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

NCT04176939 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 2123402019-001815-21
• Study Type: interventional
• Target: 68
• Locations: 7 countries
• Sites: 15

Brief Summary

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

Conditions

Herpes Zoster

Outcome Measures

Primary Outcomes (2)

• Anti-glycoprotein E (Anti-gE) Antibody Concentrations, as Assessed in the Long Term Follow-up (LTFU) Phase of the Current ZOSTER-073 Study

  Anti-gE antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in milli-international units per milliliter (mIU/mL).

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

• Anti-gE Antibody Concentrations, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study

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

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

Secondary Outcomes (24)

• 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, Month 12 and Month 24 (pre-revaccination) in the current ZOSTER-073 study

• 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

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

• Number of Participants With Suspected or Confirmed Herpes Zoster (HZ) Cases, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study

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

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

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

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

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

Study Arms (1)

HZ/su Group

EXPERIMENTAL

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.

Biological: HZ/su vaccine (GSK1437173A)

Interventions

HZ/su vaccine (GSK1437173A) BIOLOGICAL

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

HZ/su Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol or/and subjects' Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
• Written informed consent obtained from the subject/LAR(s) of the subject prior to performance of any study-specific procedure.
• Subjects who previously participated in study ZOSTER-041 and completed the full 2 dose HZ/su primary vaccination course.
• Subjects receiving maintenance CIS therapy for the prevention of allograft rejection for a minimum of one month prior to the first revaccination.
• Subjects without an episode of allograft rejection within 90 days prior to the first revaccination visit.
• Female subjects of non-childbearing potential may be revaccinated. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.
• Female subjects of childbearing potential may be revaccinated, if the subject:
• has practiced adequate contraception for 30 days prior to revaccination, and
• has a negative pregnancy test on the day of revaccination, and
• has agreed to continue adequate contraception up to 2 months after completion of the revaccination series.

You may not qualify if:

• Vaccination against HZ since completion of study ZOSTER-041.
• Significant underlying illness that, in the opinion of the investigator, is expected to prevent completion of the study.
• Any other condition that, in the opinion of the investigator, would interfere with the evaluations required by the study.
• Prior/Concurrent clinical study experience
• Concurrently participating in another interventional vaccine or immunosuppressive clinical study, in which the subject is exposed to an investigational or a non-investigational vaccine/product (drug) at any time during the ZOSTER-073 study.
• History of confirmed HZ within one year before revaccination visit (Visit 3).
• More than one organ transplanted.
• Any additional confirmed or suspected immunosuppressive or immunodeficient condition.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
• Any other condition that, in the opinion of the investigator, would interfere with the evaluations required by the study or make vaccination unsafe.
• Prior/Concomitant therapy
• Administration or planned administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the first revaccination dose of study vaccine and ending at Visit 5 (Month 26).
• Use of anti-CD20 or other B-cell monoclonal antibody agents as maintenance and/or therapeutic immunosuppressive therapy for the prevention of allograft rejection within 9 months of first revaccination dose of study vaccine.
• Evidence or high suspicion, in the opinion of the investigator, of noncompliance or nonadherence to use of maintenance immunosuppressive therapies.
• Planned administration/administration of a live vaccine in the period starting 30 days before the first dose and ending 30 days after the last dose of study vaccine administration.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (15)

GSK Investigational Site

Brussels, 1090, Belgium

Location

GSK Investigational Site

Toronto, Ontario, M5B 1W8, Canada

Location

GSK Investigational Site

Toronto, Ontario, M5G 2N2, Canada

Location

GSK Investigational Site

Helsinki, 00029, Finland

Location

GSK Investigational Site

Panama City, 1001, Panama

Location

GSK Investigational Site

Seoul, 06351, South Korea

Location

GSK Investigational Site

Seoul, 137-701, South Korea

Location

GSK Investigational Site

Barcelona, 08035, Spain

Location

GSK Investigational Site

Barcelona, 08036, Spain

Location

GSK Investigational Site

Barcelona, 08907, Spain

Location

GSK Investigational Site

Madrid, 28034, Spain

Location

GSK Investigational Site

Madrid, 28040, Spain

Location

GSK Investigational Site

Santander, 39008, Spain

Location

GSK Investigational Site

Seville, 41013, Spain

Location

GSK Investigational Site

Tau-Yuan, 333, Taiwan

Location

MeSH Terms

Conditions

Herpes Zoster

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: November 25, 2019
• Study Start: December 9, 2019
• Primary Completion: August 12, 2022
• Study Completion: June 27, 2024
• Last Updated: July 18, 2025
• Results First Posted: December 20, 2023

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

BE (1); ES (7); TW (1); FI (1); PA (1); CA (2); KR (2)