Impact of the immune system on response to COVID-19 vaccine in allogeneic stem cell recipients - Cov-Allo

CHU de Liège0 个研究点目标入组 70 人开始时间: 2021年2月19日最近更新: 2021年10月8日

适应症

试验速览

暂无简介。

•Full protocol (3 vaccines, n=50)
•- prior allogeneic hematopoietic stem cell transplantation 3 months to 5 years earlier (any donor type); patients > 5 years are also eligible if they are still on systemic immunosuppressive treatment.
•- age> or = 18years at inclusion.
•- written informed consent
•Third dose vaccine only (n=20)
•- Prior allogeneic hematopoietic stem cell transplantation 3 months to 5 years earlier (any donor type); patients > 5 years are also eligible if they are still on systemic immunosuppressive treatment.
•- age > or = 18years at inclusion.
•- written informed consent
•- Prior vaccination with 2 doses of the Comirnaty® vaccine after allo-HCT
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•Full protocol (3 vaccines, n=50)
•- HIV seropositivity
•- Pregnancy
•- Active malignant disease at inclusion
•- Current grade III-IV acute GVHD
•- In vitro T-cell depletion of the graft if vaccination within the 6 months after transplantation.
•- Rituximab administration in the 6 months prior to study inclusion
•- Prior documented COVID-19 infection occurring after allo-HCT
•Third dose vaccine only (n=20)
•- HIV seropositivity
•- Pregnancy
•- Active malignant disease at inclusion
•- Current grade III-IV acute GVHD
•- Rituximab administration in the 6 months prior to study inclusion for the third dose
•- Subjects who were not previously vaccinated with a COVID-19 vaccine according to the scheme mentioned above
•- Subjects who already received a third booster dose of a COVID-19 vaccine
•- Prior documented COVID-19 infection occurring after allo-HCT

发起方

CHU de Liège