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| Name | Class |
|---|---|
| National Health and Medical Research Council, Australia | OTHER |
| University of Adelaide | OTHER |
| Royal Prince Alfred Hospital, Sydney, Australia | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccination group | Experimental | All participants will receive the assigned intervention, a 2-dose course of Zoster recombinant adjuvanted vaccine. Study participants will include kidney transplant recipients receiving specific immunosuppressive medications, and non-immunosuppressed household cohabitants, with comparisons made in magnitude of vaccine response. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant zoster vaccine adjuvanted (SHINGRIX) | Biological | 2 doses of 0.5mL recombinant zoster vaccine adjuvanted intramuscular injection at week 0 and week 8. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Magnitude of antibody response |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of shingles | Incidence of shingles in the study cohort from 3 weeks post-vaccination to 12 month follow-up | 12 months |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
Population - Group 1. Healthy co-habitants (n = 30)
Inclusion criteria:
Exclusion criteria:
Population - Groups 2-4. Transplant recipients (n = 90)
Inclusion criteria:
Organ transplant recipients
-- Specific immunosuppression regimen
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:
Population - Group 5. Other (n = 10)
Inclusion criteria:
Exclusion criteria:
Population - Group 6. Dialysis group (n = 30)
Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick T Coates, MBBS, FRACP, PhD | Contact | 70740000 | Toby.Coates@sa.gov.au | |
| Griffith B Perkins, PhD | Contact | 70740000 | Griffith.Perkins@adelaide.edu.au |
| Name | Affiliation | Role |
|---|---|---|
| Patrick T Coates, FRACP | Central and Northern Adelaide Renal and Transplantation Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Adelaide Hospital | Recruiting | Adelaide | South Australia | 5000 | Australia |
Identifiable data will not be publicly released, however, de-identified data will be made available in combination with publication of study results either as supplementary material or on public repository. Study protocol and statistical analysis plan will be made available as supplementary material with publication of results.
Data will be made available following publication of trial results, and will be available in perpetuity.
Trial results and supporting information outlined above will be made available through open access publishing.
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Anti Varicella zoster gE Immunoglobulin M (IgM) and IgG antibody titres compared to baseline |
| 3 weeks and 52 weeks following second vaccine dose |
| Concentration of post-vaccination circulating cytokines | Post-vaccination circulating cytokines compared to baseline | 3 weeks following second vaccine dose |
| 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 |
| 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 |
| 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 |
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 |
| 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 |