Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06262776
Other study ID # SIRZOSTER1.01
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 2024
Est. completion date November 2026

Study information

Verified date February 2024
Source Central Adelaide Local Health Network Incorporated
Contact Matthew J Tunbridge, FRACP
Phone 70740000
Email Matthew.Tunbridge@sa.gov.au
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date November 2026
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Central Adelaide Local Health Network Incorporated National Health and Medical Research Council, Australia, Royal Prince Alfred Hospital, Sydney, Australia, University of Adelaide

Outcome

Type Measure Description Time frame Safety issue
Other Incidence of shingles Incidence of shingles in the study cohort from 3 weeks post-vaccination to 12 month follow-up 12 months
Other Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 Safety of two-dose Zoster recombinant vaccine adjuvanted as measured by reported adverse events following immunisation using CTCAE v4.0 1 and 3 weeks after each vaccination, and 12 months after vaccination. 12 months
Other Tolerability of vaccination regimen as assessed by EQ-5D Tolerability of two-dose Zoster recombinant vaccine adjuvanted as measured by quality of life questionnaire EuroQol-5 dimensional (EQ-5D) questionnaire at baseline and 3 weeks after second vaccine dose. This questionnaire assesses quality of life rated on a scale of 0 (worst) to 100 (best), and assesses functional capacity rated on a scale of 0 (best) to 5 (worst) across 5 domains: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. 3 weeks following second vaccine dose
Primary Functional T cell memory ELISpot measurement of interferon gamma spot-forming units following 18-hour stimulation of peripheral blood mononuclear cells with Zoster gE protein-derived peptide array 3 weeks following second vaccine dose
Secondary Frequency of virus specific T cells Change in frequency of CD8+ Zoster gE protein-specific T cells identified by flow cytometry as CD8+CD134+CD69+ following 24-hour stimulation with a gE protein-derived peptide array 3 weeks and 52 weeks following second vaccine dose
Secondary Magnitude of antibody response Anti Varicella zoster gE Immunoglobulin M (IgM) and IgG antibody titres compared to baseline 3 weeks and 52 weeks following second vaccine dose
Secondary Concentration of post-vaccination circulating cytokines Post-vaccination circulating cytokines compared to baseline 3 weeks following second vaccine dose
Secondary Frequency of polyfunctional T cells Change in frequency of Zoster gE protein-specific polyfunctional T cells identified by flow cytometry intracellular cytokine staining (interferon-gamma, interleukin-2, tumour necrosis factor) following 24-hour stimulation with a gE protein-derived peptide array. 3 weeks and 52 weeks following second vaccine dose
Secondary Magnitude of vaccine-induced cross-protective antiviral responses T cells will be investigated for cross-protective herpesviridae responses using interferon gamma ELISpot compared to baseline following 24-hour stimulation with a gE protein-derived peptide array. 3 weeks and 52 weeks following second vaccine dose
Secondary Frequency of virus-specific T stem cell memory compared to baseline Frequency of Zoster gE protein-specific T stem cell memory (Tscm) will be determined by flow cytometry based on expression of T cell phenotypic markers (CD27+CD45RA+CD95+) on activation-induced marker-positive CD4 and CD8 T cells 3 weeks and 52 weeks following second vaccine dose
See also
  Status Clinical Trial Phase
Recruiting NCT05060991 - Impact of Immunosuppression Adjustment on COVID-19 Vaccination Response in Kidney Transplant Recipients Phase 4
Completed NCT02833805 - NMA Haplo or MUD BMT for Newly Diagnosed Severe Aplastic Anemia Phase 2
Completed NCT01252537 - Immunosuppression in HIV-infected Patients With Tuberculosis in Ethiopia N/A
Completed NCT00621699 - Pharmacokinetic Drug Interaction Between Ezetimibe and Tacrolimus After Single Dose Administration in Healthy Subjects Phase 1
Completed NCT01678937 - Immune Tolerance and Alloreactivity in Liver Transplant Recipients on Different Monotherapy Immunosuppressive Agents N/A
Completed NCT00788021 - Protective Immunity Project 01 N/A
Active, not recruiting NCT00166842 - Sirolimus Blood Concentrations on Conversion From Oral Solution to Tablets Phase 4
Recruiting NCT05616130 - Pathological Myeloid Activation After Sepsis and Trauma
Completed NCT03117192 - Zinc Supplementation on Cellular Immunity in Thalassemia Major Phase 4
Recruiting NCT01568697 - Oral Bacteria and Immune System Problems Involved in Gum Disease (Periodontitis)
Not yet recruiting NCT06024226 - Role of MDSCs and Cancer Stem Cells and Their Cross Talks in NSCLC
Not yet recruiting NCT04961229 - Booster Dose of COVID-19 Vaccine for Kidney Transplant Recipients Without Adequate Humoral Response Phase 4
Completed NCT03139565 - High Dose vs. Standard Influenza Vaccine in Adult SOT Phase 3
Completed NCT02547753 - Dental Extractions Among Renal Transplant Recipients
Completed NCT01702207 - Evaluation Of Switching From Twice Daily Tacrolimus To Once Daily Formulation On Cardiovascular Risk Phase 4
Completed NCT00626808 - A Post Marketing Evaluation of the Effectiveness of FluMist Risk Minimization Plan in Children Phase 4
Completed NCT00419575 - Renal Transplantation With Immune Monitoring N/A
Completed NCT00783380 - Influenza Vaccination in Immunocompromized Patients Phase 4
Completed NCT04835948 - Efficacy of Single Dose Anti-thymocyte Globulin in the Modulation of T Lymphocytes in Kidney Transplantation
Recruiting NCT05043870 - Combined Immunosuppression for Pediatric Crohn's Disease Phase 4