Safety and Immunogenicity of Recombinant Zoster Vaccine for Transplant Recipients

Официальное название

Safety and Immunogenicity of Recombinant Zoster Vaccine for Transplant Recipients (SIR ZOSTER)

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Functional T cell memory [Срок оценки: 3 weeks following second vaccine dose]

Вторичные конечные точки (6)

• Frequency of virus specific T cells [Срок оценки: 3 weeks and 52 weeks following second vaccine dose]
• Magnitude of antibody response [Срок оценки: 3 weeks and 52 weeks following second vaccine dose]
• Concentration of post-vaccination circulating cytokines [Срок оценки: 3 weeks following second vaccine dose]
• Frequency of polyfunctional T cells [Срок оценки: 3 weeks and 52 weeks following second vaccine dose]
• Magnitude of vaccine-induced cross-protective antiviral responses [Срок оценки: 3 weeks and 52 weeks following second vaccine dose]
• Frequency of virus-specific T stem cell memory compared to baseline [Срок оценки: 3 weeks and 52 weeks following second vaccine dose]

Критерии участия

• Population - Group 1. Healthy co-habitants (n = 30)

Критерии включения

• Household co-habitant of transplant recipient in trial
• Aged >50 years
• Previous documented infection with VZV (known infection history or positive VZV IgG result)

Критерии исключения

• 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 2-4. Transplant recipients (n = 90)

Критерии включения

• 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)

Критерии исключения

• 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 5. Other (n = 10)

Критерии включения

• Immunosuppressed patient receiving single-agent rapamycin immunosuppression
• Aged >18 years
• Previous documented infection with VZV (known infection history or positive VZV IgG result)

Критерии исключения

• 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 6. Dialysis group (n = 30)

Критерии включения

• Kidney failure receiving haemodialysis as kidney replacement therapy
• Aged >18 years
• Previous documented infection with VZV (known infection history or positive VZV IgG result)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Австралия · 1 центр

• Royal Adelaide Hospital — Adelaide

Идентификаторы

NCT: NCT06262776 · SIRZOSTER1.01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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