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临床试验/NCT06307808
NCT06307808尚未招募不适用

Viral Immunity in TrAnsplanted Patients Depending on iMmunosupressIon

University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
66
试验地点
1
主要终点
Titer of anti-HBs ELISA antibody

研究概览

简要总结

Solid Organ Transplantation (SOT) is made possible by the use of a lifelong immunosuppressive treatment. This treatment limits the response of the immune system, enabling long-term survival of the transplanted organ, but also leading to weaker anti-infectious responses.

In this study, we will compare the response to a booster Hepatitis B vaccination (HBV) in SOT patients, either after kidney or liver transplantation. We will also compare the immune response depending on the immunosuppressive treatment.

In order to provide a detailed picture of the immune response, we will investigate the usual serological response (anti-HBs antibodies), but also the cellular memory (both T and B) using ELISpot assays and flow-cytometry, over a 6 months period following booster vaccination.

详细描述

Solid Organ Transplantation (SOT) is the reference treatment for end stage kidney disease (Kidney Transplantation, KT) and liver failure (Liver Transplantation, LT). As of 2023, an immunosuppressive treatment remains mandatory for long-term graft survival. This treatment translates into a weaker response to vaccines. The recent example of Severe Acute Respiratory Syndrom (SARS) - Coronavirus (CoV), SARS-CoV-2, showed different vaccinal responses depending on the immunosuppressive drug, comparing belatacept- to tacrolimus-based immunosuppression.

Hepatitis B virus (HBV)-vaccination is recommended in chronic kidney failure and liver failure. However, post-transplantation, a loss of HBV seroprotection is seen in ~ 30 % of the patients. A booster HBV vaccine dose is recommended in such case, but the evaluation of the response to this booster dose is limited.

In the Viral Immunity in TrAnsplanted patients depending on iMmunosupressIoN (VITAMIN) study, investigators will investigate the effect of a HBV-vaccine booster on the immune system, comparing KT recipients treated with Belatacept with KT and LT recipients treated with Tacrolimus. The VITAMIN study is a prospective observational study recruiting KT and LT recipients from the time of a booster HBV vaccine injection and over the following 6 months. The idea is to take advantage of this very particular sensitizing event, at a defined timepoint, to investigate the immune response to HBV through vaccination. Investigators will focus on comparing the immunological state before and after vaccination, in kidney and liver transplant recipients receiving immunosuppression.

The immunological state will be described through 1/ the antibody response, 2/ its phenotype (both exploring the T cell compartment and the B cell compartment, including memory B cells, using flow cytometry) and 3/ its functional response (through the ELISpot assessment of the T response against HBV HBs antigen). Sequential blood samples will be taken, using Peripheral Blood Monocytic Cells (PBMC). Also, investigators will focus on HBV-specific memory B cells, to detect potential antibody secreting cells. This project will provide a longitudinal picture of all immune compartments stimulated by HBV vaccination. This longitudinal picture will be compared between tacrolimus-treated KT and LT recipients and belatacept-treated KT recipients.

The main objective is to compare the serological response (anti-HBs antibodies) between tacrolimus- and belatacept-treated patients. The secondary objective is to describe and compare the phenotype and functional T and B responses between tacrolimus- and belatacept-treated patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Kidney or liver transplant recipients
  • Grenoble University Hospital regular follow-up
  • Tacrolimus or belatacept treated
  • Clinical indication for HBV booster vaccination

排除标准

  • Pregnancy or lactating woman
  • History of HBV infection (either anti-Hepatitis B capside antigen (HBc), positivity or HBV-DNA positivity)

研究组 & 干预措施

Kidney transplant recipients, tacrolimus treated

Prevalent kidney transplant recipients, receiving tacrolimus as main immunosuppresant

干预措施: Tacrolimus (Drug)

Liver transplant recipients, tacrolimus treated

Prevalent liver transplant recipients, receiving tacrolimus as main immunosuppressant

干预措施: Tacrolimus (Drug)

Kidney transplant recipients, belatacept treated

Prevalent kidney transplant recipients, receiving belatacept as main immunosuppressant

干预措施: Belatacept (Drug)

结局指标

主要结局

Titer of anti-HBs ELISA antibody

时间窗: From enrollment to 6 months after inclusion

Anti-HBs HBV serological response

次要结局

  • Number of anti-HBs memory B cells(From enrollment to 6 months post-enrollment)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (1)

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