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Clinical Trials in Australia / NCT06262776
Recruiting Not applicable

Safety and Immunogenicity of Recombinant Zoster Vaccine for Transplant Recipients

NCT06262776 · tracked via the Priya Life Science Australia tracker
Phase
Not applicable
Started
2024-03-20
Last updated
2026-04-09

Condition(s) studied

ImmunosuppressionVaccine Response Impaired

Investigational drug(s) / intervention(s)

Recombinant zoster vaccine adjuvanted (SHINGRIX) →

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

Study 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. 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
1. 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 2. 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 3. 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 4. 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Royal Adelaide Hospital Adelaide South Australia Recruiting

More Central Adelaide Local Health Network Incorporated trials in Australia

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06262776 on ClinicalTrials.gov ↗ ← All trials in Australia