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Recruiting NCT06262776

Safety and Immunogenicity of Recombinant Zoster Vaccine for Transplant Recipients

No phase Interventional Immunosuppression Vaccine Response Impaired

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Recombinant zoster vaccine adjuvanted (SHINGRIX).
Who it may be relevant to
Registry conditions: Immunosuppression, Vaccine Response Impaired. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Safety and Immunogenicity of Recombinant Zoster Vaccine for Transplant Recipients (SIR ZOSTER)

Overview

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. Are there differences in vaccination immunological responses in transplant patients on different immunosuppression regimens? 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.

Interventions

  • Biological Recombinant zoster vaccine adjuvanted (SHINGRIX)
    2 doses of 0.5mL recombinant zoster vaccine adjuvanted intramuscular injection at week 0 and week 8.

Primary outcome measures

  • Functional T cell memory [Time frame: 3 weeks following second vaccine dose]
Secondary outcome measures (6)
  • Frequency of virus specific T cells [Time frame: 3 weeks and 52 weeks following second vaccine dose]
  • Magnitude of antibody response [Time frame: 3 weeks and 52 weeks following second vaccine dose]
  • Concentration of post-vaccination circulating cytokines [Time frame: 3 weeks following second vaccine dose]
  • Frequency of polyfunctional T cells [Time frame: 3 weeks and 52 weeks following second vaccine dose]
  • Magnitude of vaccine-induced cross-protective antiviral responses [Time frame: 3 weeks and 52 weeks following second vaccine dose]
  • Frequency of virus-specific T stem cell memory compared to baseline [Time frame: 3 weeks and 52 weeks following second vaccine dose]

Eligibility criteria

  • Population - Group 1. Healthy co-habitants (n = 30)

Inclusion criteria

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

Exclusion criteria

  • 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)

Inclusion criteria

  • 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)

Exclusion criteria

  • Aged <18 years
  • Unable or unwilling to provide informed consent to participate in the trial
  • No previous infection with VZV (chickenpox)
  • Known allergy to or intolerance of the contents of the RZV vaccine
  • Current pregnancy
  • Population - Group 5. Other (n = 10)

Inclusion criteria

  • Immunosuppressed patient receiving single-agent rapamycin immunosuppression
  • Aged >18 years
  • Previous documented infection with VZV (known infection history or positive VZV IgG result)

Exclusion criteria

  • Aged <18 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)
  • Known allergy to or intolerance of the contents of the RZV vaccine
  • Current pregnancy
  • History of primary immunodeficiency, documented vaccine hypo-responsiveness, or active immunosuppressive therapy
  • Population - Group 6. Dialysis group (n = 30)

Inclusion criteria

  • Kidney failure receiving haemodialysis as kidney replacement therapy
  • Aged >18 years
  • Previous documented infection with VZV (known infection history or positive VZV IgG result)

Exclusion criteria

  • Aged <18 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)
  • Known allergy to or intolerance of the contents of the RZV vaccine
  • Current pregnancy
  • History of primary immunodeficiency or active immunosuppressive therapy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

Australia · 1 center
  • Royal Adelaide Hospital — Adelaide

Identifiers

NCT: NCT06262776 · SIRZOSTER1.01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗