《生命科学》 2026, 38(9): 1594-1606
RSV预防策略：疫苗和单克隆抗体
摘 要：
呼吸道合胞病毒（respiratory syncytial virus，RSV）是引发婴幼儿、老年人及免疫功能低下人群下呼吸道感染的主要病原体之一，给全球公共卫生体系带来沉重的疾病负担与社会经济压力。近年来，随着对RSV抗原表位认知的不断深入，三款基于结构理性设计的疫苗（Arexvy、Abrysvo和mRESVIA）以及两种长效单克隆抗体（Nirsevimab和Clesrovimab）已相继成功研发并投入应用。与此同时，RSV防控产品的研发管线持续扩容，更多基于传统与创新技术路径的疫苗及单克隆抗体正处于积极的临床研发进程中。候选产品涵盖重组亚单位疫苗、mRNA疫苗、减毒活疫苗、载体疫苗、组合疫苗、长效单克隆抗体等，旨在进一步突破现有产品的应用局限。本文系统综述了目前已获批上市及处于临床开发阶段的RSV疫苗与长效单克隆抗体，并介绍其在不同人群中的临床试验结果，分析现有产品的优势与局限，同时展望未来RSV预防药物的研发方向。
通讯作者：严景华 , Email:yanjinghua@cpl.ac.cn
Abstract:
RSV is one of the leading pathogens globally causing lower respiratory tract infections in infants, young children, older adults, and immunocompromised individuals, imposing a significant disease burden and socioeconomic pressure on public health systems orldwide. In recent years, with the rapid advancements in structural biology, immunology, and protein engineering, researchers have deepened their understanding of RSV antigenic epitopes. Notably, the elucidation of the structure and function of key neutralizing epitopes on the viral fusion (F) protein has paved the way for the rational, structure-based design of preventive products. Against this backdrop, three structure-based, rationally designed vaccines targeting the RSV prefusion F (pre F) protein have been successfully developed and deployed. These include the recombinant subunit vaccine Arexvy and mRNA vaccine mRESVIA for older and high-risk adults, and the bivalent recombinant vaccine Abrysvo, which is indicated for pregnant individuals (providing passive protection to infants through maternal antibodies), older and high-risk adults. Concurrently, two long-acting monoclonal antibodies for infants, Nirsevimab and Clesrovimab, have been approved, establishing a diversified RSV prevention barrier for different populations. Meanwhile, the pipeline for RSV prevention products continues to expand, with numerous vaccines and monoclonal antibodies based on both traditional and innovative technological platforms advancing through active clinical development. This pipeline encompasses recombinant subunit vaccines, mRNA vaccines, live attenuated vaccines, vector vaccines, combination vaccines, and long-acting monoclonal antibodies. These candidate products aim to further overcome the limitations of existing options by enhancing immunogenicity in immunocompromised populations, extending the duration of protection, and optimizing routes of administration. This article presents a systematic review of currently approved and clinically developing RSV vaccines and long-acting monoclonal antibodies. It summarizes the design principles, immunogenicity profiles, and key research progress for each product category. Additionally, it presents clinical trial results across various populations, such as infants, and older adults, analyzes the strengths and limitations of existing products, and offers perspectives on future directions in RSV prophylactic drug development.
Communication Author：YAN Jing-Hua , Email:yanjinghua@cpl.ac.cn
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