Immunogenicity and Safety of SARS-CoV-2 mRNA Vaccines in a Cohort of Patients With Type 1 Diabetes
Francesca D'Addio, Gianmarco Sabiu, Vera Usuelli, Emma Assi, Ahmed Abdelsalam, Anna Maestroni, Andy Joe Seelam, Moufida Ben Nasr, Cristian Loretelli, Davide Mileto, Giada Rossi, Ida Pastore, Laura Montefusco, Paola S Morpurgo, Laura Plebani, Antonio Rossi, Enrica Chebat, Andrea M Bolla, Maria Elena Lunati, Chiara Mameli, Maddalena Macedoni, Spinello Antinori, Stefano Rusconi, Maurizio Gallieni, Cesare Berra, Franco Folli, Massimo Galli, Maria Rita Gismondo, Gianvincenzo Zuccotti, Paolo Fiorina, Francesca D'Addio, Gianmarco Sabiu, Vera Usuelli, Emma Assi, Ahmed Abdelsalam, Anna Maestroni, Andy Joe Seelam, Moufida Ben Nasr, Cristian Loretelli, Davide Mileto, Giada Rossi, Ida Pastore, Laura Montefusco, Paola S Morpurgo, Laura Plebani, Antonio Rossi, Enrica Chebat, Andrea M Bolla, Maria Elena Lunati, Chiara Mameli, Maddalena Macedoni, Spinello Antinori, Stefano Rusconi, Maurizio Gallieni, Cesare Berra, Franco Folli, Massimo Galli, Maria Rita Gismondo, Gianvincenzo Zuccotti, Paolo Fiorina
Abstract
Patients with type 1 diabetes (T1D) may develop severe outcomes during coronavirus disease 2019 (COVID-19), but their ability to generate an immune response against the SARS-CoV-2 mRNA vaccines remains to be established. We evaluated the safety, immunogenicity, and glycometabolic effects of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mRNA vaccines in patients with T1D. A total of 375 patients (326 with T1D and 49 subjects without diabetes) who received two doses of the SARS-CoV-2 mRNA vaccines (mRNA-1273, BNT162b2) between March and April 2021 at ASST Fatebenefratelli Sacco were included in this monocentric observational study. Local and systemic adverse events were reported in both groups after SARS-CoV-2 mRNA vaccination, without statistical differences between them. While both patients with T1D and subjects without diabetes exhibited a parallel increase in anti-SARS-CoV-2 spike titers after vaccination, the majority of patients with T1D (70% and 78%, respectively) did not show any increase in the SARS-CoV-2-specific cytotoxic response compared with the robust increase observed in all subjects without diabetes. A reduced secretion of the T-cell-related cytokines interleukin-2 and tumor necrosis factor-α in vaccinated patients with T1D was also observed. No glycometabolic alterations were evident in patients with T1D using continuous glucose monitoring during follow-up. Administration of the SARS-CoV-2 mRNA vaccine is associated with an impaired cellular SARS-CoV-2-specific cytotoxic immune response in patients with T1D.
Trial registration: ClinicalTrials.gov NCT04905823.
© 2022 by the American Diabetes Association.
Source: PubMed