Clinical trial NCT06262776: Safety and Immunogenicity of Recombinant Zoster Vaccine for Kidney Transplant Recipients
Official title: Safety and Immunogenicity of Recombinant Zoster Vaccine for Kidney Transplant Recipients (SIR ZOSTER)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Immunosuppression
Vaccine Response Impaired
Lead sponsor: Central Adelaide Local Health Network Incorporated
Sponsor class: OTHER_GOV
Collaborators: name: National Health and Medical Research Council, Australia
name: University of Adelaide
name: Royal Prince Alfred Hospital, Sydney, Australia
First posted: 2024-02-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to compare responses to Varicella Zoster vaccination between kidney 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 kidney transplant patients on different immunosuppression regimens?
2. Are there differences in vaccination immunological responses between kidney 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: Inclusion Criteria:

* Single organ kidney transplant recipient, currently receiving a specific immunosuppression regimen:

  1. Calcineurin inhibitor (tacrolimus or cyclosporine), antimetabolite (mycophenolate derivative or azathioprine), and oral steroid (n = 30)
  2. Calcineurin inhibitor (tacrolimus or cyclosporine), mTOR inhibitor (sirolimus or everolimus), and oral steroid (n = 30)
  3. mTOR inhibitor (sirolimus or everolimus), antimetabolite (mycophenolate derivative or azathioprine), and oral steroid (n = 30)
* Aged \>18 years
* estimated glomerular filtration rate (GFR) \> 15 mL/min/1.73m2
* Previous documented infection with Varicella zoster (known infection history or positive Varicella zoster IgG result)

OR

* Healthy household cohabitant of kidney transplant recipient enrolled in trial (n = 30)
* Aged \> 50 years
* Previous documented infection with Varicella zoster (known infection history or positive Varicella zoster IgG result)

Exclusion Criteria:

* Unable or unwilling to provide informed consent to participate in the trial
* No previous infection with Varicella zoster (chickenpox)
* Known allergy to or intolerance of the contents of the SHINGRIX vaccine
* Current pregnancy
* For healthy household cohabitants, history of primary immunodeficiency, documented vaccine hypo-responsiveness, or active immunosuppressive therapy

Primary outcomes:
measure: Functional T cell memory
timeFrame: 3 weeks following second vaccine dose
Secondary outcomes:
measure: Frequency of virus specific T cells
timeFrame: 3 weeks and 52 weeks following second vaccine dose
measure: Magnitude of antibody response
timeFrame: 3 weeks and 52 weeks following second vaccine dose
measure: Concentration of post-vaccination circulating cytokines
timeFrame: 3 weeks following second vaccine dose
measure: Frequency of polyfunctional T cells
timeFrame: 3 weeks and 52 weeks following second vaccine dose
measure: Magnitude of vaccine-induced cross-protective antiviral responses
timeFrame: 3 weeks and 52 weeks following second vaccine dose
measure: Frequency of virus-specific T stem cell memory compared to baseline
timeFrame: 3 weeks and 52 weeks following second vaccine dose
Other outcomes:
measure: Incidence of shingles
timeFrame: 12 months
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 12 months
measure: Tolerability of vaccination regimen as assessed by EQ-5D
timeFrame: 3 weeks following second vaccine dose
Locations:
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
Study officials:
affiliation: Central and Northern Adelaide Renal and Transplantation Services
name: Patrick T Coates, FRACP
role: PRINCIPAL_INVESTIGATOR
References: