Antibody Response After COVID-19 Vaccination in Chronic Kidney Disease and Kidney Transplant Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Immunogenicity after COVID-19 vaccination
研究概览
简要总结
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.
详细描述
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 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Immunogenicity after COVID-19 vaccination
时间窗: Eight weeks after the second dose of vaccination
Cellular immunity by interferon gamma level
次要结局
- the incidence of COVID-19 breakthrough infection after vaccination(28 days)
- rates of adverse events after vaccination(28 days)
研究者
Thananda Trakarnvanich
Associate Professor
Bangkok Metropolitan Administration Medical College and Vajira Hospital
