Safety and Immunogenicity of Recombinant Zoster Vaccine for Transplant Recipients

NCT06262776 | Recruiting

• 1 other identifier: SIRZOSTER1.01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare responses to Varicella Zoster vaccination between transplant patients on different medication regimens, and their healthy co-habitants. The main questions it aims to answer are:

1. 1.Are there differences in vaccination immunological responses in transplant patients on different immunosuppression regimens?
2. 2.Are there differences in vaccination immunological responses between transplant patients and their healthy co-habitants? Participants will all receive a 2-dose course of SHINGRIX recombinant Zoster vaccination, and have immunological responses measured and compared at 5 timepoints between 1 week to 1 year post-vaccination.

Conditions

Immunosuppression; Vaccine Response Impaired

Outcome Measures

Primary Outcomes (1)

• Functional T cell memory

  ELISpot measurement of interferon gamma spot-forming units following 18-hour stimulation of peripheral blood mononuclear cells with Zoster gE protein-derived peptide array

  3 weeks following second vaccine dose

Secondary Outcomes (6)

• Frequency of virus specific T cells

  3 weeks and 52 weeks following second vaccine dose

• Magnitude of antibody response

  3 weeks and 52 weeks following second vaccine dose

• Concentration of post-vaccination circulating cytokines

  3 weeks following second vaccine dose

• Frequency of polyfunctional T cells

  3 weeks and 52 weeks following second vaccine dose

• Magnitude of vaccine-induced cross-protective antiviral responses

  3 weeks and 52 weeks following second vaccine dose

Other Outcomes (3)

• Incidence of shingles

  12 months

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  12 months

• Tolerability of vaccination regimen as assessed by EQ-5D

  3 weeks following second vaccine dose

Study Arms (1)

Vaccination group

EXPERIMENTAL

All participants will receive the assigned intervention, a 2-dose course of Zoster recombinant adjuvanted vaccine. Study participants will include kidney transplant recipients receiving specific immunosuppressive medications, and non-immunosuppressed household cohabitants, with comparisons made in magnitude of vaccine response.

Biological: Recombinant zoster vaccine adjuvanted (SHINGRIX)

Interventions

Recombinant zoster vaccine adjuvanted (SHINGRIX) BIOLOGICAL

2 doses of 0.5mL recombinant zoster vaccine adjuvanted intramuscular injection at week 0 and week 8.

Vaccination group

Eligibility Criteria

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

You may qualify if:

• Household co-habitant of transplant recipient in trial
• Aged \>50 years
• Previous documented infection with VZV (known infection history or positive VZV IgG result)

You may not qualify if:

• Aged \<50 years
• Unable or unwilling to provide informed consent to participate in the trial
• Known allergy to or intolerance of the contents of the RZV vaccine
• No previous infection with VZV (chickenpox)
• History of primary immunodeficiency, documented vaccine hypo-responsiveness, or active immunosuppressive therapy
• Population - Groups 2-4. Transplant recipients (n = 90)
• Organ transplant recipients
• \-- Specific immunosuppression regimen
• Tacrolimus, mycophenolate, prednisolone (n = 30, Group 2)
• Tacrolimus, mTORi, prednisolone (n = 30, Group 3)
• mTORi, mycophenolate, prednisolone (n = 30, Group 4)
• Aged \>18 years
• estimated GFR \> 15 mL/min/1.73m2
• Previous documented infection with VZV (known infection history or positive VZV IgG result)
• Aged \<18 years

Sponsors & Collaborators

• University of Adelaide: collaborator
• Royal Prince Alfred Hospital, Sydney, Australia: collaborator
• Central Adelaide Local Health Network Incorporated: lead
• National Health and Medical Research Council, Australia: collaborator

Study Sites (1)

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

RECRUITING

Study Officials

• Patrick T Coates, FRACP

  Central and Northern Adelaide Renal and Transplantation Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick T Coates, MBBS, FRACP, PhD

CONTACT

70740000; Toby.Coates@sa.gov.au

Griffith B Perkins, PhD

CONTACT

70740000; Griffith.Perkins@adelaide.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 16, 2024
• Study Start: March 20, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be made available following publication of trial results, and will be available in perpetuity.
• Access Criteria: Trial results and supporting information outlined above will be made available through open access publishing.

Locations

AU (1)