AbstractThe continuous emergence of SARS-CoV-2 variants of concern has rendered many therapeutic monoclonal antibodies (mAbs) ineffective. To date, there are no clinically authorized therapeutic antibodies effective against the recently circulating Omicron sub-lineages BA.2.86 and JN.1. Here, we report the isolation of broad and potent neutralizing human mAbs (HuMabs) from a healthcare worker infected with SARS-CoV-2 early in the pandemic.

摘要SARS-CoV-2变体的不断出现使许多治疗性单克隆抗体（mAb）无效。迄今为止，尚无临床授权的治疗性抗体可有效抵抗最近循环的Omicron亚谱系BA.2.86和JN.1。在这里，我们报告了在大流行早期从感染SARS-CoV-2的医护人员中分离出广泛而有效的中和人单克隆抗体（humAb）。

These include a genetically unique HuMab, named K501SP6, which can neutralize different Omicron sub-lineages, including BQ.1, XBB.1, BA.2.86 and JN.1, by targeting a highly conserved epitope on the N terminal domain, as well as an RBD-specific HuMab (K501SP3) with high potency towards earlier circulating variants that was escaped by the more recent Omicron sub-lineages through spike F486 and E484 substitutions.

这些包括一种遗传上独特的HuMab，命名为K501SP6，它可以通过靶向N末端结构域上的高度保守的表位来中和不同的Omicron亚谱系，包括BQ.1，XBB.1，BA.2.86和JN.1，以及RBD特异性HuMab（K501SP3），其对早期循环变体具有高效力，最近的Omicron亚谱系通过尖峰F486和E484取代逃逸。

Characterizing SARS-CoV-2 spike-specific HuMabs, including broadly reactive non-RBD-specific HuMabs, can give insight into the immune mechanisms involved in neutralization and immune evasion, which can be a valuable addition to already existing SARS-CoV-2 therapies..

表征SARS-CoV-2穗特异性humAb，包括广泛反应的非RBD特异性humAb，可以深入了解中和和免疫逃避所涉及的免疫机制，这可能是对现有SARS-CoV-2疗法的有价值的补充。。

IntroductionSARS-CoV-2, the etiological agent of coronavirus disease (COVID-19), has caused one of the most challenging pandemics in recent history, resulting in an estimated >7 million deaths since it emerged in Wuhan, China at the end of 20191,2,3. Throughout the pandemic, variants of concern (VoCs) (including Alpha, Beta, Gamma, Delta and most recently Omicron) have emerged and posed new challenges such as reduced susceptibility to vaccine induced immunity, escape from therapeutic monoclonal antibodies (mAbs), and increased transmission rates4,5,6,7,8,9.

引言SARS-CoV-2是冠状病毒病（COVID-19）的病原体，已引起近代史上最具挑战性的大流行之一，自20191年底在中国武汉出现以来，估计有700多万人死亡，2,3。在整个大流行过程中，出现了令人担忧的变体（VoCs）（包括α，β，γ，δ和最近的Omicron），并提出了新的挑战，例如降低了对疫苗诱导免疫的敏感性，逃避了治疗性单克隆抗体（mAb），并增加了传播率4,5,6,7,8,9。

Many of the substitutions present in these VoCs are located in the ~22 kDa receptor binding domain (RBD) of the spike protein, which is the primary target of protective antibodies and facilitates viral entry by interacting with angiotensin converting enzyme 2 (ACE2) on host epithelial cells10,11,12.

这些挥发性有机化合物中存在的许多取代位于刺突蛋白的〜22 kDa受体结合结构域（RBD）中，这是保护性抗体的主要靶标，并通过与血管紧张素转换酶2（ACE2）相互作用促进病毒进入宿主上皮细胞10,11,12。

Compared to the Wuhan-Hu-1 strain, the Omicron BA.1 variant includes 15 substitutions in the RBD, many of which have been associated with immune evasion13,14,15,16. Furthermore, a diverse array of Omicron sub-lineages, including BA.2, BA.2.75, BA.5, BQ.1, XBB.1, BA.2.86, and JN.1, have continuously emerged.

与武汉-Hu-1株相比，Omicron BA.1变体在RBD中包含15个取代，其中许多与免疫逃避有关13,14,15,16。此外，不断出现各种各样的Omicron亚谱系，包括BA.2，BA.2.75，BA.5，BQ.1，XBB.1，BA.2.86和JN.1。

These sub-linages have additional spike substitutions which have resulted in resistance to neutralization that could lead to increased hospitalization and deaths17,18,19. Currently circulating sub-lineages include BA.2.86, which was first observed in August 2023, and gave rise to the JN.1 sub-lineage.

。目前流行的亚谱系包括BA.2.86，该谱系于2023年8月首次观察到，并产生了JN.1亚谱系。

By December 2023, JN.1 exhibited a sharp increase in frequency in Europe and the United States of America, becoming the dominant variant globally20,21,22,23.Early in the pandemic, RBD-specific mAbs were used as an effective countermeasure to avoid further disease progression in those with severe COVID-1924,25,26.

到2023年12月，约1在欧洲和美国的频率急剧增加，成为全球的主要变异20,21,22,23。在大流行早期，RBD特异性单克隆抗体被用作有效的对策，以避免严重COVID-1924,25,26患者的进一步疾病进展。

These mA.

这些妈妈。

Data availability

数据可用性

All data is available in Supplementary Data and on request. The atomic coordinates and electron microscopy data have been deposited in the RCSB Protein Data Bank and in the Electron Microscopy Data Bank under the entries: PDB: 9FJK and EMDB ID: EMD-50503 for the K501SP6 electron density map and protein model, and Omicron B.1.1.529 2 RBD up conformation (PDB: 85CR and EMDB ID: EMD-16441) for the K501SP3 electron density map.

所有数据均可在补充数据和要求中获得。原子坐标和电子显微镜数据已保存在RCSB蛋白质数据库和电子显微镜数据库中，条目为：K501SP6电子密度图和蛋白质模型的PDB:9FJK和EMDB ID:EMD-50503，以及K501SP3电子密度图的Omicron B.1.1.529 2 RBD-up构象（PDB:85CR和EMDB ID:EMD-16441）。

Sequences for K501SP1-K501SP7 are under GenBank accession numbers PQ255962 - PQ255975..

K501SP1-K501SP7的序列在GenBank登录号PQ255962-PQ255975下。。

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Download referencesAcknowledgementsWe would like the acknowledge Jeffrey Copps for the production of Covid-1R. WA.1 Spike protein. Hannah Turner and Anant Gharpure for assistance with the Glacios microscope and Sandhya Bangaru for assistance in processing. SSRR and KTW acknowledge the Core Facility for Integrated Microscopy (CFIM), University of Copenhagen for providing support in data collection.

下载参考文献致谢我们希望获得Jeffrey Copps对Covid-1R生产的认可。WA.1穗蛋白。汉娜·特纳（HannahTurner）和阿南特·加尔普尔（AnantGharpure）协助制作冰川显微镜，桑迪亚·班加鲁（SandhyaBangaru）协助加工。SSRR和KTW感谢哥本哈根大学集成显微镜核心设施（CFIM）在数据收集方面提供的支持。

This research was funded by the Novo Nordisk Foundation (NNF170C0026778), a Semper Ardens grant to A.S. from the Carlsberg Foundation (CF20-0045), and support from the Independent Research Fund Denmark (FSS) (118248). SSRR and KT are funded by the Lundbeck Foundation (R344-2020-934) and the Independent Research Fund Denmark (9039-00123B).

这项研究由诺和诺德基金会（NNF170C0026778），嘉士伯基金会（CF20-0045）向a.S.提供的Semper Ardens赠款以及丹麦独立研究基金（FSS）的支持（118248）资助。SSRR和KT由伦贝克基金会（R344-2020-934）和丹麦独立研究基金（9039-00123B）资助。

CO-HEP is funded by The Novo Nordisk Foundation Distinguished Investigator grant (NNF19OC0054518) and Tandem grant (NNF19OC0055462) awarded to JB, a BRIDGE translational excellence fellowship to AU, The Candys Foundation PhD grant (2022-395) to AB, The Capital Region of Denmark’s Research Foundation and the Mauritzen La Fontaine Fonden.

CO-HEP由诺和诺德基金会杰出研究员奖（NNF19OC0054518）和授予JB的串联奖（NNF19OC0055462）资助，JB是非盟的桥梁转化卓越奖学金，坎迪斯基金会博士奖（2022-395）授予AB，丹麦研究基金会的首都地区和毛里岑拉方丹方登。

AS if funded through Novo Nordisk Foundation, Distinguished Innovator grant NNF22OC0076055.Author informationAuthors and AffiliationsCentre for Translational Medicine and Parasitology, Department of Immunology and Microbiology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, DenmarkMelanie R.

好像是由诺和诺德基金会资助的，杰出创新者资助NNF22OC0076055。作者信息哥本哈根大学健康与医学院免疫学与微生物学系转化医学与寄生虫学作者和附属机构。

Walker, Kasper H. Björnsson, Sai Sundar Rajan Raghavan, Maria R. Bassi, Robert Dagil, Anne S. Knudsen, Ali Salanti & Lea BarfodCopenhagen Hepatitis C Program (CO-HEP), Department of Infectious Diseases, Copenhagen University Hospital, Hvidovre and Department of Immunology and Microbiology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, DenmarkAle.

Walker，Kasper H.Björnsson，Sai Sundar Rajan Raghavan，Maria R.Bassi，Robert Dagil，Anne S.Knudsen，Ali Salanti＆Lea BarfodCopenhagen丙型肝炎计划（CO-HEP），哥本哈根大学医院传染病系，Hvidovre和哥本哈根大学健康与医学科学学院免疫学和微生物学系，哥本哈根，登马卡尔。

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PubMed Google ScholarContributionsM.R.W. and L.B conceived the project. M.R.W., A.U., K.H.B., S.S.R.R., M.R.B., A.B., L.V.P., S.R., M.P., R.D., A.S.K., M.I., K.W., conducted and designed experiments. M.R.W., A.U., K.H.B., S.S.R.R., M.R.B., A.B., L.V.P., S.R., M.P., R.D., A.S.K., M.I., K.W., M.S., A.B.W., A.S., J.B., and L.B analyzed the data and provided intellectual contribution.

PubMed谷歌学术贡献。R、 W.和L.B构思了这个项目。M、 R.W.，A.U.，K.H.B.，S.S.R.R.，M.R.B.，A.B.，L.V.P.，S.R.，M.P.，R.D.，A.S.K.，M.I.，K.W.，进行并设计了实验。M、 R.W.，A.U.，K.H.B.，S.S.R.R.，M.R.B.，A.B.，L.V.P.，S.R.，M.P.，R.D.，A.S.K.，M.I.，K.W.，M.S.，A.B.W.，A.S.，J.B。和L.B分析了数据并提供了智力贡献。

M.R.W wrote the initial draft of the manuscript, which was edited and approved by all authors.Corresponding authorCorrespondence to.

M、 R.W撰写了手稿的初稿，并由所有作者编辑和批准。。

Lea Barfod.Ethics declarations

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Competing interests

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The authors declare no competing interests.

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Peer review

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同行评审信息

Communications Biology thanks George Carnell, Kelly da Costa, and the other, anonymous, reviewer for their contribution to the peer review of this work. Primary Handling Editors: Caroline Goujon and Johannes Stortz.

《传播生物学》感谢乔治·卡内尔（GeorgeCarnell）、凯利·达·科斯塔（KellyDaCosta）和另一位匿名审稿人对这项工作的同行评议做出的贡献。主要处理编辑：卡罗琳·古洪（CarolineGoujon）和约翰内斯·斯托茨（JohannesStortz）。

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Reprints and permissionsAbout this articleCite this articleWalker, M.R., Underwood, A., Björnsson, K.H. et al. Broadly potent spike-specific human monoclonal antibodies inhibit SARS-CoV-2 Omicron sub-lineages.

转载和许可本文引用本文Walker，M.R.，Underwood，A.，Björnsson，K.H。等人。广泛有效的穗特异性人单克隆抗体抑制SARS-CoV-2 Omicron亚谱系。

Commun Biol 7, 1239 (2024). https://doi.org/10.1038/s42003-024-06951-7Download citationReceived: 31 October 2023Accepted: 24 September 2024Published: 02 October 2024DOI: https://doi.org/10.1038/s42003-024-06951-7Share this articleAnyone you share the following link with will be able to read this content:Get shareable linkSorry, a shareable link is not currently available for this article.Copy to clipboard.

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