Department of Health Sciences, Section of Biostatistics, University of Genova, Italy; IRCCS Ospedale Policlinico San Martino, Genova, Italy.
Department of Health Sciences, Section of Biostatistics, University of Genova, Italy.
EBioMedicine. 2022 Jun;80:104042. doi: 10.1016/j.ebiom.2022.104042. Epub 2022 May 5.
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.
本研究旨在监测不同疾病修正治疗（DMT）方案下多发性硬化症（MS）患者突破性 SARS-CoV-2 感染的风险，并确定保护作用降低的相关因素。
这是一项前瞻性意大利多中心队列研究，为 CovaXiMS（COVID-19 疫苗在多发性硬化症中的应用）研究的长期临床随访。1855 名计划接种 SARS-CoV-2 mRNA 疫苗的 MS 患者入组并随访平均 10 个月。在 2021 年 12 月之前和之后分别计算 MS 患者突破性 COVID-19 病例的累积发生率，以区分 Delta 和 Omicron 波，并考虑到第三剂疫苗的出现。
1705 名 MS 患者接受了 2 剂 mRNA 疫苗，间隔 28 天。其中，1508 名（88.5%）在第二次疫苗接种后 4 周进行了血液评估，1154 名（92%）在第二次疫苗接种后平均 210 天（90-342 天）后接受了第三剂疫苗。在随访期间，观察到 131 例突破性 COVID-19 感染（Delta 波 33 例，Omicron 波 98 例）。Delta 波期间感染的概率与第二次疫苗接种后 4 周测量的 SARS-CoV-2 抗体水平相关（HR=0.57，p<0.001）；抗体的保护作用在整个随访期间得到保留（HR=0.57，95%CI=0.43-0.75，p<0.001），对于 Omicron 病例，保护作用显著降低（HR=1.40，95%CI=1.01-1.94，p=0.04）。第三剂疫苗显著降低了 Omicron 波期间的感染风险（HR=0.44，95%CI=0.21-0.90，p=0.025）。
突破性 SARS-CoV-2 感染的风险主要与病毒特异性体液免疫反应水平降低有关。
突破性 SARS-CoV-2 感染的风险主要与病毒特异性体液免疫反应水平降低有关。
由 FISM - Fondazione Italiana Sclerosi Multipla（意大利多发性硬化症基金会）- cod. 2021/Special-Multi/001 支持，并由“5 per mille”公共资金资助或共同资助。
