Virology Research Laboratory, Serology and Virology Division (SAViD), NSW Health Pathology, Prince of Wales Hospital, Sydney, Australia.
Department of Immunology and Infectious Diseases, Sydney Children's Hospital Network, Sydney, Australia.
Rev Med Virol. 2024 Sep;34(5):e2576. doi: 10.1002/rmv.2576.
Respiratory syncytial virus (RSV) is a leading cause of acute respiratory infection amongst all ages, causing a significant global health burden. Preventative and therapeutic options for RSV infection have long been under development, and recently, several widely-publicised vaccines targeting older adult and maternal populations have become available. Promising monoclonal antibody (mAb) and antiviral (AV) therapies are also progressing in clinical trials, with the prophylactic mAb nirsevimab recently approved for clinical use in infant populations. A systematic review on current progress in this area is lacking. We performed a systematic literature search (PubMed, Embase, Web of Science, ClinicalTrials.gov, EudraCT, ANZCTR-searched Nov 29th, 2023) to identify studies on all RSV-specific mAbs and AV therapies that has undergone human clinical trials since year 2000. Data extraction focused on outcomes related to the therapeutic efficacy and safety of the intervention on trial, and all studies were graded against the OCEBM Levels of Evidence Table. Results from 59 studies were extracted, covering efficacy and safety data on six mAbs (motavizumab, motavizumab-YTE, nirsevimab, ALX-0171, suptavumab, clesrovimab) and 12 AV therapies (ALN-RSV01, RSV604, presatovir, MDT-637, lumicitabine, IFN-α1b, rilematovir, enzaplatovir, AK0529, sisunatovir, PC786, EDP-938). Of the mAbs reviewed, nirsevimab and clesrovimab hold considerable promise. The timeline for RSV-specific AV availability is less advanced, although EDP-938 and AK0529 have reported promising phase 2 efficacy and safety data. Moving forward, passive immunisation and treatment options for RSV infection will play a significant role in reducing the health burden of RSV, complementing recent advancements in vaccine development. TRIAL REGISTRATION: PROSPERO registration: CRD42022376633.
呼吸道合胞病毒（RSV）是所有年龄段急性呼吸道感染的主要原因，对全球健康造成了重大负担。针对 RSV 感染的预防和治疗选择长期以来一直在开发中，最近，几种针对老年和孕产妇人群的广为人知的疫苗已经问世。有前途的单克隆抗体（mAb）和抗病毒（AV）疗法也在临床试验中取得进展，最近预防用 mAb nirsevimab 已获得临床应用于婴儿人群的批准。目前在这一领域缺乏系统的综述。我们进行了系统的文献检索（PubMed、Embase、Web of Science、ClinicalTrials.gov、EudraCT、ANZCTR-搜索 2023 年 11 月 29 日），以确定自 2000 年以来所有针对 RSV 特异性 mAb 和 AV 疗法的已进行人体临床试验的研究。数据提取侧重于试验中干预的治疗效果和安全性相关的结果，所有研究均根据 OCEBM 证据水平表进行分级。从 59 项研究中提取了结果，涵盖了六款 mAb（motavizumab、motavizumab-YTE、nirsevimab、ALX-0171、suptavumab、clesrovimab）和 12 种 AV 疗法（ALN-RSV01、RSV604、presatovir、MDT-637、lumicitabine、IFN-α1b、rilematovir、enzaplatovir、AK0529、sisunatovir、PC786、EDP-938）的疗效和安全性数据。在审查的 mAb 中，nirsevimab 和 clesrovimab 具有很大的潜力。针对 RSV 的 AV 可用性的时间表进展较慢，尽管 EDP-938 和 AK0529 报告了有前途的 2 期疗效和安全性数据。展望未来，针对 RSV 感染的被动免疫和治疗选择将在减轻 RSV 对健康的负担方面发挥重要作用，补充最近在疫苗开发方面的进展。试验注册：PROSPERO 注册：CRD42022376633。
