心血管危险因素患者的 SARS-CoV-2 体液免疫反应:社区队列研究方案。

SARS-CoV-2 humoral immune response in patients with cardiovascular risk factors: the COmmunity Cohort Study protocol.

机构信息

Escuela de Medicina, Universidad de Santiago de Chile, Santiago de Chile, Chile

Escuela de Medicina, Universidad de Santiago de Chile, Santiago de Chile, Chile.

出版信息

BMJ Open. 2022 May 19;12(5):e061345. doi: 10.1136/bmjopen-2022-061345.

Abstract

INTRODUCTION

The COmmunity Cohort Study aims to determine, after natural exposure to SARS-CoV-2 or anti-SARS-CoV-2 vaccines deployed in Chile to prevent COVID-19 in the context of the current pandemic, the strength and duration of detectable neutralising antibodies in adult ambulatory primary care patients with cardiovascular risk factors.

METHODS AND ANALYSIS

We will set up a community-based longitudinal, prospective cohort study. The study will be conducted in two public outpatient clinics located in the southern district of Santiago, Chile. We expect to begin recruitment in the second quarter of 2022. Each patient will be followed up for at least 1 year after inclusion in the cohort. The eligible population will be adult patients registered in the Cardiovascular Health Programme. Exposure in this study is defined as any event where participants have contact with SARS-CoV-2 antigens from natural exposure or vaccination. The primary outcomes are seroconversion and strength and duration of the neutralising IgG antibodies to SARS-CoV-2. Secondary outcomes are any COVID-19-related event or intercurrent morbidities or death. Data will be collected by extracting serial blood samples and administering a questionnaire at the first face-to-face contact and monthly follow-up time points. The sample size estimated for this study is 1060. We will characterise the cohort, determine the seroprevalence rate of neutralising antibodies at baseline and determine the rates of antibody decline using a longitudinal mixed-effects model.

ETHICS AND DISSEMINATION

The Scientific Ethics Committee of the South Metropolitan Health Care Service approved the study protocol (Memorandum No 191/2021). We will present the results in two peer-reviewed publications and national and international professional and academic meetings. We will organise seminars with relevant stakeholders and hold town hall meetings with the local community. We will set up a COmmunity Cohort Study website at www.communitystudy.cl to disseminate the study purpose, research team and milestones.

摘要

简介

社区队列研究旨在确定在当前大流行背景下,智利部署的 SARS-CoV-2 或抗 SARS-CoV-2 疫苗自然暴露后,在具有心血管风险因素的成年门诊初级保健患者中,可检测到的中和抗体的强度和持续时间。

方法和分析

我们将建立一个基于社区的纵向、前瞻性队列研究。该研究将在智利圣地亚哥南部地区的两个公立门诊诊所进行。我们预计将在 2022 年第二季度开始招募。每个患者将在队列中纳入后至少随访 1 年。合格人群将是注册在心血管健康计划中的成年患者。本研究中的暴露定义为参与者通过自然暴露或接种疫苗与 SARS-CoV-2 抗原接触的任何事件。主要结局是血清转化率以及 SARS-CoV-2 中和 IgG 抗体的强度和持续时间。次要结局是任何与 COVID-19 相关的事件或并发疾病或死亡。通过在第一次面对面接触时提取连续的血液样本和进行问卷调查以及每月随访时间点收集数据。这项研究估计的样本量为 1060 人。我们将对队列进行特征描述,确定基线时中和抗体的血清阳性率,并使用纵向混合效应模型确定抗体下降率。

伦理和传播

南都会区卫生保健服务的科学伦理委员会批准了该研究方案(备忘录第 191/2021 号)。我们将在两篇同行评议的出版物以及国家和国际专业和学术会议上展示研究结果。我们将与相关利益攸关方组织研讨会,并与当地社区举行市政厅会议。我们将在 www.communitystudy.cl 上建立一个社区队列研究网站,以传播研究目的、研究团队和里程碑。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/26cc/9121110/44bd23bf53a4/bmjopen-2022-061345f01.jpg

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