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卡介苗疫苗减少 COVID-19 大流行期间医护人员缺勤的随机对照试验。

Bacillus Calmette-Guérin vaccine to reduce healthcare worker absenteeism in COVID-19 pandemic, a randomized controlled trial.

机构信息

Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University of Utrecht, Utrecht, the Netherlands.

Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University of Utrecht, Utrecht, the Netherlands; Department of Infectious Diseases, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, the Netherlands.

出版信息

Clin Microbiol Infect. 2022 Sep;28(9):1278-1285. doi: 10.1016/j.cmi.2022.04.009. Epub 2022 Apr 28.

DOI:10.1016/j.cmi.2022.04.009
PMID:35489606
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9046133/
Abstract

OBJECTIVES

The COVID-19 pandemic increases healthcare worker (HCW) absenteeism. The bacillus Calmette-Guérin (BCG) vaccine may provide non-specific protection against respiratory infections through enhancement of trained immunity. We investigated the impact of BCG vaccination on HCW absenteeism during the COVID-19 pandemic.

METHODS

HCWs exposed to COVID-19 patients in nine Dutch hospitals were randomized to BCG vaccine or placebo in a 1:1 ratio, and followed for one year using a mobile phone application. The primary endpoint was the self-reported number of days of unplanned absenteeism for any reason. Secondary endpoints included documented COVID-19, acute respiratory symptoms or fever. This was an investigator-funded study, registered at ClinicalTrials.gov (NCT03987919).

RESULTS

In March/April 2020, 1511 HCWs were enrolled. The median duration of follow-up was 357 person-days (interquartile range [IQR], 351 to 361). Unplanned absenteeism for any reason was observed in 2.8% of planned working days in the BCG group and 2.7% in the placebo group (adjusted relative risk 0.94; 95% credible interval, 0.78-1.15). Cumulative incidences of documented COVID-19 were 14.2% in the BCG and 15.2% in the placebo group (adjusted hazard ratio (aHR) 0.94; 95% confidence interval (CI), 0.72-1.24). First episodes of self-reported acute respiratory symptoms or fever occurred in 490 (66.2%) and 443 (60.2%) participants, respectively (aHR: 1.13; 95% CI, 0.99-1.28). Thirty-one serious adverse events were reported (13 after BCG, 18 after placebo), none considered related to study medication.

CONCLUSIONS

During the COVID-19 pandemic, BCG-vaccination of HCW exposed to COVID-19 patients did not reduce unplanned absenteeism nor documented COVID-19.

摘要

目的

COVID-19 大流行增加了医护人员(HCW)的缺勤率。卡介苗(BCG)疫苗可能通过增强训练有素的免疫来提供针对呼吸道感染的非特异性保护。我们研究了 BCG 疫苗接种对 COVID-19 大流行期间 HCW 缺勤的影响。

方法

在荷兰的 9 家医院中接触 COVID-19 患者的 HCWs 以 1:1 的比例随机分配到 BCG 疫苗或安慰剂组,并通过移动电话应用程序随访一年。主要终点是报告的任何原因的计划外缺勤天数。次要终点包括记录的 COVID-19、急性呼吸道症状或发热。这是一项由研究者资助的研究,在 ClinicalTrials.gov 注册(NCT03987919)。

结果

2020 年 3 月/4 月,共纳入 1511 名 HCWs。中位随访时间为 357 个工作日(四分位距[IQR],351 至 361)。BCG 组计划工作日缺勤率为 2.8%,安慰剂组为 2.7%(调整后的相对风险 0.94;95%可信区间,0.78-1.15)。BCG 组和安慰剂组记录的 COVID-19 的累积发生率分别为 14.2%和 15.2%(调整后的危害比[aHR]0.94;95%置信区间[CI],0.72-1.24)。分别有 490(66.2%)和 443(60.2%)名参与者首次报告急性呼吸道症状或发热(aHR:1.13;95%CI,0.99-1.28)。报告了 31 例严重不良事件(BCG 后 13 例,安慰剂后 18 例),均认为与研究药物无关。

结论

在 COVID-19 大流行期间,对接触 COVID-19 患者的 HCW 进行 BCG 疫苗接种并未减少计划外缺勤或记录的 COVID-19。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/73d8/9046133/a4ae66300eaf/gr2_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/73d8/9046133/ad6409c01f4a/gr1_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/73d8/9046133/a4ae66300eaf/gr2_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/73d8/9046133/ad6409c01f4a/gr1_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/73d8/9046133/a4ae66300eaf/gr2_lrg.jpg

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