Breakthrough SARS-CoV-2 infections after COVID-19 mRNA vaccination in MS patients on disease modifying therapies during the Delta and the Omicron waves in Italy.

Autor:	Sormani MP; Department of Health Sciences, Section of Biostatistics, University of Genova, Italy; IRCCS Ospedale Policlinico San Martino, Genova, Italy. Electronic address: mariapia.sormani@unige.it., Schiavetti I; Department of Health Sciences, Section of Biostatistics, University of Genova, Italy., Inglese M; IRCCS Ospedale Policlinico San Martino, Genova, Italy; Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DINOGMI) and Center of Excellence for Biomedical Research (CEBR), University of Genoa, Genoa, Italy., Carmisciano L; Department of Health Sciences, Section of Biostatistics, University of Genova, Italy., Laroni A; IRCCS Ospedale Policlinico San Martino, Genova, Italy; Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DINOGMI) and Center of Excellence for Biomedical Research (CEBR), University of Genoa, Genoa, Italy., Lapucci C; IRCCS Ospedale Policlinico San Martino, Genova, Italy; Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DINOGMI) and Center of Excellence for Biomedical Research (CEBR), University of Genoa, Genoa, Italy., Visconti V; Laboratory Medicine, IRCCS Ospedale Policlinico San Martino, Genova, Italy., Serrati C; Department of Neurology, Imperia Hospital, Imperia, Italy., Gandoglia I; Neurology Unit, Galliera Hospital, Italy., Tassinari T; S.C. Neurologia - Ospedale Santa Corona Pietra Ligure (Sv), Italy., Perego G; SC Neurologia ASL 4 Chiavarese, Italy., Brichetto G; AISM Rehabilitation Center, Genoa, Italy., Gazzola P; Centro Sclerosi Multipla S.C. Neurologia Asl 3 Genovese, Italy., Mannironi A; Department of Neurology, Sant'Andrea Hospital, La Spezia, Italy., Stromillo ML; Clinica Neurologica e Malattie Neurometaboliche, Università degli Studi di Siena, Italy., Cordioli C; Centro Sclerosi Multipla ASST Spedali Civili di Brescia, Italy., Landi D; Multiple Sclerosis Clinical and Research Unit, Department of Systems Medicine, Tor Vergata University and Hospital, Rome, Italy., Clerico M; Dipartimento di Scienze Cliniche e Biologiche, Università di Torino, Italy., Signoriello E; Centro Sclerosi Multipla, II Clinica Neurologica, Università della Campania Luigi Vanvitelli, Italy., Cocco E; Centro Sclerosi Multipla Ospedale Binaghi Cagliari - ATS Sardegna, Università di Cagliari, Italy., Frau J; Centro Sclerosi Multipla Ospedale Binaghi Cagliari - ATS Sardegna, Università di Cagliari, Italy., Ferrò MT; Neuroimmunology, Center for Multiple Sclerosis, Cerobrovascular Department, Neurological Unit, ASST Crema, Italy., Di Sapio A; Department of Neurology, Regina Montis Regalis Hospital, Mondovì, Italy., Pasquali L; Department of Clinical and Experimental Medicine, Neurology Unit, University of Pisa, Italy., Ulivelli M; Department of Medicine, Surgery and Neuroscience, University of Siena, Italy., Marinelli F; Multiple Sclerosis Center, Fabrizio Spaziani Hospital, Frosinone, Italy., Pizzorno M; Neurologia, Ospedale San Paolo, Savona, Italy., Callari G; UOC Neurologia e Centro SM Fondazione Istituto G. Giglio, Cefalù, Italy., Iodice R; Clinica Neurologica, DSNRO Università Federico II di Napoli, Italy., Liberatore G; Neuromuscular and Neuroimmunology Service, IRCCS Humanitas Research Hospital, Rozzano, Italy., Caleri F; MS Center, Department of Neurology, F. Tappeiner Hospital Meran (BZ), Italy., Repice AM; Department of Neurology 2, Careggi University Hospital, Florence, Italy., Cordera S; Department of Neurology, Ospedale Regionale, Aosta, Italy., Battaglia MA; Research Department, Italian Multiple Sclerosis Foundation, Genoa, Italy; Department of Life Sciences, University of Siena, Italy., Salvetti M; Centre for Experimental Neurological Therapies (CENTERS), Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome, Italy; IRCCS Istituto Neurologico Mediterraneo Neuromed, Pozzilli, Italy., Franciotta D; Autoimmunology Laboratory, IRCCS Ospedale Policlinico San Martino, Genoa, Italy., Uccelli A; IRCCS Ospedale Policlinico San Martino, Genova, Italy; Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DINOGMI) and Center of Excellence for Biomedical Research (CEBR), University of Genoa, Genoa, Italy.
Jazyk:	angličtina
Zdroj:	EBioMedicine [EBioMedicine] 2022 Jun; Vol. 80, pp. 104042. Date of Electronic Publication: 2022 May 05.
DOI:	10.1016/j.ebiom.2022.104042
Abstrakt:	Background: In this study we aimed to monitor the risk of breakthrough SARS-CoV-2 infection in patients with MS (pwMS) under different DMTs and to identify correlates of reduced protection. Methods: This is a prospective Italian multicenter cohort study, long-term clinical follow-up of the CovaXiMS (Covid-19 vaccine in Multiple Sclerosis) study. 1855 pwMS scheduled for SARS-CoV-2 mRNA vaccination were enrolled and followed up to a mean time of 10 months. The cumulative incidence of breakthrough Covid-19 cases in pwMS was calculated before and after December 2021, to separate the Delta from the Omicron waves and to account for the advent of the third vaccine dose. Findings: 1705 pwMS received 2 m-RNA vaccine doses, 21/28 days apart. Of them, 1508 (88.5%) had blood assessment 4 weeks after the second vaccine dose and 1154/1266 (92%) received the third dose after a mean interval of 210 days (range 90-342 days) after the second dose. During follow-up, 131 breakthrough Covid-19 infections (33 during the Delta and 98 during the Omicron wave) were observed. The probability to be infected during the Delta wave was associated with SARS-CoV-2 antibody levels measured after 4 weeks from the second vaccine dose (HR=0.57, p < 0.001); the protective role of antibodies was preserved over the whole follow up (HR=0.57, 95%CI=0.43-0.75, p < 0.001), with a significant reduction (HR=1.40, 95%CI=1.01-1.94, p=0.04) for the Omicron cases. The third dose significantly reduced the risk of infection (HR=0.44, 95%CI=0.21-0.90,p=0.025) during the Omicron wave. Interpretation: The risk of breakthrough SARS-CoV-2 infections is mainly associated with reduced levels of the virus-specific humoral immune response. Funding: Supported by FISM - Fondazione Italiana Sclerosi Multipla - cod. 2021/Special-Multi/001 and financed or co-financed with the '5 per mille' public funding. (Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)
Databáze:	MEDLINE
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