PMID- 36266209 OWN - NLM STAT- MEDLINE DCOM- 20230201 LR - 20230325 IS - 1878-3562 (Electronic) IS - 1590-8658 (Print) IS - 1590-8658 (Linking) VI - 55 IP - 2 DP - 2023 Feb TI - Spike-specific humoral and cellular immune responses after COVID-19 mRNA vaccination in patients with cirrhosis: A prospective single center study. PG - 160-168 LID - S1590-8658(22)00701-0 [pii] LID - 10.1016/j.dld.2022.09.010 [doi] AB - BACKGROUND AND AIMS: COVID-19 mRNA vaccines were approved to prevent severe forms of the disease, but their immunogenicity and safety in cirrhosis is poorly known. METHOD: In this prospective single-center study enrolling patients with cirrhosis undergoing COVID-19 vaccination (BNT162b2 and mRNA-1273), we assessed humoral and cellular responses vs healthy controls, the incidence of breakthrough infections and adverse events (AEs). Antibodies against spike- and nucleocapsid-protein (anti-S and anti-N) and Spike-specific T-cells responses were quantified at baseline, 21 days after the first and second doses and during follow-up. RESULTS: 182 cirrhotics (85% SARS-CoV-2-naive) and 38 controls were enrolled. After 2 doses of vaccine, anti-S titres were significantly lower in cirrhotics vs controls [1,751 (0.4-25,000) U/mL vs 4,523 (259-25,000) U/mL, p=0.012] and in SARS-CoV-2-naive vs previously infected cirrhotics [999 (0.4-17,329) U/mL vs 7,500 (12.5-25,000) U/mL, (p<0.001)]. T-cell responses in cirrhotics were similar to controls, although with different kinetics. In SARS-CoV-2-naive cirrhotics, HCC, Child-Pugh B/C and BNT162b2 were independent predictors of low response. Neither unexpected nor severe AEs emerged. During follow-up, 2% turned SARS-CoV-2 positive, all asymptomatic. CONCLUSION: Humoral response to COVID-19 vaccines appeared suboptimal in patients with cirrhosis, particularly in SARS-CoV-2-naive decompensated cirrhotics, although cellular response appeared preserved, and low breakthrough infections rate was registered. CI - Copyright (c) 2022 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved. FAU - Iavarone, Massimo AU - Iavarone M AD - Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy. Electronic address: massimo.iavarone@policlinico.mi.it. FAU - Tosetti, Giulia AU - Tosetti G AD - Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy. FAU - Facchetti, Floriana AU - Facchetti F AD - Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy. FAU - Topa, Matilde AU - Topa M AD - Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy. FAU - Er, Joey Ming AU - Er JM AD - Programme in Emerging Infectious Diseases, Duke-NUS Medical School, Singapore. FAU - Hang, Shou Kit AU - Hang SK AD - Programme in Emerging Infectious Diseases, Duke-NUS Medical School, Singapore. FAU - Licari, Debora AU - Licari D AD - Clinical Laboratory, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy. FAU - Lombardi, Andrea AU - Lombardi A AD - Infectious Diseases Unit, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy; Department of Pathophysiology and Transplantation, University of Milano, Milano, Italy. FAU - D'Ambrosio, Roberta AU - D'Ambrosio R AD - Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy. FAU - Degasperi, Elisabetta AU - Degasperi E AD - Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy. FAU - Loglio, Alessandro AU - Loglio A AD - Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy. FAU - Oggioni, Chiara AU - Oggioni C AD - IRCCS Humanitas Research Hospital, Quality and Patient Safety Unit, Rozzano, Milano, Italy. FAU - Perbellini, Riccardo AU - Perbellini R AD - Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy. FAU - Caccia, Riccardo AU - Caccia R AD - Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy. FAU - Bandera, Alessandra AU - Bandera A AD - Infectious Diseases Unit, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy; Department of Pathophysiology and Transplantation, University of Milano, Milano, Italy. FAU - Gori, Andrea AU - Gori A AD - Infectious Diseases Unit, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy; Department of Pathophysiology and Transplantation, University of Milano, Milano, Italy. FAU - Ceriotti, Ferruccio AU - Ceriotti F AD - Clinical Laboratory, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy. FAU - Scudeller, Luigia AU - Scudeller L AD - Research and Innovation Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy. FAU - Bertoletti, Antonio AU - Bertoletti A AD - Programme in Emerging Infectious Diseases, Duke-NUS Medical School, Singapore; Singapore Immunology Network, A*STAR, Singapore. FAU - Lampertico, Pietro AU - Lampertico P AD - Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy; CRC "A. M. and A. Migliavacca" Center for Liver Disease, Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy. LA - eng PT - Journal Article DEP - 20221017 PL - Netherlands TA - Dig Liver Dis JT - Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver JID - 100958385 RN - 0 (Antibodies) RN - 0 (Antibodies, Viral) RN - 0 (BNT162 Vaccine) RN - 0 (COVID-19 Vaccines) RN - 0 (RNA, Messenger) SB - IM MH - Humans MH - Antibodies MH - Antibodies, Viral MH - BNT162 Vaccine MH - Breakthrough Infections MH - *Carcinoma, Hepatocellular MH - *COVID-19/prevention & control MH - *COVID-19 Vaccines/adverse effects MH - Immunity, Cellular MH - Liver Cirrhosis MH - *Liver Neoplasms MH - Prospective Studies MH - RNA, Messenger MH - SARS-CoV-2 MH - Vaccination PMC - PMC9575378 OTO - NOTNLM OT - Hepatitis B OT - Hepatitis C OT - Hepatocellular carcinoma OT - Moderna mRNA-1273 OT - Nucleocapsid-protein OT - Pfizer-BioNTech BNT162b2 OT - Portal hypertension OT - SARS-CoV-2 OT - Spike-protein COIS- Conflict of interest MI: Speaking/Teaching, consultant and advisory board for Bayer, Gilead Sciences, BMS, Janssen, Ipsen, MSD, BTG-Boston Scientific, AbbVie, Guerbet, EISAI, Roche. BA: A patent for a method to monitor SARS-CoV-2-specific T-cells in biological samples pending. PL: Advisory Board/Speaker Bureau for BMS, ROCHE, GILEAD SCIENCES, GSK, ABBVIE, MSD, ARROWHEAD, ALNYLAM, JANSSEN, SBRING BANK, MYR, EIGER, ALIGOS, ANTIOS, VIR. EDAT- 2022/10/21 06:00 MHDA- 2023/02/01 06:00 PMCR- 2022/10/17 CRDT- 2022/10/20 22:08 PHST- 2022/06/21 00:00 [received] PHST- 2022/09/10 00:00 [revised] PHST- 2022/09/12 00:00 [accepted] PHST- 2022/10/21 06:00 [pubmed] PHST- 2023/02/01 06:00 [medline] PHST- 2022/10/20 22:08 [entrez] PHST- 2022/10/17 00:00 [pmc-release] AID - S1590-8658(22)00701-0 [pii] AID - 10.1016/j.dld.2022.09.010 [doi] PST - ppublish SO - Dig Liver Dis. 2023 Feb;55(2):160-168. doi: 10.1016/j.dld.2022.09.010. Epub 2022 Oct 17.