 24 (pre-revaccination) until Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study

Population: Analysis was performed on the Exposed Set for revaccination phase, which included all participants with at least one HZ/su revaccination dose administered in the current study and for whom biopsy-proven allograft rejections data were available for the specified duration.

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 by the investigator as related to revaccination.

Outcome measures

Measure	HZ/su Group n=47 Participants Participants with renal transplant who completed the 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study were enrolled in the current ZOSTER-073 (NCT04176939) 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.
Number of Participants With Any and Related Biopsy-proven Allograft Rejections, as Assessed in the Revaccination Active and Follow-up Phases of the Current ZOSTER-073 Study Any biopsy-proven allograft rejection	1 Participants
Number of Participants With Any and Related Biopsy-proven Allograft Rejections, as Assessed in the Revaccination Active and Follow-up Phases of the Current ZOSTER-073 Study Related biopsy-proven allograft rejection	0 Participants

SECONDARY outcome

Timeframe: From Month 24 (pre-revaccination) until Month 37 (12 months post-revaccination Dose 2) in the current ZOSTER-073 study

Population: Analysis was performed on the Exposed Set for revaccination phase, which included all participants with at least one HZ/su revaccination dose administered in the current study and for whom pIMDs data were available for the specified duration.

pIMDs are defined as 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. Any = occurrence of the pIMD regardless of intensity grade or relation to revaccination. Related = pIMDs assessed by the investigator as related to revaccination.

Outcome measures

Measure	HZ/su Group n=47 Participants Participants with renal transplant who completed the 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study were enrolled in the current ZOSTER-073 (NCT04176939) 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.
Number of Participants With Any and Related Potential Immune-mediated Diseases (pIMDs), as Assessed in the Revaccination Active and Follow-up Phases of the Current ZOSTER-073 Study Related pIMD(s)	0 Participants
Number of Participants With Any and Related Potential Immune-mediated Diseases (pIMDs), as Assessed in the Revaccination Active and Follow-up Phases of the Current ZOSTER-073 Study Any pIMD(s)	1 Participants

SECONDARY outcome

Timeframe: From Month 24 (pre-revaccination) until Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study

Population: Analysis was performed on the Exposed Set for revaccination phase, which included all participants with at least one HZ/su revaccination dose administered in the current study and for whom HZ cases data were available for the specified duration.

A confirmed HZ case was diagnosed by an algorithm that included Polymerase Chain Reaction (PCR) and the HZ Ascertainment Committee (HZAC) determination.

Outcome measures

Measure

HZ/su Group n=47 Participants Participants with renal transplant who completed the 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study were enrolled in the current ZOSTER-073 (NCT04176939) 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.

Number of Participants With Confirmed HZ Cases, as Assessed in the Revaccination Active and Follow-up Phases of the Current ZOSTER-073 Study

0 Participants

SECONDARY outcome

Timeframe: From Month 24 (pre-revaccination) until Month 37 (12 months post-revaccination Dose 2) in the current ZOSTER-073 study

Population: Analysis was performed on the Exposed Set for revaccination phase, which included all participants with at least one HZ/su revaccination dose administered in the current study and for whom allograft dysfunction following revaccination data were available for the specified duration.

Declining allograft function was 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 is defined as having a fold increase in serum creatinine of 1.2 greater from the reference timepoint (3 months prior to revaccination).

Outcome measures

Measure

HZ/su Group n=33 Participants Participants with renal transplant who completed the 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study were enrolled in the current ZOSTER-073 (NCT04176939) 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.

Number of Participants With Allograft Dysfunction Following Revaccination, as Assessed in the Revaccination Active and Follow-up Phases of the Current ZOSTER-073 Study

4 Participants

SECONDARY outcome

Timeframe: From Month 24 (pre-revaccination) until Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study

Population: Analysis was performed on the Exposed Set for revaccination phase, which included all participants with at least one HZ/su revaccination dose administered in the current study and for whom allograft dysfunction related to allograft rejection data were available for the specified duration.

Declining allograft function 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 therapeutic immunosuppressive therapy. Allograft dysfunction is defined as having a fold increase in serum creatinine of 1.2 greater from the reference timepoint (2 months prior to an episode of biopsy-proven rejection).

Outcome measures

Measure

HZ/su Group n=47 Participants Participants with renal transplant who completed the 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study were enrolled in the current ZOSTER-073 (NCT04176939) 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.

Number of Participants With Allograft Dysfunction Related to Allograft Rejection, as Assessed in the Revaccination Active and Follow-up Phases of the Current ZOSTER-073 Study

0 Participants

SECONDARY outcome

Timeframe: From Month 24 (pre-revaccination) until Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study

Population: Analysis was performed on the Exposed Set for revaccination phase, which included all participants with at least one HZ/su revaccination dose administered in the current study and for whom allograft dysfunction related to HZ episodes data were available for the specified duration.

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 resolution. Allograft dysfunction is defined as having a fold increase in serum creatinine of 1.2 greater from the reference timepoint (2 months prior to an episode of HZ).

Outcome measures

Measure

HZ/su Group n=47 Participants Participants with renal transplant who completed the 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study were enrolled in the current ZOSTER-073 (NCT04176939) 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.

Number of Participants With Allograft Dysfunction Related to HZ Episodes, as Assessed in the Revaccination Active and Follow-up Phases of the Current ZOSTER-073 Study

0 Participants

Adverse Events

HZ/su Group

Serious events: 23 serious events

Other events: 43 other events

Deaths: 7 deaths

Serious adverse events

Measure	HZ/su Group n=47 participants at risk；n=68 participants at risk Participants with renal transplant who completed the 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study were enrolled in the current ZOSTER-073 (NCT04176939) 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.
Infections and infestations COVID-19	8.8% 6/68 • Number of events 8 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Infections and infestations Klebsiella urinary tract infection	1.5% 1/68 • Number of events 1 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Nervous system disorders Cerebral haemorrhage	1.5% 1/68 • Number of events 1 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Nervous system disorders Intracranial pressure increased	1.5% 1/68 • Number of events 1 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Nervous system disorders Syncope	1.5% 1/68 • Number of events 1 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Liposarcoma	1.5% 1/68 • Number of events 1 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Immune system disorders Kidney transplant rejection	4.4% 3/68 • Number of events 3 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Injury, poisoning and procedural complications Meniscus injury	1.5% 1/68 • Number of events 1 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Psychiatric disorders Disorientation	1.5% 1/68 • Number of events 1 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Renal and urinary disorders Acute kidney injury	2.9% 2/68 • Number of events 2 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Respiratory, thoracic and mediastinal disorders Respiratory distress	1.5% 1/68 • Number of events 1 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Blood and lymphatic system disorders Anaemia	2.9% 2/68 • Number of events 2 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Cardiac disorders Cardiac failure	1.5% 1/68 • Number of events 2 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Cardiac disorders Acute myocardial infarction	1.5% 1/68 • Number of events 1 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Gastrointestinal disorders Diarrhoea	1.5% 1/68 • Number of events 1 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Infections and infestations COVID-19 Pneumonia	2.9% 2/68 • Number of events 2 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Infections and infestations Cytomegalovirus infection	1.5% 1/68 • Number of events 1 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Infections and infestations Herpes zoster	1.5% 1/68 • Number of events 1 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Infections and infestations Lower respiratory tract infection	1.5% 1/68 • Number of events 1 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Infections and infestations Pneumonia	2.9% 2/68 • Number of events 2 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Infections and infestations Pyelonephritis	1.5% 1/68 • Number of events 1 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Infections and infestations Pyelonephritis acute	1.5% 1/68 • Number of events 2 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Infections and infestations Staphylococcal bacteraemia	1.5% 1/68 • Number of events 1 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Injury, poisoning and procedural complications Subdural haemorrhage	1.5% 1/68 • Number of events 1 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Metabolism and nutrition disorders Cachexia	1.5% 1/68 • Number of events 1 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	1.5% 1/68 • Number of events 1 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified recurrent	1.5% 1/68 • Number of events 1 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	1.5% 1/68 • Number of events 1 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin squamous cell carcinoma metastatic	1.5% 1/68 • Number of events 1 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Renal and urinary disorders Renal impairment	1.5% 1/68 • Number of events 1 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	1.5% 1/68 • Number of events 1 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.5% 1/68 • Number of events 1 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.

Other adverse events

Measure	HZ/su Group n=47 participants at risk；n=68 participants at risk Participants with renal transplant who completed the 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study were enrolled in the current ZOSTER-073 (NCT04176939) 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.
General disorders Administration site pain	85.1% 40/47 • Number of events 68 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
General disorders Fatigue	66.0% 31/47 • Number of events 50 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
General disorders Chills	40.4% 19/47 • Number of events 25 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
General disorders Administration site swelling	34.0% 16/47 • Number of events 25 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
General disorders Administration site erythema	29.8% 14/47 • Number of events 22 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
General disorders Pyrexia	12.8% 6/47 • Number of events 9 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
General disorders Injection site pruritus	2.1% 1/47 • Number of events 1 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
General disorders Peripheral swelling	2.1% 1/47 • Number of events 1 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Musculoskeletal and connective tissue disorders Myalgia	55.3% 26/47 • Number of events 41 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Nervous system disorders Headache	57.4% 27/47 • Number of events 39 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Gastrointestinal disorders Gastrointestinal disorder	34.0% 16/47 • Number of events 21 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Gastrointestinal disorders Constipation	2.1% 1/47 • Number of events 1 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Infections and infestations COVID-19	6.4% 3/47 • Number of events 3 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Infections and infestations Onychomycosis	2.1% 1/47 • Number of events 1 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Eye disorders Blindness	2.1% 1/47 • Number of events 1 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Eye disorders Visual impairment	2.1% 1/47 • Number of events 1 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Metabolism and nutrition disorders Gout	2.1% 1/47 • Number of events 1 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	2.1% 1/47 • Number of events 1 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.
Skin and subcutaneous tissue disorders Eczema	2.1% 1/47 • Number of events 1 • Solicited AEs: Within 7 days after any revaccination; Unsolicited AEs: Within 30 days after any revaccination; SAEs and pIMDs: from Month 24 until Month 37; All-cause mortality, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study. As pre-specified in Protocol, events presented in the All-cause mortality and Serious Adverse Events modules were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set during the specified time frames. In the current ZOSTER-073 study, only revaccinated participants from the Exposed Set had their events in the Other Adverse Events module assessed during the specified time frames, and non-serious adverse events were not assessed in non-revaccinated participants.

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