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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
160
2 doses of 0.5mL recombinant zoster vaccine adjuvanted intramuscular injection at week 0 and week 8.
Royal Adelaide Hospital
Adelaide, South Australia, Australia
RECRUITINGFunctional 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
Time frame: 3 weeks following second vaccine dose
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
Time frame: 3 weeks and 52 weeks following second vaccine dose
Magnitude of antibody response
Anti Varicella zoster gE Immunoglobulin M (IgM) and IgG antibody titres compared to baseline
Time frame: 3 weeks and 52 weeks following second vaccine dose
Concentration of post-vaccination circulating cytokines
Post-vaccination circulating cytokines compared to baseline
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 3 weeks and 52 weeks following second vaccine dose
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