Safety and Immunogenicity of Recombinant Zoster Vaccine for Transplant Recipients
Recruiting now · Not applicable
Conditions studied: Immunosuppression, Vaccine Response Impaired
In brief
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.
Key facts
- Study ID
- NCT06262776
- Run by
- Central Adelaide Local Health Network Incorporated
- People needed
- 160
- Starts
- 2024-03-20
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-04-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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)
- 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
Where it is running
- Royal Adelaide Hospital — Adelaide, South Australia, Australia (enrolling)
Full record on ClinicalTrials.gov
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