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尼塞韦单抗、呼吸道合胞病毒(RSV)母体疫苗和老年人RSV疫苗在现实世界中的应用:一项系统评价和荟萃分析。

Real-world uptake of nirsevimab, RSV maternal vaccine, and RSV vaccines for older adults: a systematic review and meta-analysis.

作者信息

Trusinska Daira, Lee Bohee, Ferdous Sohail, Kwok Harley H Y, Gordon Becky, Gao Junyi, Ma Liantao, Xiong Hanbiao, Sheikh Sir Aziz, Schwarze Jürgen, Busby John, Gibbons Cheryl, Drysdale Simon B, Ritchie Sir Lewis, Williams Thomas, Shi Ting

机构信息

Usher Institute, Edinburgh Medical School, University of Edinburgh, Edinburgh, UK.

National Heart & Lung Institute, Imperial College London, London, UK.

出版信息

EClinicalMedicine. 2025 Jun 3;84:103281. doi: 10.1016/j.eclinm.2025.103281. eCollection 2025 Jun.

Abstract

BACKGROUND

In clinical trials, recently introduced respiratory syncytial virus (RSV) immunisation products have shown high efficacy in preventing severe RSV outcomes. Implementing successful immunisation programmes is however key to realising these benefits in real-world settings. We aimed to investigate uptake of the long-acting monoclonal antibody nirsevimab, the RSV maternal vaccine, and RSV vaccines for older adults in countries where immunisation programmes have been introduced, and to explore how uptake varies between countries and population subgroups.

METHODS

In this systematic review and meta-analysis, we carried out four monthly searches in Medline, Embase, and Global Health databases for studies reporting uptake of nirsevimab, the RSV maternal vaccine, and RSV vaccines for older adults. We included population-based studies published between December 1, 2022 and February 5, 2025. Two independent reviewers screened studies, extracted data, and completed a risk of bias assessment using the Joanna Briggs Institute (JBI) Critical Appraisal Tools. We assessed uptake stratified by country and socio-demographic and clinical subgroups. Meta-analyses were conducted using random-effects modelling. PROSPERO registration number: CRD42025643585.

FINDINGS

We screened a total of 1267 studies, 43 of which met the inclusion criteria reporting data on over 1.38 million individuals from six countries. Nirsevimab uptake data were reported in 34 studies: 16 from Spain, eight from the United States, seven from France, one with combined data from Andorra and Spain, and one from each of Italy and Luxembourg. Our pooled estimates showed that nirsevimab uptake on population level was 90.1% (95% confidence interval (CI): 86.4-92.9) in Spain and 51.2% (95% CI: 29.3-72.7) in the United States during the 2023/24 RSV season. Uptake data for the RSV maternal vaccine and RSV vaccines for older adults were reported in five and eight studies, respectively, all from the United States. Meta-analysis showed population-level uptake of 30.5% (95% CI: 20.6-42.6) and 18.2% (95% CI: 10.8-28.9), respectively. Uptake varied across subgroups.

INTERPRETATION

Uptake of nirsevimab varied substantially between the countries that have implemented infant RSV immunisation programmes. Despite the limited number of studies and the lack of more accurate data at national level the low uptake estimates for RSV maternal vaccine and RSV vaccines for older adults are concerning. National, clinical, and public health initiatives are needed to increase uptake of RSV immunisation products and ensure maximum benefit to people currently at risk of severe RSV outcomes.

FUNDING

Health Data Research UK, Inflammation and Immunity Driver Programme.

摘要

背景

在临床试验中,近期推出的呼吸道合胞病毒(RSV)免疫产品在预防严重RSV感染后果方面显示出高效性。然而,实施成功的免疫计划是在现实环境中实现这些益处的关键。我们旨在调查在已引入免疫计划的国家中,长效单克隆抗体尼塞韦单抗、RSV母体疫苗以及老年人RSV疫苗的接种情况,并探讨接种情况在不同国家和人群亚组之间的差异。

方法

在这项系统评价和荟萃分析中,我们每月在Medline、Embase和全球卫生数据库中进行四次检索,以查找报告尼塞韦单抗、RSV母体疫苗以及老年人RSV疫苗接种情况的研究。我们纳入了2022年12月1日至2025年2月5日期间发表的基于人群的研究。两名独立的审阅者筛选研究、提取数据,并使用乔安娜·布里格斯研究所(JBI)的批判性评价工具完成偏倚风险评估。我们评估了按国家以及社会人口学和临床亚组分层的接种情况。使用随机效应模型进行荟萃分析。国际前瞻性系统评价注册编号:CRD42025643585。

结果

我们总共筛选了1267项研究,其中43项符合纳入标准,报告了来自六个国家的超过138万人的数据。34项研究报告了尼塞韦单抗的接种数据:16项来自西班牙,8项来自美国,7项来自法国,1项合并了安道尔和西班牙的数据,1项来自意大利和卢森堡各1项。我们的汇总估计显示,在2023/24 RSV季节,西班牙人群层面的尼塞韦单抗接种率为90.1%(95%置信区间(CI):   86.4 - 92.9),美国为51.2%(95% CI:29.3 - 72.7)。分别有5项和8项研究报告了RSV母体疫苗和老年人RSV疫苗的接种数据,均来自美国。荟萃分析显示人群层面的接种率分别为30.5%(95% CI:20.6 - 42.6)和18.2%(95% CI:10.8 - 28.9)。接种情况在亚组之间存在差异。

解读

在已实施婴儿RSV免疫计划的国家中,尼塞韦单抗的接种情况差异很大。尽管研究数量有限且缺乏国家层面更准确的数据,但RSV母体疫苗和老年人RSV疫苗的低接种估计令人担忧。需要国家、临床和公共卫生举措来提高RSV免疫产品的接种率,并确保目前有严重RSV感染后果风险的人群获得最大益处。

资助

英国卫生数据研究,炎症与免疫驱动计划。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3f01/12167775/2778bbcf9e4f/gr1.jpg

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