Williams Thomas C, Marlow Robin, Cunningham Steve, Drysdale Simon B, Groves Helen E, Hunt Samantha, Iskander Dalia, Liu Xinxue, Lyttle Mark D, Mpamhanga Chengetai D, O'Hagan Shaun, Waterfield Thomas, Roland Damian
Child Life and Health, University of Edinburgh, Edinburgh, UK; Department of Paediatric Respiratory and Sleep Medicine, Royal Hospital for Children and Young People, Edinburgh, UK.
Emergency Department, Bristol Royal Hospital for Children, Bristol, UK; NIHR Health Protection Research Unit in Behavioural Science and Evaluation, University of Bristol, Bristol, UK.
Lancet Child Adolesc Health. 2025 Jul 18. doi: 10.1016/S2352-4642(25)00155-5.
Respiratory syncytial virus (RSV) is the leading cause of acute lower respiratory infections (ALRI) in infants younger than 6 months globally. A maternal bivalent RSV prefusion F (RSVpreF) vaccine was introduced to the UK in late summer in 2024 (August 12 in Scotland and September 1 in England), with all pregnant women at 28 weeks or more of gestation eligible for vaccination. We aimed to understand RSVpreF vaccine effectiveness in a real-world setting.
We conducted a multicentre, test-negative, case-control study to analyse the vaccine effectiveness of maternal RSVpreF vaccination against the primary outcome of hospitalisation (ie, admission to hospital) for RSV-associated ALRI in infants. Patient and public involvement from a group of parents informed the study protocol design. Included patients were infants with ALRI born after Aug 12, 2024 (Scotland), and Sept 1, 2024 (England), and therefore had mothers eligible for maternal vaccination, who were admitted to 30 hospital sites across the UK from Sept 30, 2024, to Jan 20, 2025, and tested for RSV. Infants were followed up until hospital discharge or death as an inpatient. Primary vaccine effectiveness of maternal RSVpreF vaccination against RSV-associated hospitalisation was calculated with the use of a conditional logistic regression adjusted by site, calendar month of hospital attendance for the infant, age, preterm birth, and sex.
We included 537 mother-infant pairs, in whom there were 391 RSV-positive infant cases (median age 1·63 months [IQR 0·94-2·26]) and 146 RSV-negative infant controls (1·41 months [0·77-2·03]). Of 537 recruited infants, 297 (55%) were male and 240 (45%) were female. Ethnicity data were available for 533 mothers, of whom 434 (81%) self-identified as White. The mothers of 73 (19%) RSV-positive cases and 60 (41%) RSV-negative controls had received RSVpreF vaccine before delivery. The adjusted effectiveness of maternal RSVpreF vaccination for preventing infant hospitalisation was 58% (95% CI 28-75) for infants whose mothers were vaccinated at any time before delivery and 72% (48-85) for infants whose mothers were vaccinated more than 14 days before delivery (39 [11%] of 357 RSV-positive cases vs 43 [33%] of 129 RSV-negative controls).
In the real-world setting of the first season of vaccine implementation in England and Scotland, maternal RSVpreF vaccination was effective and equivalent to trial settings in reducing the risk of hospitalisation in infants with RSV-associated ALRI.
National Institute for Health and Care Research, The Wellcome Trust, and Imperial College London.
呼吸道合胞病毒（RSV）是全球6个月以下婴儿急性下呼吸道感染（ALRI）的主要病因。一种母体二价RSV预融合F（RSVpreF）疫苗于2024年夏末引入英国（苏格兰于8月12日，英格兰于9月1日），所有妊娠28周及以上的孕妇有资格接种疫苗。我们旨在了解RSVpreF疫苗在现实环境中的有效性。
我们进行了一项多中心、检测阴性的病例对照研究，以分析母体RSVpreF疫苗接种对婴儿RSV相关ALRI住院（即入院）这一主要结局的疫苗有效性。一组家长的患者和公众参与为研究方案设计提供了信息。纳入的患者为2024年8月12日（苏格兰）和2024年9月1日（英格兰）之后出生的患有ALRI的婴儿，因此其母亲有资格进行母体疫苗接种，这些婴儿于2024年9月30日至2025年1月20日被收治到英国30个医院站点并接受RSV检测。婴儿随访至出院或作为住院患者死亡。母体RSVpreF疫苗接种预防RSV相关住院的主要疫苗有效性通过使用条件逻辑回归进行计算，并根据站点、婴儿住院的日历月份、年龄、早产和性别进行调整。
我们纳入了537对母婴，其中有391例RSV阳性婴儿病例（中位年龄1.63个月[四分位间距0.94 - 2.26]）和146例RSV阴性婴儿对照（1.41个月[0.77 - 2.03]）。在537名招募的婴儿中，297名（55%）为男性，240名（45%）为女性。533名母亲的种族数据可用，其中434名（81%）自我认定为白人。73例（19%）RSV阳性病例和60例（41%）RSV阴性对照的母亲在分娩前接受了RSVpreF疫苗接种。对于母亲在分娩前任何时间接种疫苗的婴儿，母体RSVpreF疫苗接种预防婴儿住院的调整后有效性为58%（95%置信区间28 - 75），对于母亲在分娩前14天以上接种疫苗的婴儿，有效性为％（48 - 85）（357例RSV阳性病例中的39例[11%]对比129例RSV阴性对照中的43例[33%]）。
在英格兰和苏格兰疫苗实施的第一个季节的现实环境中，母体RSVpreF疫苗接种有效，在降低RSV相关ALRI婴儿住院风险方面与试验环境相当。
国家卫生与保健研究机构、惠康信托基金会和伦敦帝国学院。
