turchEtti 34 , donatella bonaiuti 35 on behalf of italian consensus conference on robotics in neurorehabilitation (cicEronE)1 irccs centro neurolesi bonino-pulejo, Messina, italy; 2 department of Medicine and rehabilitation, polyclinic of Monza, Monzabrianza, italy; 3 spinal cord unit and intensive rehabilitation Medicine, ausl piacenza, Villanova sull'arda and castel san Giovanni, piacenza, italy; 4 Gait and Motion analysis laboratory opa sol et salus, torre pedrera, rimini, italy; 5 department of Experimental and clinical Medicine università politecnica delle Marche (uniVpM), ancona, italy; 6 spinal cord unit, department of rehabilitation Medicine, Gervasutta hospital, udine, italy; 7 azienda sanitaria universitaria friuli centrale (asu-fc), udine, italy; 8 neuromotor and rehabilitation department, laM-Motion analysis laboratory, ausl-irccs reggio Emilia, reggio Emilia, italy; 9 rehabilitation therapeutic center, tramutola, potenza, italy; 10 irccs a. Gemelli university polyclinic foundation, rome, italy; 11 section of neurorehabilitation, department of translational research and new technologies in Medicine and surgery, university of pisa, pisa, italy; 12 Montecatone rehabilitation institute, imola, bologna, italy; 13 unit of neurophysiopathology, ics Maugeri, Montescano institute, pavia, italy; 14 centro protesi Vigorso di budrio, istituto nazionale assicurazione infortuni sul lavoro (inail),

Objective To evaluate the SARS-CoV-2 anti-spike IgG antibodies production after the vaccination with BNT162b2 and the protection from symptomatic breakthrough infections in healthcare workers. Patients and methods This prospective observational study (RENAISSANCE) had as primary endpoint the evaluation of serologic response to BNT162b2 14-days after second dose. SARS-CoV-2 anti-spike IgG antibodies were evaluated with LIAISON® SARS-CoV-2 TrimericS IgG assay, able to detect presence of both binding and neutralizing antibodies for trimeric Spike glycoprotein. Subjects were recruited from February 1, 2021 to February 22, 2021. Occurrence of vaccine-breakthrough infections was assessed by RT-PCR on symptomatic/contact cases, up to June 6, 2021. Results Out of 2569 staff only were 4 non-responders (0.16%, 95%CI:0.04%-0.41%). All 4 non-responders were severely immunosuppressed and on treatment with mycophenolate mofetil/mycophenolic acid. At 14-days since 2° dose, the 67.5% of staff had anti-S IgG titers ≥2000 BAU/mL, 19.2% between 1500- 2000 BAU/ml, 9.8% between 1000-1500 BAU/ml, and 3.4% ≤1000 BAU/ml. Females had a higher probability of having higher titers than males (64.5% [1044/1618] vs. 58.3% [410/703]; p=0.005). This was confirmed after adjusting for age group (OR [95%CI]: 1.275 [1.062-1.531]; p=0.009). Four months after the end of vaccination program, only 13 subjects (0.26%) had experienced a breakthrough SARS-CoV-2 infection, including 1 non-responder. This subject was the only requiring hospitalization for severe COVID-19. Conclusion Vaccination campaign among healthcare workers at the ASST GOM Niguarda has resulted in a significative serologic response, and reduction of incident COVID-19 cases. Yet, the lack of protection should not be overlooked in immunocompromised subjects.

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