ABSTRACT

Introduction

Respiratory Syncytial Virus (RSV) is a leading cause of acute lower respiratory infections worldwide. The RSV fusion (F) glycoprotein is a major focus of vaccine development. Despite over 60 years of research, there is no licensed vaccine for RSV.

Areas covered

The primary focus of this review is a novel RSV-F recombinant nanoparticle vaccine from Novavax utilizing the F protein, a conserved and immunodominant surface glycoprotein. This RSV F recombinant nanoparticle vaccine adsorbed to 0.4 mg of aluminum phosphate was ultimately administered by a single intramuscular injection during the third trimester of pregnancy in an effort to induce passive immunity in newborns. Its mechanism, performance in clinical trials, and place in RSV vaccine history are discussed.

Expert opinion

The vaccine was safe and well tolerated in pregnant women and the results suggest potential benefits with respect to other medically relevant end-point events involving RSV-associated respiratory and all-cause disease in infants. However, the RSV-F recombinant nanoparticle vaccine did not meet the pre-specified primary success criteria for efficacy against RSV-associated, medically significant lower respiratory tract infection in infants up to 90 days of life. The potential benefits to infants from maternal immunization and excellent safety profile warrant further confirmatory studies.

中文翻译：

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呼吸道合胞病毒融合蛋白纳米颗粒疫苗概况

摘要

介绍

呼吸道合胞病毒 (RSV) 是全球急性下呼吸道感染的主要原因。RSV融合(F)糖蛋白是疫苗开发的主要焦点。尽管进行了 60 多年的研究，但没有获得许可的 RSV 疫苗。

涵盖的领域

这篇综述的主要焦点是 Novavax 的一种新型 RSV-F 重组纳米颗粒疫苗，它利用了 F 蛋白，一种保守的免疫显性表面糖蛋白。这种吸附在 0.4 mg 磷酸铝上的 RSV F 重组纳米颗粒疫苗最终在妊娠晚期通过单次肌肉注射给药，以诱导新生儿的被动免疫。讨论了它的机制、临床试验表现以及在 RSV 疫苗历史中的地位。

专家意见

该疫苗在孕妇中是安全且耐受性良好的，结果表明，在涉及婴儿 RSV 相关呼吸系统疾病和全因疾病的其他医学相关终点事件方面具有潜在益处。然而，RSV-F 重组纳米颗粒疫苗不符合预先指定的主要成功标准，即在长达 90 天的婴儿中对 RSV 相关、医学上显着的下呼吸道感染的疗效。母体免疫对婴儿的潜在益处和出色的安全性值得进一步验证研究。