此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Antibody After COVID-19 Vaccination

2022年1月10日 更新者:Thananda Trakarnvanich、Bangkok Metropolitan Administration Medical College and Vajira Hospital

Antibody Response After COVID-19 Vaccination in Chronic Kidney Disease and Kidney Transplant Patients

Chronic kidney disease (CKD) including patients on dialysis and kidney transplant recipients. represents the special subgroups of patients that required protection during the Severe Coronavirus Disease 2019 (COVID-19) pandemic .Since COVID-19 is associated with severe morbidity and mortality in these particular subgroup of patients, the main strategies is proper and rapid vaccination. CKD patients usually have a reduced immune responses, vaccination in these group of patients usually require higher dosage and more frequent dose since the vaccine response is short-lived and less response especially in dialysis patients5 .In patients with normal renal function,the immunity is durable but with modest declines at 6-8months. One study showed a linear decline in IgG in dialysis patients for up to 3months , but there are otherwise limited data.

Previous reports of the vaccination in CKD patient involved mainly the mRNA vaccines. The recent reports of seroconversion rate dialysis patients receiving two doses of BNT 162b2 vaccine (Pfizer BioNtech) was lower than in control. In Thailand, the main vaccines available are Coronavac (Sinovac Life Science, Beijing, China) and ChadOx1 nCoV-19 (Oxford-Astra Zeneca) which was dispensed all over the country since April 2021. Data of the efficacy and safety of these vaccines in these patient groups is lacking. Therefore, the aim of this study is to measure the antibody and cellular responses in CKD patients including those with dialysis therapy and kidney transplantation and monitor the adverse events after the first and second doses of after vaccination. The incidence rate of Sars-COV2 infection post vaccination was also observed.

研究概览

详细说明

This is a prospective cohort study that included 4 different cohorts i.e CKD ,hemodialysis ( HD), continuous ambulatory peritoneal dialysis (CAPD) , kidney transplant (KT) patients and a control group without kidney failure at Faculty of Medicine, Vajira Hospital,Navamindradhiraj University from June -December 2021. The inclusion criteria were CKD stage 3-5 (eGFR < 60 mL/min/1.73m3), CKD patients receiving HD,CAPD and KT. The participants of the healthy control group consists of volunteer health care workers who had been vaccinated according to the nation vaccination schedule. Participants in both groups needed to be 18-90 years old. The exclusion criteria were allergy to the components of vaccines, unable to receive the vaccine according to the schedule,fever or concomitant serious illnesses and had side effect from the first dose of vaccination. Patients or individuals with prior COVID-19 infection in the past (diagnosed via patients history and serological test for nucleocapsid (NCP) antibody were excluded from the study. The study protocol was approved by the local Ethics Committed and participants were enrolled after written informed consent was obtained. The study who performed in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice. The vaccine used was authorized by the Thai Food and Drug Administration and the Department of Medical Sciences (DMS).

研究类型

观察性的

注册 (实际的)

140

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Bangkok、泰国、10300
        • Faculty of Medicine,Vajira Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 90年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

CKD stage 3-5 and those require renal replacment therapy with HD,CAPD or Kidney trasnplantation

描述

Inclusion Criteria:

  • CKD stage 3-5 (eGFR < 60 mL/min/1.73m3)
  • CKD stage 5 patients receiving HD,CAPD and KT for more than 3 months.
  • The participants of the healthy control group consists of volunteer health care workers who had been vaccinated according to the nation vaccination schedule

Exclusion Criteria:

  • allergy to the components of vaccines
  • unable to receive the vaccine according to the schedule
  • fever or concomitant serious illnesses
  • had side effect from the first dose of vaccination
  • prior COVID-19 infection in the past (diagnosed via patients history and serological test for nucleocapsid (NCP) antibody

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Control
Healthy healthcare workers
The enrolled patients will received COVID-19 vaccine according to the vaccine protocol in Thailand ie The ChAdox-1 nCOV-19 vaccine (day 1, day 84, 12 weeks duration) or Corona vac 2 doses (day 2, day 21, 3 weeks duration) of the study. All the participants underwent blood drawn for antibody and cellular immunity measurement before the final dose of vaccination, with 7 days before first vaccine dose and eight weeks after the second doses
Chronic kidney disease (CKD)
CKD stage 3-5 (eGFR < 60 mL/min/1.73m3)
The enrolled patients will received COVID-19 vaccine according to the vaccine protocol in Thailand ie The ChAdox-1 nCOV-19 vaccine (day 1, day 84, 12 weeks duration) or Corona vac 2 doses (day 2, day 21, 3 weeks duration) of the study. All the participants underwent blood drawn for antibody and cellular immunity measurement before the final dose of vaccination, with 7 days before first vaccine dose and eight weeks after the second doses
Dialysis patients
CKD stage 5 requiring HD
The enrolled patients will received COVID-19 vaccine according to the vaccine protocol in Thailand ie The ChAdox-1 nCOV-19 vaccine (day 1, day 84, 12 weeks duration) or Corona vac 2 doses (day 2, day 21, 3 weeks duration) of the study. All the participants underwent blood drawn for antibody and cellular immunity measurement before the final dose of vaccination, with 7 days before first vaccine dose and eight weeks after the second doses
kidney transplant patients
patients receiving kidney transplantation for more than 3 months
The enrolled patients will received COVID-19 vaccine according to the vaccine protocol in Thailand ie The ChAdox-1 nCOV-19 vaccine (day 1, day 84, 12 weeks duration) or Corona vac 2 doses (day 2, day 21, 3 weeks duration) of the study. All the participants underwent blood drawn for antibody and cellular immunity measurement before the final dose of vaccination, with 7 days before first vaccine dose and eight weeks after the second doses
dialysis patients
CKD patients requring continuos ambulatory peritoneal dialysis
The enrolled patients will received COVID-19 vaccine according to the vaccine protocol in Thailand ie The ChAdox-1 nCOV-19 vaccine (day 1, day 84, 12 weeks duration) or Corona vac 2 doses (day 2, day 21, 3 weeks duration) of the study. All the participants underwent blood drawn for antibody and cellular immunity measurement before the final dose of vaccination, with 7 days before first vaccine dose and eight weeks after the second doses

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Immunogenicity after COVID-19 vaccination
大体时间:Baseline before vaccination
levels of SARS-CoV2 spike S1-specific immunoglobulin (IgG) antibody concentration
Baseline before vaccination
Immunogenicity after COVID-19 vaccination
大体时间:The second dose of vaccination
levels of SARS-CoV2 spike S1-specific immunoglobulin (IgG) antibody concentration
The second dose of vaccination
Immunogenicity after COVID-19 vaccination
大体时间:Eight weeks after the second dose of vaccination
levels of SARS-CoV2 spike S1-specific immunoglobulin (IgG) antibody concentration
Eight weeks after the second dose of vaccination
Immunogenicity after COVID-19 vaccination
大体时间:Baseline before vaccination
Viral neutralization test measured by surrogate virus neutralization test (SVNT)
Baseline before vaccination
Immunogenicity after COVID-19 vaccination
大体时间:The second dose of vaccination
Viral neutralization test measured by surrogate virus neutralization test (SVNT)
The second dose of vaccination
Immunogenicity after COVID-19 vaccination
大体时间:Eight weeks after the second dose of vaccination
Viral neutralization test measured by surrogate virus neutralization test (SVNT)
Eight weeks after the second dose of vaccination
Immunogenicity after COVID-19 vaccination
大体时间:Baseline before vaccination
Cellular immunity by interferon gamma level
Baseline before vaccination
Immunogenicity after COVID-19 vaccination
大体时间:The second dose of vaccination
Cellular immunity by interferon gamma level
The second dose of vaccination
Immunogenicity after COVID-19 vaccination
大体时间:Eight weeks after the second dose of vaccination
Cellular immunity by interferon gamma level
Eight weeks after the second dose of vaccination

次要结果测量

结果测量
措施说明
大体时间
rates of adverse events after vaccination
大体时间:28 days
drug allergy ,skin rash,liver toxicity
28 days
the incidence of COVID-19 breakthrough infection after vaccination
大体时间:28 days
number of cases that develop COVID-19 infection after vaccination
28 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年6月1日

初级完成 (实际的)

2021年12月31日

研究完成 (实际的)

2021年12月31日

研究注册日期

首次提交

2021年9月23日

首先提交符合 QC 标准的

2021年9月23日

首次发布 (实际的)

2021年9月27日

研究记录更新

最后更新发布 (实际的)

2022年1月11日

上次提交的符合 QC 标准的更新

2022年1月10日

最后验证

2022年1月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

The data that present in this study will be deposited in Mendeley osother data repository sited as appropriate

IPD 共享时间框架

after publication is accepted and indefinitely

IPD 共享访问标准

additional data related to this paper may be requested from the corresponding author

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅