Език: EN EN
← Назад към резултатите
Набира участници Не е приложимо NCT06262776

Safety and Immunogenicity of Recombinant Zoster Vaccine for Transplant Recipients

Не е приложима фаза (напр. обсервационно)
Заболявания: Immunosuppression Vaccine Response Impaired

Спонсор: Central Adelaide Local Health Network Incorporated

Налично на: БГ
Обобщение
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.
Кой може да участва
1. Population - Group 1. 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) Exclusion criteria: * 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 2. Population - Groups 2-4. 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 3. Population - Group 5. 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 4. Population - Group 6. 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
Места на провеждане 1
Австралия (1)
Royal Adelaide Hospital
Adelaide , South Australia
Patrick T Coates, PhD FRACP
Технически детайли
Статус
Набира участници
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
20.03.2024
Крайна дата
01.12.2027
Регистрационен номер
NCT06262776
Източник
anzctr
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.