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
- Creators
- Sormani M. P.
- Schiavetti I.
- Inglese M.
- Carmisciano L.
- Laroni A.
- Lapucci C.
- Visconti V.
- Serrati C.
- Gandoglia I.
- Tassinari T.
- Perego G.
- Brichetto G.
- Gazzola P.
- Mannironi A.
- Stromillo M. L.
- Cordioli C.
- Landi D.
- Clerico M.
- Signoriello E.
- Cocco E.
- Frau J.
- Ferro M. T.
- Di Sapio A.
- Pasquali L.
- Ulivelli M.
- Marinelli F.
- Pizzorno M.
- Callari G.
- Iodice R.
- Liberatore G.
- Caleri F.
- Repice A. M.
- Cordera S.
- Battaglia M. A.
- Salvetti M.
- Franciotta D.
- Uccelli A.
- Others:
- Sormani, M. P.
- Schiavetti, I.
- Inglese, M.
- Carmisciano, L.
- Laroni, A.
- Lapucci, C.
- Visconti, V.
- Serrati, C.
- Gandoglia, I.
- Tassinari, T.
- Perego, G.
- Brichetto, G.
- Gazzola, P.
- Mannironi, A.
- Stromillo, M. L.
- Cordioli, C.
- Landi, D.
- Clerico, M.
- Signoriello, E.
- Cocco, E.
- Frau, J.
- Ferro, M. T.
- Di Sapio, A.
- Pasquali, L.
- Ulivelli, M.
- Marinelli, F.
- Pizzorno, M.
- Callari, G.
- Iodice, R.
- Liberatore, G.
- Caleri, F.
- Repice, A. M.
- Cordera, S.
- Battaglia, M. A.
- Salvetti, M.
- Franciotta, D.
- Uccelli, A.
Description
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
Additional details
- URL
- http://hdl.handle.net/11567/1083338
- URN
- urn:oai:iris.unige.it:11567/1083338
- Origin repository
- UNIGE