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尼尔塞维马布与RSVpreF疫苗用于新生儿呼吸道同胞病毒相关的住院治疗

Marie-Joelle Jabagi¹, Marion Bertrand¹, Amélie Gabet¹

¹French National Agency for Medicines and Health Products Safety and French National Health Insurance (EPI-PHARE), Saint-Denis, France.

|December 22, 2025

概括

与母体接种RSV预注射F蛋白 (RSVpreF) 疫苗相比,使用nirsevimab对婴儿的被动免疫显示出更低的呼吸道同胞病毒 (RSV) 住院风险和严重的结果. 需要进一步的研究来重新评估这些策略.

科学领域:

免疫学
儿童医学
公共卫生

背景情况:

呼吸道同胞病毒 (RSV) 是婴儿住院的重要原因.
已推出两种新的预防策略,即母体免疫接种 (RSVpref疫苗) 和婴儿免疫接种 (nirsevimab).
目前缺乏这两种RSV预防方法的有效性比较数据.

研究的目的:

为了比较母体RSVpreF疫苗接种与婴儿nirsevimab免疫接种的有效性.
评估RSV相关的婴儿住院的预防.

主要方法:

使用法国国家健康数据系统进行基于人口的队列研究.
包括2024年9月1日至12月31日出生的婴儿.
孕产妇接种疫苗 (RSVpreF) 和婴儿免疫 (nirsevimab) 组与1:1相匹配,随访时间为2025年2月28日.

主要成果:

与RSVpreF疫苗相比,nirsevimab与RSV住院的风险显著降低 (aHR,0. 74;95% CI,0. 61- 0. 88).
婴儿被动免疫使用nirsevimab也减少了严重的结果,包括PICU入院 (aHR,0. 58) 和通风需求 (aHR,0. 57).
在各个子组和敏感性分析中,结果保持一致.

结论:

与母体RSVpreF疫苗接种相比,使用nirsevimab对婴儿的被动免疫在预防RSV相关住院和严重后果方面表现出更高的有效性.
这些发现代表了在法国使用这些策略的初始RSV季节.
建议在未来的研究中重新评估这些免疫策略.

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