近日，法国巴黎萨克雷大学Mahmoud Zureik团队比较了尼塞韦单抗与RSVpreF疫苗在新生儿呼吸道合胞病毒相关住院治疗中的预防效果。2025年12月22日，《美国医学会杂志》发表了这一成果。

呼吸道合胞病毒（RSV）是婴儿住院的主要原因。最近引入的两种预防策略（母亲接种RSV预融合F蛋白[RSVpreF]疫苗后通过胎盘抗体转移进行婴儿免疫和婴儿被动接种尼塞韦单抗）的比较效果尚不清楚。

为了比较母亲接种RSVpreF疫苗与婴儿被动接种尼塞韦单抗预防RSV住院的相关性，研究组进行了一项基于人群的队列研究，使用来自法国国家健康数据系统的数据。2024年9月1日至12月31日在法国大陆出生的婴儿在妊娠32至36周期间接种了RSVpreF疫苗。婴儿在出院前被动接种尼塞韦单抗。婴儿按产科病房出院日期、性别、胎龄和地区按1:1匹配。随访于RSV住院或死亡时或2025年2月28日结束。

干预措施为母亲接种RSVpreF疫苗和婴儿被动接种尼塞韦单抗。主要终点是RSV相关下呼吸道感染的住院治疗。次要结局包括进入儿童重症监护病房（PICU），进入高依赖病房，呼吸机支持和氧气治疗。风险比（hr）采用处理加权逆概率的条件Cox比例风险模型估计。

共42560名婴儿（平均年龄3.7 [SD， 1.4]天，51.7%为男性）被纳入研究(21每组280例)，中位随访84天（IQR， 70-99天）。在因RSV相关下呼吸道感染住院的481例患者中，尼塞韦单抗组212例（44.1%），RSVpreF疫苗组269例（55.9%）（组间差异为11.8%）。与RSVpreF疫苗相比，婴儿被动免疫尼塞韦单抗与RSV相关下呼吸道感染住院的风险较低相关（校正HR， 0.74）。与RSVpreF疫苗相比，婴儿被动免疫尼塞韦单抗与严重结局的风险较低相关，包括PICU入院（调整HR， 0.58）、需要呼吸机支持（调整HR， 0.57）或需要氧疗（调整HR， 0.56）。结果在亚组和敏感性分析中是一致的。

研究结果表明，与母亲接种RSVpreF疫苗相比，婴儿被动接种尼塞韦单抗与RSV相关住院和严重结局的风险较低相关。这些发现反映了在法国大陆使用这些免疫策略的第一个RSV季；在未来的研究中应重新评估它们的使用。

附：英文原文

Title: Nirsevimab vs RSVpreF Vaccine for Respiratory Syncytial Virus–Related Hospitalization in Newborns

Author: Marie-Joelle Jabagi, Marion Bertrand, Amélie Gabet, Epiphane Kolla, Valérie Olié, Mahmoud Zureik

Issue&Volume: 2025-12-22

Abstract:

Importance  Respiratory syncytial virus (RSV) is a leading cause of hospitalization in infants. The comparative effectiveness of 2 recently introduced preventive strategies (infant immunization through placental antibody transfer after maternal vaccination with the RSV prefusion F protein [RSVpreF] vaccine and passive infant immunization with nirsevimab) remains unknown.

Objective  To compare the associations of maternal vaccination with the RSVpreF vaccine vs passive infant immunization with nirsevimab for the prevention of RSV-related hospitalization.

Design, Setting, and Participants  This population-based cohort study used data from the French National Health Data System. Maternal vaccination with the RSVpreF vaccine occurred during 32 to 36 weeks’ gestation among infants born in mainland France between September 1 and December 31, 2024. Passive infant immunization with nirsevimab occurred prior to hospital discharge. Infants were matched 1:1 by maternity ward discharge date, sex, gestational age, and region. Follow-up ended at the time of RSV hospitalization or death or on February 28, 2025.

Exposures  Maternal immunization with the RSVpreF vaccine and passive infant immunization with nirsevimab.

Main Outcomes and Measures  The primary outcome was hospitalization for RSV-associated lower respiratory tract infection. The secondary outcomes included admission to the pediatric intensive care unit (PICU), admission to high-dependency unit, ventilator support, and oxygen therapy. The hazard ratios (HRs) were estimated using conditional Cox proportional hazards models with inverse probability of treatment weighting.

Results  A total of 42560 infants (mean age, 3.7 [SD, 1.4] days; 51.7% male) were included in the study (21280 per group) with a median follow-up of 84 days (IQR, 70-99 days). Of the 481 hospitalizations for RSV-associated lower respiratory tract infection, 212 (44.1%) occurred in the nirsevimab group vs 269 (55.9%) in the RSVpreF vaccine group (between-group difference, 11.8% [95% CI, 18.1% to 5.5%]). Compared with the RSVpreF vaccine, passive infant immunization with nirsevimab was associated with a lower risk of hospitalization for RSV-associated lower respiratory tract infection (adjusted HR, 0.74 [95% CI, 0.61 to 0.88]). Compared with the RSVpreF vaccine, passive infant immunization with nirsevimab was associated with a lower risk of severe outcomes, including PICU admission (adjusted HR, 0.58 [95% CI, 0.42 to 0.80]), requiring ventilator support (adjusted HR, 0.57 [95% CI, 0.40 to 0.81]), or requiring oxygen therapy (adjusted HR, 0.56 [95% CI, 0.38 to 0.81]). The results were consistent across subgroups and in the sensitivity analyses.

Conclusions and Relevance  Compared with maternal vaccination with the RSVpreF vaccine, passive infant immunization with nirsevimab was associated with lower risks of RSV-related hospitalization and severe outcomes. These findings reflect the first RSV season with use of these immunization strategies in mainland France; their use should be reevaluated in future studies.

DOI: 10.1001/jama.2025.24082

Source: https://jamanetwork.com/journals/jama/fullarticle/2843212