PMID- 37238990 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230530 IS - 2227-9059 (Print) IS - 2227-9059 (Electronic) IS - 2227-9059 (Linking) VI - 11 IP - 5 DP - 2023 Apr 28 TI - Humoral Immune Response after COVID-19 mRNA Vaccination in Patients with Liver Cirrhosis: A Prospective Real-Life Single Center Study. LID - 10.3390/biomedicines11051320 [doi] LID - 1320 AB - Coronavirus-disease-2019 (COVID-19) mRNA vaccination effectively reduces mortality and morbidity in cirrhotic patients, but the immunogenicity and safety of vaccination have been partially characterized. The study aimed to evaluate humoral response, predictive factors, and safety of mRNA-COVID-19 vaccination in cirrhotic patients compared to healthy subjects. A prospective, single-center, observational study enrolled consecutive cirrhotic patients who underwent mRNA-COVID-19 vaccination from April to May 2021. Anti-spike-protein (anti-S) and nucleocapsid-protein (anti-N) antibodies were evaluated before the first (T0) and the second (T1) doses and 15 days after completing the vaccination. An age and sex-matched healthy reference group was included. The incidence of adverse events (AEs) was assessed. In total, 162 cirrhotic patients were enrolled, 13 were excluded due to previous SARS-CoV-2 infection; therefore, 149 patients and 149 Health Care Workers (HCWs) were included in the analysis. The seroconversion rate was similar in cirrhotic patients and HCWs at T1 (92.5% vs. 95.3%, p = 0.44) and T2 (100% in both groups). At T2, anti-S-titres were significantly higher in cirrhotic patients compared to HCWs (2776.6 vs. 1756 BAU/mL, p < 0.001]. Male sex (beta = -0.32 [-0.64, -0.04], p = 0.027) and past-HCV-infection (beta = -0.31 [-0.59, -0.04], p = 0.029) were independent predictors of lower anti-S-titres on multiple-gamma-regression-analysis. No severe AEs occurred. The COVID-19-mRNA vaccination induces a high immunization rate and anti-S-titres in cirrhotic patients. Male sex and past-HCV infection are associated with lower anti-S-titres. The COVID-19-mRNA vaccination is safe. FAU - Biliotti, Elisa AU - Biliotti E AUID- ORCID: 0000-0002-4540-1815 AD - Infectious Diseases Hepatology Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy. FAU - Caioli, Alessandro AU - Caioli A AUID- ORCID: 0000-0003-2097-9116 AD - Infectious Diseases Hepatology Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy. FAU - Sorace, Chiara AU - Sorace C AD - Infectious Disease Clinic, Policlinico Tor Vergata, 00133 Rome, Italy. FAU - Lionetti, Raffaella AU - Lionetti R AUID- ORCID: 0000-0003-2827-4591 AD - Infectious Diseases Hepatology Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy. FAU - Milozzi, Eugenia AU - Milozzi E AUID- ORCID: 0009-0001-1424-4618 AD - Infectious Diseases Hepatology Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy. FAU - Taibi, Chiara AU - Taibi C AUID- ORCID: 0000-0003-2556-1560 AD - Infectious Diseases Hepatology Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy. FAU - Visco Comandini, Ubaldo AU - Visco Comandini U AUID- ORCID: 0000-0003-0460-8024 AD - Infectious Diseases Hepatology Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy. FAU - Maggi, Fabrizio AU - Maggi F AUID- ORCID: 0000-0001-7489-5271 AD - Laboratory of Virology, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy. FAU - Puro, Vincenzo AU - Puro V AUID- ORCID: 0000-0003-0291-4490 AD - Risk Management Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy. FAU - D'Offizi, Gianpiero AU - D'Offizi G AUID- ORCID: 0000-0002-0091-3585 AD - Infectious Diseases Hepatology Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy. LA - eng PT - Journal Article DEP - 20230428 PL - Switzerland TA - Biomedicines JT - Biomedicines JID - 101691304 PMC - PMC10215518 OTO - NOTNLM OT - COVID-19 OT - anti-spike antibodies titres OT - cirrhotic patients OT - humoral response OT - mRNA vaccination OT - male sex OT - past HCV infection COIS- The authors declare no conflict of interest. EDAT- 2023/05/27 09:42 MHDA- 2023/05/27 09:43 PMCR- 2023/04/28 CRDT- 2023/05/27 01:08 PHST- 2023/03/24 00:00 [received] PHST- 2023/04/18 00:00 [revised] PHST- 2023/04/25 00:00 [accepted] PHST- 2023/05/27 09:43 [medline] PHST- 2023/05/27 09:42 [pubmed] PHST- 2023/05/27 01:08 [entrez] PHST- 2023/04/28 00:00 [pmc-release] AID - biomedicines11051320 [pii] AID - biomedicines-11-01320 [pii] AID - 10.3390/biomedicines11051320 [doi] PST - epublish SO - Biomedicines. 2023 Apr 28;11(5):1320. doi: 10.3390/biomedicines11051320.