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

Simone Lanini, Stefano Milleri, Emanuele Andreano, Sarah Nosari, Ida Paciello, Giulia Piccini, Alessandra Gentili, Adhuna Phogat, Inesa Hyseni, Margherita Leonardi, Alessandro Torelli, Emanuele Montomoli, Andrea Paolini, Andrea Frosini, Andrea Antinori, Emanuele Nicastri, Enrico Girardi, Maria Maddalena Plazzi, Giuseppe Ippolito, Francesco VaiaGiovanni Della Cioppa, Rino Rappuoli

Research output: Contribution to journalArticlepeer-review


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 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.

Original languageEnglish
Article number2263
Pages (from-to)1-8
Number of pages8
JournalNature Communications
Issue number1
Publication statusPublished - Dec 2022

ASJC Scopus subject areas

  • Chemistry(all)
  • Biochemistry, Genetics and Molecular Biology(all)
  • Physics and Astronomy(all)


Dive into the research topics of 'Safety and serum distribution of anti-SARS-CoV-2 monoclonal antibody MAD0004J08 after intramuscular injection'. Together they form a unique fingerprint.

Cite this