NCT06262776 Safety and Immunogenicity of Recombinant Zoster Vaccine for Transplant Recipients
| NCT ID | NCT06262776 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Central Adelaide Local Health Network Incorporated |
| Condition | Immunosuppression |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2024-03-20 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2024-03-20 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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 Criteria
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
Contact & Investigator
Patrick T Coates, FRACP
PRINCIPAL INVESTIGATOR
Central and Northern Adelaide Renal and Transplantation Services
Frequently Asked Questions
Who can join the NCT06262776 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Immunosuppression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06262776 currently recruiting?
Yes, NCT06262776 is actively recruiting participants. Contact the research team at Toby.Coates@sa.gov.au for enrollment information.
Where is the NCT06262776 trial being conducted?
This trial is being conducted at Adelaide, Australia.
Who is sponsoring the NCT06262776 clinical trial?
NCT06262776 is sponsored by Central Adelaide Local Health Network Incorporated. The principal investigator is Patrick T Coates, FRACP at Central and Northern Adelaide Renal and Transplantation Services. The trial plans to enroll 160 participants.