IDEAS home Printed from https://ideas.repec.org/a/nat/natcom/v13y2022i1d10.1038_s41467-022-29909-x.html
   My bibliography  Save this article

Safety and serum distribution of anti-SARS-CoV-2 monoclonal antibody MAD0004J08 after intramuscular injection

Author

Listed:
  • Simone Lanini

    (Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani – IRCCS)

  • Stefano Milleri

    (University and Hospital Trust of Verona)

  • Emanuele Andreano

    (Fondazione Toscana Life Sciences)

  • Sarah Nosari

    (AchilleS Vaccine)

  • Ida Paciello

    (Fondazione Toscana Life Sciences)

  • Giulia Piccini

    (VisMederi S.r.l)

  • Alessandra Gentili

    (CROss Research)

  • Adhuna Phogat

    (Fondazione Toscana Life Sciences)

  • Inesa Hyseni

    (VisMederi S.r.l
    VisMederi Research S.r.l)

  • Margherita Leonardi

    (VisMederi S.r.l
    VisMederi Research S.r.l)

  • Alessandro Torelli

    (VisMederi S.r.l)

  • Emanuele Montomoli

    (VisMederi S.r.l
    VisMederi Research S.r.l
    University of Siena)

  • Andrea Paolini

    (Fondazione Toscana Life Sciences
    Toscana Life Sciences Sviluppo)

  • Andrea Frosini

    (Fondazione Toscana Life Sciences)

  • Andrea Antinori

    (Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani – IRCCS)

  • Emanuele Nicastri

    (Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani – IRCCS)

  • Enrico Girardi

    (Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani – IRCCS)

  • Maria Maddalena Plazzi

    (Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani – IRCCS)

  • Giuseppe Ippolito

    (Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani – IRCCS)

  • Francesco Vaia

    (Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani – IRCCS)

  • Giovanni Della Cioppa

    (Clinical R&D Consultants)

  • Rino Rappuoli

    (Fondazione Toscana Life Sciences
    University of Siena)

Abstract

The emerging threat represented by SARS-CoV-2 variants, demands the development of therapies for better clinical management of COVID-19. MAD0004J08 is a potent Fc-engineered monoclonal antibody (mAb) able to neutralize in vitro all current SARS-CoV-2 variants of concern (VoCs) including the omicron variant even if with significantly reduced potency. Here we evaluated data obtained from the first 30 days of a phase 1 clinical study (EudraCT N.: 2020-005469-15 and ClinicalTrials.gov Identifier: NCT04932850). The primary endpoint evaluated the percentage of severe adverse events. Secondary endpoints evaluated pharmacokinetic and serum neutralization titers. A single dose administration of MAD0004J08 via intramuscular (i.m.) route is safe and well tolerated, resulting in rapid serum distribution and sera neutralizing titers higher than COVID-19 convalescent and vaccinated subjects. A single dose administration of MAD0004J08 is also sufficient to effectively neutralize major SARS-CoV-2 variants of concern (alpha, beta, gamma and delta). MAD0004J08 can be a major advancement in the prophylaxis and clinical management of COVID-19.

Suggested Citation

  • Simone Lanini & Stefano Milleri & Emanuele Andreano & Sarah Nosari & Ida Paciello & Giulia Piccini & Alessandra Gentili & Adhuna Phogat & Inesa Hyseni & Margherita Leonardi & Alessandro Torelli & Eman, 2022. "Safety and serum distribution of anti-SARS-CoV-2 monoclonal antibody MAD0004J08 after intramuscular injection," Nature Communications, Nature, vol. 13(1), pages 1-8, December.
    • Handle: RePEc:nat:natcom:v:13:y:2022:i:1:d:10.1038_s41467-022-29909-x
    DOI: 10.1038/s41467-022-29909-x
    as

    Download full text from publisher

    File URL: https://www.nature.com/articles/s41467-022-29909-x
    File Function: Abstract
    Download Restriction: no
    File URL: https://libkey.io/10.1038/s41467-022-29909-x?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    References listed on IDEAS

    as
    1. Emanuele Andreano & Ida Paciello & Giulia Piccini & Noemi Manganaro & Piero Pileri & Inesa Hyseni & Margherita Leonardi & Elisa Pantano & Valentina Abbiento & Linda Benincasa & Ginevra Giglioli & Conc, 2021. "Hybrid immunity improves B cells and antibodies against SARS-CoV-2 variants," Nature, Nature, vol. 600(7889), pages 530-535, December.
    2. Sho Iketani & Lihong Liu & Yicheng Guo & Liyuan Liu & Jasper F.-W. Chan & Yiming Huang & Maple Wang & Yang Luo & Jian Yu & Hin Chu & Kenn K.-H. Chik & Terrence T.-T. Yuen & Michael T. Yin & Magdalena , 2022. "Antibody evasion properties of SARS-CoV-2 Omicron sublineages," Nature, Nature, vol. 604(7906), pages 553-556, April.
    3. Stefania Dispinseri & Massimiliano Secchi & Maria Franca Pirillo & Monica Tolazzi & Martina Borghi & Cristina Brigatti & Maria Laura Angelis & Marco Baratella & Elena Bazzigaluppi & Giulietta Venturi , 2021. "Neutralizing antibody responses to SARS-CoV-2 in symptomatic COVID-19 is persistent and critical for survival," Nature Communications, Nature, vol. 12(1), pages 1-12, December.
    Full references (including those not matched with items on IDEAS)

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    1. Dennis Lapuente & Jana Fuchs & Jonas Willar & Ana Vieira Antão & Valentina Eberlein & Nadja Uhlig & Leila Issmail & Anna Schmidt & Friederike Oltmanns & Antonia Sophia Peter & Sandra Mueller-Schmucker, 2021. "Protective mucosal immunity against SARS-CoV-2 after heterologous systemic prime-mucosal boost immunization," Nature Communications, Nature, vol. 12(1), pages 1-14, December.
    2. Tiago Gräf & Alexander A. Martinez & Gonzalo Bello & Simon Dellicour & Philippe Lemey & Vittoria Colizza & Mattia Mazzoli & Chiara Poletto & Vanessa Leiko Oikawa Cardoso & Alexandre Freitas Silva & Fe, 2024. "Dispersion patterns of SARS-CoV-2 variants Gamma, Lambda and Mu in Latin America and the Caribbean," Nature Communications, Nature, vol. 15(1), pages 1-11, December.
    3. Wenkai Han & Ningning Chen & Xinzhou Xu & Adil Sahil & Juexiao Zhou & Zhongxiao Li & Huawen Zhong & Elva Gao & Ruochi Zhang & Yu Wang & Shiwei Sun & Peter Pak-Hang Cheung & Xin Gao, 2023. "Predicting the antigenic evolution of SARS-COV-2 with deep learning," Nature Communications, Nature, vol. 14(1), pages 1-14, December.
    4. Emanuele Andreano & Ida Paciello & Silvia Marchese & Lorena Donnici & Giulio Pierleoni & Giulia Piccini & Noemi Manganaro & Elisa Pantano & Valentina Abbiento & Piero Pileri & Linda Benincasa & Ginevr, 2022. "Anatomy of Omicron BA.1 and BA.2 neutralizing antibodies in COVID-19 mRNA vaccinees," Nature Communications, Nature, vol. 13(1), pages 1-8, December.
    5. Haofeng Wang & Qi Yang & Xiaoce Liu & Zili Xu & Maolin Shao & Dongxu Li & Yinkai Duan & Jielin Tang & Xianqiang Yu & Yumin Zhang & Aihua Hao & Yajie Wang & Jie Chen & Chenghao Zhu & Luke Guddat & Hong, 2023. "Structure-based discovery of dual pathway inhibitors for SARS-CoV-2 entry," Nature Communications, Nature, vol. 14(1), pages 1-14, December.
    6. Grace Kenny & Sophie O’Reilly & Neil Wrigley Kelly & Riya Negi & Colette Gaillard & Dana Alalwan & Gurvin Saini & Tamara Alrawahneh & Nathan Francois & Matthew Angeliadis & Alejandro Abner Garcia Leon, 2023. "Distinct receptor binding domain IgG thresholds predict protective host immunity across SARS-CoV-2 variants and time," Nature Communications, Nature, vol. 14(1), pages 1-11, December.
    7. Haonan Yang & Huimin Guo & Aojie Wang & Liwei Cao & Qing Fan & Jie Jiang & Miao Wang & Lin Lin & Xiangyang Ge & Haiyan Wang & Runze Zhang & Ming Liao & Renhong Yan & Bin Ju & Zheng Zhang, 2024. "Structural basis for the evolution and antibody evasion of SARS-CoV-2 BA.2.86 and JN.1 subvariants," Nature Communications, Nature, vol. 15(1), pages 1-14, December.
    8. Franziska K. Kaiser & Mariana Gonzalez Hernandez & Nadine Krüger & Ellinor Englund & Wenjuan Du & Anna Z. Mykytyn & Mathijs P. Raadsen & Mart M. Lamers & Francine Rodrigues Ianiski & Tatiana M. Shamor, 2024. "Filamentous fungus-produced human monoclonal antibody provides protection against SARS-CoV-2 in hamster and non-human primate models," Nature Communications, Nature, vol. 15(1), pages 1-14, December.
    9. Yanqun Wang & An Yan & Deyong Song & Maoqin Duan & Chuangchuang Dong & Jiantao Chen & Zihe Jiang & Yuanzhu Gao & Muding Rao & Jianxia Feng & Zhaoyong Zhang & Ruxi Qi & Xiaomin Ma & Hong Liu & Beibei Y, 2024. "Identification of a highly conserved neutralizing epitope within the RBD region of diverse SARS-CoV-2 variants," Nature Communications, Nature, vol. 15(1), pages 1-15, December.
    10. Laurent Renia & Yun Shan Goh & Angeline Rouers & Nina Bert & Wan Ni Chia & Jean-Marc Chavatte & Siew‐Wai Fong & Zi Wei Chang & Nicole Ziyi Zhuo & Matthew Zirui Tay & Yi-Hao Chan & Chee Wah Tan & Nicho, 2022. "Lower vaccine-acquired immunity in the elderly population following two-dose BNT162b2 vaccination is alleviated by a third vaccine dose," Nature Communications, Nature, vol. 13(1), pages 1-16, December.
    11. Emanuele Andreano & Ida Paciello & Giulio Pierleoni & Giuseppe Maccari & Giada Antonelli & Valentina Abbiento & Piero Pileri & Linda Benincasa & Ginevra Giglioli & Giulia Piccini & Concetta De Santi &, 2023. "mRNA vaccines and hybrid immunity use different B cell germlines against Omicron BA.4 and BA.5," Nature Communications, Nature, vol. 14(1), pages 1-9, December.
    12. Annika Rössler & Antonia Netzl & Ludwig Knabl & Helena Schäfer & Samuel H. Wilks & David Bante & Barbara Falkensammer & Wegene Borena & Dorothee Laer & Derek J. Smith & Janine Kimpel, 2022. "BA.2 and BA.5 omicron differ immunologically from both BA.1 omicron and pre-omicron variants," Nature Communications, Nature, vol. 13(1), pages 1-9, December.
    13. Yuanchen Liu & Xiaoyu Zhao & Jialu Shi & Yajie Wang & Huan Liu & Ye-Fan Hu & Bingjie Hu & Huiping Shuai & Terrence Tsz-Tai Yuen & Yue Chai & Feifei Liu & Hua-Rui Gong & Jiayan Li & Xun Wang & Shujun J, 2024. "Lineage-specific pathogenicity, immune evasion, and virological features of SARS-CoV-2 BA.2.86/JN.1 and EG.5.1/HK.3," Nature Communications, Nature, vol. 15(1), pages 1-17, December.
    14. Lin-Lei Chen & Syed Muhammad Umer Abdullah & Wan-Mui Chan & Brian Pui-Chun Chan & Jonathan Daniel Ip & Allen Wing-Ho Chu & Lu Lu & Xiaojuan Zhang & Yan Zhao & Vivien Wai-Man Chuang & Albert Ka-Wing Au, 2022. "Contribution of low population immunity to the severe Omicron BA.2 outbreak in Hong Kong," Nature Communications, Nature, vol. 13(1), pages 1-10, December.
    15. Jernej Pušnik & Werner O. Monzon-Posadas & Jasmin Zorn & Kathrin Peters & Maximilian Baum & Hannah Proksch & Celina Beta Schlüter & Galit Alter & Tanja Menting & Hendrik Streeck, 2023. "SARS-CoV-2 humoral and cellular immunity following different combinations of vaccination and breakthrough infection," Nature Communications, Nature, vol. 14(1), pages 1-13, December.
    16. Kenneth Danh & Donna Grace Karp & Malvika Singhal & Akshaya Tankasala & David Gebhart & Felipe Jesus Cortez & Devangkumar Tandel & Peter V. Robinson & David Seftel & Mars Stone & Graham Simmons & Anil, 2022. "Detection of neutralizing antibodies against multiple SARS-CoV-2 strains in dried blood spots using cell-free PCR," Nature Communications, Nature, vol. 13(1), pages 1-8, December.
    17. Emanuele Andreano & Ida Paciello & Giulio Pierleoni & Giulia Piccini & Valentina Abbiento & Giada Antonelli & Piero Pileri & Noemi Manganaro & Elisa Pantano & Giuseppe Maccari & Silvia Marchese & Lore, 2023. "B cell analyses after SARS-CoV-2 mRNA third vaccination reveals a hybrid immunity like antibody response," Nature Communications, Nature, vol. 14(1), pages 1-9, December.
    18. Matthew Gagne & Barbara J. Flynn & Christopher Cole Honeycutt & Dillon R. Flebbe & Shayne F. Andrew & Samantha J. Provost & Lauren McCormick & Alex Ry & Elizabeth McCarthy & John-Paul M. Todd & Saran , 2024. "Variant-proof high affinity ACE2 antagonist limits SARS-CoV-2 replication in upper and lower airways," Nature Communications, Nature, vol. 15(1), pages 1-13, December.
    19. Markus Hoffmann & Lok-Yin Roy Wong & Prerna Arora & Lu Zhang & Cheila Rocha & Abby Odle & Inga Nehlmeier & Amy Kempf & Anja Richter & Nico Joel Halwe & Jacob Schön & Lorenz Ulrich & Donata Hoffmann & , 2023. "Omicron subvariant BA.5 efficiently infects lung cells," Nature Communications, Nature, vol. 14(1), pages 1-11, December.
    20. Bin Ju & Qing Fan & Miao Wang & Xuejiao Liao & Huimin Guo & Haiyan Wang & Xiangyang Ge & Lei Liu & Zheng Zhang, 2022. "Antigenic sin of wild-type SARS-CoV-2 vaccine shapes poor cross-neutralization of BA.4/5/2.75 subvariants in BA.2 breakthrough infections," Nature Communications, Nature, vol. 13(1), pages 1-6, December.

    More about this item

    Statistics

    Access and download statistics

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:nat:natcom:v:13:y:2022:i:1:d:10.1038_s41467-022-29909-x. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Sonal Shukla or Springer Nature Abstracting and Indexing (email available below). General contact details of provider: http://www.nature.com .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.