评估在 COVID-19 大流行期间接种卡介苗对老年人非特异性感染保护的效果：随机临床试验。

IF 14.3 1区医学 Q1 INFECTIOUS DISEASES Journal of Infection Pub Date : 2024-10-17 DOI:10.1016/j.jinf.2024.106319

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引用次数: 0

摘要

目的：卡介苗（Bacillus Calmette-Guérin，BCG）可诱导非特异性保护，预防无关感染。我们测试了卡介苗对丹麦老年人感染风险的影响：单盲随机对照试验，包括 1,676 名年龄大于 65 岁的志愿者。参与者按 1:1 的比例随机接受卡介苗或安慰剂治疗，并随访 12 个月。主要结果是急性感染导致医疗接触。次要结果是经证实的 SARS-CoV-2 感染、自我报告的呼吸道症状和全因住院。数据采用 Cox 回归模型进行分析，估算出危险比（HR）和 95% 的置信区间（CI）：卡介苗和安慰剂的急性感染发病率分别为每100人年52.1例和58.2例（HR=0.89，95% CI=0.78-1.02）。卡介苗对 SARS-CoV-2 感染（0.97，0.75-1.26）或全因住院（1.10，0.80-1.50）没有影响，但卡介苗与更多呼吸道症状（1.21，1.10-1.33）相关。卡介苗降低了 75 岁参与者的急性感染发病率（1.14，0.88-1.47）。在入组前接种过 COVID-19 疫苗的参与者中，卡介苗与较低的急性感染发病率相关（0.65，0.50-0.85）：卡介苗总体上并未降低丹麦老年人的急性感染风险，但其效果因年龄组和接种 COVID-19 疫苗而异：试验注册：ClinicalTrials.gov（NCT04542330）和欧盟临床试验注册（EudraCT 编号 2020-003904-15）。摘要：在一项针对丹麦老年人的随机临床试验中，卡介苗接种并未降低急性感染的总体风险，但卡介苗接种可降低参与者的风险。

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Evaluating the effect of BCG vaccination for non-specific protection from infection in senior citizens during the COVID-19 pandemic: A randomised clinical trial

Objectives

The Bacillus Calmette-Guérin (BCG) vaccine may induce non-specific protection against unrelated infections. We tested the effect of BCG on the risk of infections among Danish senior citizens.

Methods

Single-blinded randomised controlled trial including 1676 volunteers >65 years. Participants were randomised 1:1 to BCG or placebo and followed for 12 months. The primary outcome was acute infection leading to medical contact. Secondary outcomes were verified SARS-CoV-2 infection, self-reported respiratory symptoms, and all-cause hospitalisation. Data was analysed using Cox regression models, estimating hazard ratios (HR) with 95% confidence intervals (CI).

Results

The incidence of acute infection was 52.1 and 58.2 per 100 person-years for BCG and placebo, respectively (HR=0.89, 95% CI=0.78–1.02). There was no effect of BCG on SARS-CoV-2 infections (0.97, 0.75–1.26) or all-cause hospitalisations (1.10, 0.80–1.50), but BCG was associated with more respiratory symptoms (1.21, 1.10–1.33). BCG reduced the incidence of acute infections among participants <75 years (0.82, 0.70–0.95) but not among those >75 years (1.14, 0.88–1.47). In participants, who were COVID-19 vaccinated before enrolment, BCG was associated with lower incidence of acute infections (0.65, 0.50–0.85).

Conclusion

BCG did not reduce risk of acute infections among Danish seniors overall, but the effect was modified by age group and COVID-19 vaccination.

Trial registration

ClinicalTrials.gov (NCT04542330) and EU Clinical Trials Register (EudraCT number 2020-003904-15). Full trial protocol is available at ClinicalTrials.gov.

Summary

In a randomised clinical trial among Danish senior citizens, BCG vaccination did not reduce the overall risk of acute infection, but BCG was associated with reduced risk in participants <75 years and participants who received COVID-19 vaccines prior to enrolment.

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来源期刊

Journal of Infection 医学-传染病学

CiteScore

45.90

自引率

3.20%

发文量

475

审稿时长

16 days

期刊介绍： The Journal of Infection publishes original papers on all aspects of infection - clinical, microbiological and epidemiological. The Journal seeks to bring together knowledge from all specialties involved in infection research and clinical practice, and present the best work in the ever-changing field of infection. Each issue brings you Editorials that describe current or controversial topics of interest, high quality Reviews to keep you in touch with the latest developments in specific fields of interest, an Epidemiology section reporting studies in the hospital and the general community, and a lively correspondence section.