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基于社区的前瞻性队列血清诺如病毒监测:研究方案。

Serological surveillance of noroviruses in a community-based prospective cohort: a study protocol.

机构信息

Department of Epidemiology,Guangdong Provincial Key Laboratory of Tropical Disease Research, School of Public Health, Southern Medical University, Guangzhou, Guangdong, China.

School of Traditional Chinese Medicine, Southern Medical University, Guangzhou, Guangdong, China.

出版信息

BMJ Open. 2021 Mar 4;11(3):e043228. doi: 10.1136/bmjopen-2020-043228.

Abstract

INTRODUCTION

Noroviruses are the leading cause of viral acute gastroenteritis affecting all age groups. Since 2014, the previous rarely reported GII.P17-GII.17 and recombinant GII.P16-GII.2 norovirus emerged, replacing GII.4 predominant genotype, causing increased outbreaks in China and other countries. Meanwhile, GII.4/2012 Sydney strain has re-emerged as the dominant variant in many places in 2015-2018. The role of herd immunity as the driving force during these new emerging or re-emerging noroviruses is poorly defined. Serological surveillance studies on community-based prospective cohort on norovirus are highly needed.

METHODS AND ANALYSES

This study will include 1000 out of 9798 participants aged 18 years and above from Caofeidian district, Tangshan city, northern China. Baseline data on sociodemographic characteristics and blood samples were collected in 2013-2014. Blood collection will be replicated annually throughout the cohort until 2023. Saliva samples were also collected in 2016. The seroprevalence and seroincidence of blockade antibodies against norovirus genotypes of GII.P17-GII.17, GII.P16-GII.2, the re-emerged GII.4/2012 and potential novel pandemic variants will be evaluated by ELISA. Associations between genotype blockade antibodies and sociodemographic factors and human histo-blood group antigens will be evaluated using univariate and multivariate analysis. The dynamics of herd immunity duration will be estimated in this longitudinal surveillance.

ETHICS AND DISSEMINATION

The study has been approved by the Ethical Committees of the Staff Hospital of Jidong oil-field of China National Petroleum Corporation. This study will provide insight into the seroprevalence and seroincidence of noroviruses, and their relationships with sociodemographic characteristics and genetic susceptibility. It will also explain herd immunity of the emerged and re-emerged genotypes or variants. The study will further enable an understanding of the mechanism driving the replacement of norovirus genotypes. Research findings will be disseminated in peer-reviewed journals and at scientific meetings.

摘要

简介

诺如病毒是导致所有年龄段人群病毒性急性肠胃炎的主要原因。自 2014 年以来,以前很少报道的 GII.P17-GII.17 和重组 GII.P16-GII.2 诺如病毒出现,取代了 GII.4 主要基因型,导致中国和其他国家的疫情增加。与此同时,GII.4/2012 悉尼株在 2015-2018 年的许多地方再次成为主要变异株。在这些新出现或再次出现的诺如病毒中,群体免疫作为驱动力的作用还没有得到明确的定义。非常需要对社区为基础的前瞻性队列进行诺如病毒血清学监测研究。

方法和分析

本研究将包括来自中国北方唐山市曹妃甸区的 9798 名 18 岁及以上的 1000 名参与者。2013-2014 年收集了社会人口统计学特征和血液样本的基线数据。整个队列将在 2023 年之前每年重复采血。2016 年还采集了唾液样本。通过 ELISA 评估 GII.P17-GII.17、GII.P16-GII.2、重新出现的 GII.4/2012 和潜在新型大流行变异株的诺如病毒基因型的阻断抗体的血清流行率和血清发生率。使用单变量和多变量分析评估基因型阻断抗体与社会人口统计学因素和人类组织血型抗原之间的关系。在这项纵向监测中,将估计群体免疫持续时间的动态。

伦理和传播

该研究已获得中国石油天然气集团公司冀东油田职工医院伦理委员会的批准。本研究将深入了解诺如病毒的血清流行率和血清发生率,及其与社会人口统计学特征和遗传易感性的关系。它还将解释已出现和再次出现的基因型或变异体的群体免疫。该研究将进一步阐明驱动诺如病毒基因型更替的机制。研究结果将发表在同行评议的期刊和科学会议上。

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