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孟加拉国一组医护人员中新冠病毒突破性感染及疫苗诱导免疫反应的研究方案

Study protocol for COVID-19 breakthrough infections and vaccine-induced immune response among a cohort of healthcare workers, Bangladesh.

作者信息

Hassan Md Zakiul, Basher Ahamed Khairul, Rahman Mohammed Ziaur, Bhuiyan Taufiqur Rahman, Chowdhury Fahmida, Hossain Md Kamal, Rahman Aninda, Islam Md Nazmul, M Duca Lindsey, Kaydos-Daniels Susan Cornelia, A Dahl Benjamin, Qadri Firdausi, Ortiz Nancy

机构信息

Infectious Disease Division, Programme for Emerging Infections, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.

Communicable Disease Control, the Director General of Health Services, Ministry of Health and Family Welfare Government of Bangladesh, Dhaka, Bangladesh.

出版信息

PLoS One. 2024 Dec 31;19(12):e0316121. doi: 10.1371/journal.pone.0316121. eCollection 2024.

Abstract

BACKGROUND

To optimize vaccination strategies, it is useful to detect breakthrough infections and assess vaccine effectiveness in programmatic use. Monitoring emerging SARS-CoV-2 variants and vaccine effectiveness against them is also essential to determine the most effective vaccine options. This study aims to monitor SARS-CoV-2 breakthrough infections, the emergence of new SARS-CoV-2 variants, and host immune response during the peri-infection period of COVID-19. The study will also assess the uptake of the COVID-19 vaccine booster doses, and associated barriers or motivations among healthcare workers (HCWs).

METHODS

Leveraging an existing HCW cohort in Bangladesh, HCWs will be enrolled from purposively selected health facilities from four different administrative divisions across Bangladesh. We captured cohort data on HCW's demographic information, clinical information, COVID-19 illness, and exposure, and vaccination histories for COVID-19. However, no biological specimens were collected for testing during the first phase of the cohort. In the current study, we plan to follow enrolled HCWs biweekly for suspected COVID-19 illness and capture relevant data including illness outcomes. Respiratory swab samples from symptomatic and a subset of asymptomatic HCWs will be tested for SARS-CoV-2 by rRT-PCR and positive samples will undergo Sanger sequencing to identify the SARS-CoV-2 variants of concern (VOCs). We will also perform Whole Genome Sequencing on a subset of SARS-CoV-2 positive samples with low CT values (Ct ≤ 30) to identify emerging SARS-CoV-2 variants. To examine the antibody response, we will collect blood samples from the participants at 12-week intervals for one year. We will use the EUROIMMUN kit and will also perform in-house ELISA to assess host immune factors with Luminex platform.

DISCUSSION

This proposed study will generate useful data on COVID-19 breakthrough infection and the durability of anti-SARS-CoV-2 antibodies among HCWs following vaccination. The findings on booster vaccination intention and uptake will inform government COVID-19 vaccination strategies. Information on circulating and emerging strains of SARS-CoV-2 and vaccine performance against those strains will help understand population-level risks of COVID-19 infection. The study will generate data on facilitators and barriers to COVID-19 booster uptake among HCWs which can inform health communication messaging to improve booster acceptance in this population.

摘要

背景

为优化疫苗接种策略,检测突破性感染并评估疫苗在实际应用中的有效性很有必要。监测新型严重急性呼吸综合征冠状病毒2(SARS-CoV-2)变体以及疫苗对它们的有效性对于确定最有效的疫苗选择也至关重要。本研究旨在监测SARS-CoV-2突破性感染、新型SARS-CoV-2变体的出现以及2019冠状病毒病(COVID-19)感染期间宿主的免疫反应。该研究还将评估COVID-19疫苗加强针的接种情况以及医护人员(HCWs)接种的相关障碍或动机。

方法

利用孟加拉国现有的医护人员队列,将从孟加拉国四个不同行政区有目的地选择的医疗机构中招募医护人员。我们收集了关于医护人员的人口统计学信息、临床信息、COVID-19疾病、暴露情况以及COVID-19疫苗接种史的队列数据。然而,在队列的第一阶段没有收集生物样本进行检测。在当前研究中,我们计划每两周对已招募的医护人员进行随访,以排查疑似COVID-19疾病,并收集包括疾病结局在内的相关数据。有症状和一部分无症状医护人员的呼吸道拭子样本将通过逆转录实时荧光定量聚合酶链反应(rRT-PCR)检测SARS-CoV-2,阳性样本将进行桑格测序以鉴定关注的SARS-CoV-2变体(VOCs)。我们还将对一部分CT值较低(Ct≤30)的SARS-CoV-2阳性样本进行全基因组测序,以鉴定新出现的SARS-CoV-2变体。为检测抗体反应,我们将在一年内每隔12周从参与者中采集血样。我们将使用欧蒙试剂盒,并还将利用Luminex平台进行内部酶联免疫吸附测定(ELISA)来评估宿主免疫因子。

讨论

这项拟议的研究将生成关于COVID-19突破性感染以及医护人员接种疫苗后抗SARS-CoV-2抗体持久性的有用数据。关于加强针接种意愿和接种情况的研究结果将为政府的COVID-19疫苗接种策略提供参考。关于SARS-CoV-2流行和新出现毒株以及针对这些毒株的疫苗性能的信息将有助于了解COVID-19感染的人群层面风险。该研究将生成关于医护人员接种COVID-19加强针的促进因素和障碍的数据,这可为健康宣传信息提供参考,以提高该人群对加强针的接受度。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2dde/11687639/0f7e4c350145/pone.0316121.g001.jpg

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