| Autor: |
Alessandra Vergori, Giulia Matusali, Eleonora Cimini, Licia Bordi, Paola Borrelli, Simone Lanini, Roberta Palazzi, Jessica Paulicelli, Davide Mariotti, Valentina Mazzotta, Stefania Notari, Rita Casetti, Massimo Francalancia, Silvia Rosati, Alessandra D’Abramo, Cosmina Mija, Paola Mencarini, Eugenia Milozzi, Emanuela Caraffa, Simona Sica, Elisabetta Metafuni, Federica Sorà, Angela Rago, Agostina Siniscalchi, Elisabetta Abruzzese, Mariagrazia Garzia, Giovanni Luzi, Roberta Battistini, Luca Prosperini, Antonella Cingolani, Enrico Girardi, Fabrizio Maggi, Andrea Antinori |
| Jazyk: |
angličtina |
| Rok vydání: |
2024 |
| Předmět: |
|
| Zdroj: |
Vaccines, Vol 12, Iss 7, p 784 (2024) |
| Druh dokumentu: |
article |
| ISSN: |
2076-393X |
| DOI: |
10.3390/vaccines12070784 |
| Popis: |
Objective. We aimed to report the real-world use and outcomes over time in immunocompromised individuals receiving tixagevimab/cilgavimab (T/C) pre-exposure prophylaxis (PrEP). Methods. This observational study included participants who received T/C PrEP, categorized into three groups: (i) No COVID-19 (NoC), i.e., participants who never had COVID-19; (ii) Hybrids (H), i.e., participants who had COVID-19 before PrEP; and (iii) Break-through Infections (BTIs), i.e., participants who had COVID-19 after PrEP. The study measured several immune markers at the administration of T/C (T0) at 3 (T1), 6 (T2), and 9 (T3) months afterward. These markers included: anti-receptor-binding domain (RBD) IgG antibodies; BA.5-neutralizing antibodies (nAbs); mucosal IgG; and T cell immunity. The incidence rate ratios for BTIs were analyzed using a Poisson regression model. Results. A total of 231 participants with a median age of 63 years (IQR 54.0–73.0). were included. Among these, 84% had hematological diseases and received a median of three vaccine doses. N = 72 participants belonged to the NoC group, N = 103 to the H group, and n = 56 to the BTI group (24%), with most BTIs being mild/moderate. The incidence rate (IR) of BTIs was 4.2 per 100 patient-months (95% CI 3.2–5.4), with no associated risk factors identified. There was a significant increase in anti-RBD IgG levels 3 months after the T/C administration in all groups, followed by a decline at 6 months, whereas at the same time points, geometric mean titers (GMTs) of anti-BA.5 nAbs were low for all groups and were around or below the detection threshold. No significant changes were observed in IFN-γ levels. The mucosal immune response was observed only 3 months after the PrEP administration. Conclusion. We provided a real-world experience model on the clinical efficacy of T/C PrEP in preventing severe COVID-19 during the Omicron wave through a comprehensive virological and immunological study. While waiting for the arrival of new monoclonal antibodies that can effectively neutralize the most recent variants, T/C PrEP remains the only viable strategy in the available armamentarium today to prevent COVID-19 complications in an extremely fragile population with suboptimal immune responses to COVID-19 vaccines. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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