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改良安卡拉痘苗-巴伐利亚北欧疫苗预防猴痘感染的效果:目标试验模拟。

Effectiveness of modified vaccinia Ankara-Bavarian Nordic vaccine against mpox infection: emulation of a target trial.

机构信息

Public Health Ontario, Toronto, ON, Canada.

Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.

出版信息

BMJ. 2024 Sep 11;386:e078243. doi: 10.1136/bmj-2023-078243.

Abstract

OBJECTIVE

To estimate the real world effectiveness of modified vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine against mpox infection.

DESIGN

Emulation of a target trial.

SETTING

Linked databases in Ontario, Canada.

PARTICIPANTS

9803 men aged ≥18 years with a history of being tested for syphilis and a laboratory confirmed bacterial sexually transmitted infection (STI) in the previous year, or who filled a prescription for HIV pre-exposure prophylaxis in the previous year. On each day between 12 June 2022 and 27 October 2022, those who had been vaccinated 15 days previously were matched 1:1 with unvaccinated men by age, geographical region, past HIV diagnosis, number of bacterial STI diagnoses in the previous three years, and receipt of any non-MVA-BN vaccine in the previous year.

MAIN OUTCOME MEASURE

The main outcome measure was vaccine effectiveness ((1-hazard ratio)×100) of one dose of subcutaneously administered MVA-BN against laboratory confirmed mpox infection. A Cox proportional hazards model was used to estimate hazard ratios to compare the rate of laboratory confirmed mpox between the two groups.

RESULTS

3204 men who received the vaccine were matched to 3204 unvaccinated controls. A total of 71 mpox infections were diagnosed, with 0.09 per 1000 person days (95% confidence interval (CI) 0.05 to 0.13) in the vaccinated group and 0.20 per 1000 person days (0.15 to 0.27) in the unvaccinated group over the study period of 153 days. Estimated vaccine effectiveness of one dose of MVA-BN against mpox infection was 58% (95% CI 31% to 75%).

CONCLUSION

The findings of this study, conducted in the context of a targeted vaccination programme and evolving outbreak of mpox, suggest that one dose of MVA-BN is moderately effective in preventing mpox infection.

摘要

目的

评估改良痘苗病毒 Ankara-Bavarian Nordic(MVA-BN)疫苗在现实世界中预防猴痘感染的效果。

设计

目标试验模拟。

设置

加拿大安大略省的相关数据库。

参与者

9803 名年龄≥18 岁的男性,他们在过去一年中曾接受过梅毒检测,或在过去一年中曾被确诊患有细菌性性传播感染(STI),或曾在过去一年中开具过 HIV 暴露前预防处方。在 2022 年 6 月 12 日至 2022 年 10 月 27 日之间的每一天,那些在 15 天前接种过疫苗的人按年龄、地理位置、既往 HIV 诊断、过去三年细菌性 STI 诊断次数以及在过去一年中是否接种过其他非 MVA-BN 疫苗进行 1:1 匹配,与未接种疫苗的男性进行匹配。

主要观察指标

主要观察指标是接种一剂皮下注射 MVA-BN 对实验室确诊猴痘感染的疫苗有效性[(1-风险比)×100]。采用 Cox 比例风险模型估计风险比,以比较两组实验室确诊猴痘的发生率。

结果

3204 名接种疫苗的男性与 3204 名未接种疫苗的对照组相匹配。共有 71 例猴痘感染被确诊,接种组的感染率为每 1000 人日 0.09(95%置信区间 0.05 至 0.13),未接种组为 0.20(0.15 至 0.27),研究期间为 153 天。研究表明,一剂 MVA-BN 对猴痘感染的疫苗有效性估计为 58%(95%置信区间 31%至 75%)。

结论

在有针对性的疫苗接种计划和不断演变的猴痘爆发背景下进行的这项研究结果表明,一剂 MVA-BN 对预防猴痘感染具有中等有效性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7497/11388114/162c5651854e/navc078243.f1.jpg

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