NCT06262776招募中不适用
Safety and Immunogenicity of Recombinant Zoster Vaccine for Transplant Recipients (SIR ZOSTER)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Functional T cell memory
研究概览
简要总结
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:
- Are there differences in vaccination immunological responses in transplant patients on different immunosuppression regimens?
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Population - Group
- •Healthy co-habitants (n = 30)
- •Inclusion criteria:
- •Household co-habitant of transplant recipient in trial
- •Aged >50 years
- •Previous documented infection with VZV (known infection history or positive VZV IgG result)
排除标准
- •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-
- •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
- •Other (n = 10)
- •Inclusion criteria:
- •Immunosuppressed patient receiving single-agent rapamycin immunosuppression
- •Aged >18 years
- •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
- •Known allergy to or intolerance of the contents of the RZV vaccine
- •No previous infection with VZV (chickenpox)
- •Known allergy to or intolerance of the contents of the RZV vaccine
- •Current pregnancy
- •History of primary immunodeficiency, documented vaccine hypo-responsiveness, or active immunosuppressive therapy
- •Population - Group
- •Dialysis group (n = 30)
- •Inclusion criteria:
- •Kidney failure receiving haemodialysis as kidney replacement therapy
- •Aged >18 years
- •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
- •Known allergy to or intolerance of the contents of the RZV vaccine
- •No previous infection with VZV (chickenpox)
- •Known allergy to or intolerance of the contents of the RZV vaccine
- •Current pregnancy
- •History of primary immunodeficiency or active immunosuppressive therapy
研究组 & 干预措施
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.
干预措施: Recombinant zoster vaccine adjuvanted (SHINGRIX) (Biological)
结局指标
主要结局
Functional T cell memory
时间窗: 3 weeks following second vaccine dose
ELISpot measurement of interferon gamma spot-forming units following 18-hour stimulation of peripheral blood mononuclear cells with Zoster gE protein-derived peptide array
次要结局
- Frequency of polyfunctional T cells(3 weeks and 52 weeks following second vaccine dose)
- Frequency of virus specific T cells(3 weeks and 52 weeks following second vaccine dose)
- Magnitude of antibody response(3 weeks and 52 weeks following second vaccine dose)
- Concentration of post-vaccination circulating cytokines(3 weeks following second vaccine dose)
- Frequency of virus-specific T stem cell memory compared to baseline(3 weeks and 52 weeks following second vaccine dose)
- Magnitude of vaccine-induced cross-protective antiviral responses(3 weeks and 52 weeks following second vaccine dose)
研究者
Matthew Tunbridge
Principal Investigator
Central Adelaide Local Health Network Incorporated
研究点 (1)
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