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呼吸道合胞病毒疫苗和单克隆抗体领域:通向全球可及之路。

The respiratory syncytial virus vaccine and monoclonal antibody landscape: the road to global access.

机构信息

Department of Paediatric Infectious Disease & Immunology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, Netherlands.

Yenepoya Medical College & Centre for Ethics, Yenepoya University, Mangalore, India.

出版信息

Lancet Infect Dis. 2024 Dec;24(12):e747-e761. doi: 10.1016/S1473-3099(24)00455-9. Epub 2024 Sep 23.

Abstract

Respiratory syncytial virus (RSV) is the second most common pathogen causing infant mortality. Additionally, RSV is a major cause of morbidity and mortality in older adults (age ≥60 years) similar to influenza. A protein-based maternal vaccine and monoclonal antibody (mAb) are now market-approved to protect infants, while an mRNA and two protein-based vaccines are approved for older adults. First-year experience protecting infants with nirsevimab in high-income countries shows a major public health benefit. It is expected that the RSV vaccine landscape will continue to develop in the coming years to protect all people globally. The vaccine and mAb landscape remain active with 30 candidates in clinical development using four approaches: protein-based, live-attenuated and chimeric vector, mRNA, and mAbs. Candidates in late-phase trials aim to protect young infants using mAbs, older infants and toddlers with live-attenuated vaccines, and children and adults using protein-based and mRNA vaccines. This Review provides an overview of RSV vaccines highlighting different target populations, antigens, and trial results. As RSV vaccines have not yet reached low-income and middle-income countries, we outline urgent next steps to minimise the vaccine delay.

摘要

呼吸道合胞病毒(RSV)是导致婴儿死亡的第二大常见病原体。此外,RSV 也是导致老年人(年龄≥60 岁)发病率和死亡率的主要原因,其类似于流感。目前已有基于蛋白质的母体疫苗和单克隆抗体(mAb)获批用于保护婴儿,而一种 mRNA 和两种基于蛋白质的疫苗则获批用于老年人。在高收入国家,使用 nirsevimab 保护婴儿的第一年经验表明其具有重大的公共卫生效益。预计在未来几年,RSV 疫苗的研发将继续推进,以保护全球所有人。疫苗和 mAb 的研发仍然活跃,有 30 种候选疫苗正在使用四种方法进行临床开发:基于蛋白质、减毒活疫苗和嵌合载体、mRNA 和 mAb。处于后期试验阶段的候选疫苗旨在使用 mAb 保护婴幼儿,使用减毒活疫苗保护婴儿和幼儿,以及使用基于蛋白质和 mRNA 的疫苗保护儿童和成人。本综述概述了 RSV 疫苗,重点介绍了不同的目标人群、抗原和试验结果。由于 RSV 疫苗尚未到达低收入和中等收入国家,我们概述了急需采取的下一步措施,以尽量减少疫苗延迟。

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