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.
Breakthrough infections
COVID-19
Disease Modifying Treatments
Multiple Sclerosis
Journal
EBioMedicine
ISSN: 2352-3964
Titre abrégé: EBioMedicine
Pays: Netherlands
ID NLM: 101647039
Informations de publication
Date de publication:
Jun 2022
Jun 2022
Historique:
received:
23
02
2022
revised:
19
04
2022
accepted:
20
04
2022
pubmed:
9
5
2022
medline:
15
6
2022
entrez:
8
5
2022
Statut:
ppublish
Résumé
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. 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. 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. The risk of breakthrough SARS-CoV-2 infections is mainly associated with reduced levels of the virus-specific humoral immune response. Supported by FISM - Fondazione Italiana Sclerosi Multipla - cod. 2021/Special-Multi/001 and financed or co-financed with the '5 per mille' public funding.
Sections du résumé
BACKGROUND
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
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
RESULTS
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
CONCLUSIONS
The risk of breakthrough SARS-CoV-2 infections is mainly associated with reduced levels of the virus-specific humoral immune response.
FUNDING
BACKGROUND
Supported by FISM - Fondazione Italiana Sclerosi Multipla - cod. 2021/Special-Multi/001 and financed or co-financed with the '5 per mille' public funding.
Identifiants
pubmed: 35526306
pii: S2352-3964(22)00223-7
doi: 10.1016/j.ebiom.2022.104042
pmc: PMC9069178
pii:
doi:
Substances chimiques
COVID-19 Vaccines
0
RNA, Messenger
0
Vaccines, Synthetic
0
Viral Vaccines
0
mRNA Vaccines
0
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
104042Investigateurs
Alessandro Maglione
(A)
Alessia Di Sapio
(AD)
Alessio Signori
(A)
Alice Laroni
(A)
Aniello Iovino
(A)
Anna Maria Repice
(A)
Antonio Mannironi
(A)
Antonio Uccelli
(A)
Carlo Serrati
(C)
Carolina Gabri Nicoletti
(C)
Caterina Lapucci
(C)
Chiara Rosa Mancinelli
(CR)
Cinzia Cordioli
(C)
Daiana Bezzini
(D)
Daniele Carmagnini
(D)
Davide Brogi
(D)
Diego Franciotta
(D)
Doriana Landi
(D)
Eduardo Nobile Orazio
(E)
Eleonora Cocco
(E)
Elisabetta Signoriello
(E)
Enri Nako
(E)
Ester Assandrir
(E)
Fabiana Marinelli
(F)
Federica Baldi
(F)
Filippo Ansaldi
(F)
Francesca Bovis
(F)
Francesca Caleri
(F)
Gabriele Siciliano
(G)
Gaia Cola
(G)
Germana Perego
(G)
Giacomo Lus
(G)
Giampaolo Brichetto
(G)
Giancarlo Icardi
(G)
Gianmarco Bellucci
(G)
Giorgio Da Rin
(G)
Girolama Alessandra Marfia
(G)
Giulia Vazzoler
(G)
Giuseppe Liberatore
(G)
Giuseppe Trivelli
(G)
Graziella Callari
(G)
Ilaria Gandoglia
(I)
Ilaria Maietta
(I)
Irene Schiavetti
(I)
Jessica Frau
(J)
Laura Sticchi
(L)
Livia Pasquali
(L)
Lorena Lorefice
(L)
Luca Carmisciano
(L)
Lucia Ruggiero
(L)
Marcello Manzino
(M)
Marco Salvetti
(M)
Margherita Monti Bragadin
(M)
Maria Chiara Buscarinu
(M)
Maria Gagliardi
(M)
Maria Laura Stromillo
(M)
Maria Pia Sormani
(M)
Maria Teresa Ferrò
(MT)
Maria Teresa Rilla
(MT)
Marinella Clerico
(M)
Mario Alberto Battaglia
(M)
Marta Ponzano
(M)
Marzia Fronza
(M)
Massimo Del Sette
(M)
Matilde Inglese
(M)
Matteo Scialabba
(M)
Michele Bedognetti
(M)
Monica Ulivelli
(M)
Nicola De Rossi
(N)
Nicola De Stefano
(N)
Paola Gazzola
(P)
Rachele Bigi
(R)
Raffaele Dubbioso
(R)
Roberta Reniè
(R)
Rosa Iodice
(R)
Sabrina Fabbri
(S)
Sarah Rasia
(S)
Simona Rolla
(S)
Stefan Platzgummer
(S)
Susanna Cordera
(S)
Tiziana Tassinari
(T)
Valentina Carlini
(V)
Informations de copyright
Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.
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