Abstract
Background
The aim of this study was to evaluate the efficacy and safety of COVID-19 vaccines in patients undergoing haemodialysis in Italy compared to the general population.
Methods
In this cohort study, 118 dialysis centres from 18 Italian Regions participated. Individuals older than 16 years on dialysis treatment for at least 3 months, who provided informed consent were included. We collected demographic and clinical information, as well as data on vaccination status, hospitalisations, access to intensive care units and adverse events. We calculated the incidence, hospitalisation, mortality, and fatality rates in the vaccinated dialysis cohort, adjusted for several covariates. The incidence rates of infection in the dialysis cohort and the general population were compared through Standardised Incidence Rate Ratio.
Results
The study included 6555 patients vaccinated against SARS-CoV-2 infection according to the schedule recommended in Italy. Between March 2021 and May 2022, there were 1096 cases of SARS-CoV-2 infection, with an incidence rate after completion of the three-dose vaccination cycle of 37.7 cases per 100 person-years. Compared to the general population, we observed a 14% reduction in the risk of infection for patients who received three vaccine doses (Standardised Incidence Rate Ratio: 0.86; 95% Confidence Interval: 0.81–0.91), whereas no statistically significant differences were found for COVID-19-related hospitalisations, intensive care unit admissions or death. No safety signals emerged from the reported adverse events.
Conclusions
The vaccination program against SARS-CoV-2 in the haemodialysis population showed an effectiveness and safety profile comparable to that seen in the general population.
Graphical abstract
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Data availability
Data may be shared upon reasonable request to the authors.
Change history
20 December 2023
A Correction to this paper has been published: https://doi.org/10.1007/s40620-023-01864-w
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Acknowledgements
We thank Raffaella D’Arcangelo, Claudia Valletta (Società Italiana di Nefrologia) and Emanuela Salvi (Italian National Institute of Health, Rome) for their invaluable technical support during all phases of the study. COVIDVaxDia Study Group: Francesca Menniti-Ippolito, Roberto Da Cas, Flavia Chiarotti, Massimo Fabiani, Giuseppe Traversa (Italian National Institute of Health, Rome, Italy), Piergiorgio Messa (Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico di Milano), Alfonso Mele (Epidemiologist, retired from Italian National Institute of Health, Rome, Italy), Salvatore De Masi (Clinical Trial Centre, Careggi Hospital, Florence, Italy), Francesca Colavita (Laboratory of Virology, National Institute for Infectious Diseases Lazzaro Spallanzani, IRCCS, Rome, Italy), Concetta Castilletti (Department of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar di Valpolicella, Verona, Italy), Carmine Zoccali (Associazione Ipertensione, Nefrologia e Trapianto Renale (IPNET) c/o Nefrologia, Reggio Calabria, Italy), Aldo Pietro Maggioni, Andrea Lorimer, Martina Ceseri, Ester Baldini, Francesca Bianchini, Laura Sarti (ANMCO Research Center, Heart Care Foundation Onlus, Florence, Italy), Giovanni Baglio (Italian National Agency for Regional Healthcare Services, Rome, Italy), Andrea Mariano (National Institute for Infectious Diseases Lazzaro Spallanzani, IRCCS, Rome, Italy), Eva Alessi (Italian Medicine Agency, Rome, Italy). Dialysis clinical centres: SS Annunziata—Chieti: Lorenzo Di Liberato, Ospedale Civile "G. Mazzini"—Teramo: Luigi Amoroso, Nicola Spetrino, Milva Di Giovanni; Ospedale Ferrari—Castrovillari (CS): Carlo Sapio, Irma Figlia, Roberto Pititto; Azienda Ospedaliera di Cosenza: Teresa Papalia, Rosita Greco, Francesca Leone; Giovanni Paolo II—Lamezia Terme: Francesco Maria D’Agostino, Maria Angela Campolo, Maria Rosa La Gamba; Grande Ospedale Metropolitano—Reggio Calabria: Francesca Mallamaci, Vincenzo Panuccio, Giovanna Parlongo; G. Jazzolino—Vibo Valentia: Giuseppe Natale, Domenico Tramontana, Ivania Figliano; Nephrocare—Angri: Santo Vitiello, Annamaria Frangiosa; AORN Sant’Anna e San Sebastiano—Caserta: Domenico Caserta, Pasqualina Acconcia, Nunzia Paudice; Centro Medico Metelliano—Cava dei Tirreni (SA): Alfonso De Maio, Salvatore Cascone, Marilina Siani; NephroCare S.p.A.- Cercola (NA): Mario Cioffi, Nataliya Romanyuk, Franca Pagnano; NephroCare S.p.A.- Fisciano (NA): Antonio De Donato; Ambulatorio di Emodialisi Nefrocenter, Frattamaggiore (NA): Ersilia Satta; AUO Policlinico Vanvitelli—Napoli: Alessandra Perna, Francesco Trepiccione, Alessandro Cerrone; Nephrocare S.p.A.—Napoli: Gianluca Garofalo; Nephrocare—Napoli: Giancarlo Marinelli;Nephrocare S.p.A.- Napoli: Roberta D’amato; Nephrocare—Napoli: Enrico De Felice, Alfredo Vacca; P.O. Piedimonte Matese—Caserta: Salvatore Coppola, Vincenzo Cuomo; Nephrocare S.P.A.—Pozzuoli (NA): Maria Palma Iavarone; NephroCare S.P.A.—Quarto (NA): Annalisa Ciotola; NephroCare S.P.A.—Roccadaspide (SA): Vincenzo Puglia, Pio Granato; Nephrocare Emodial—Salerno: Carla Lamberti, Giorgio Capasso NephroCare S.p.A.—Salerno: Domenico Bonanno, Marco Ventre, Veronica Amendola Nephrocare—Torre del Greco (NA): Fabio Cappabianca; IRCCS-Azienda Ospedaliero-Universitaria Policlinico S. Orsola—Bologna: Elena Mancini, Davide Ricci, Daniela Cecilia Cannarile, Roberta Benevento, Bianca Perciaccante; AOU Sant’Anna -Cona (FE): Alda Storari, Yuri Battaglia, Giovanni Piva; Ospedali di Forlì e Cesena—Forlì: Giovanni Mosconi, Alessandra Spazzoli, Paolo Ferdinando Bruno, Katia Ambri, Barbara Veterani, Sara Signorotti; S. Maria della Scaletta—Imola: Marcora Mandreoli, Renato Mario Rapanà, Maria Teresa Benedetto, Laura Patregnani, Maddalena Zambelli; Azienda Ospedaliero-Universitaria di Modena: Gaetano Alfano; Azienda USL – IRCCS di Reggio Emilia, Nephrology and Dialysis Unit: Silvia Mattei, Francesco Iannuzzella, Elena Pelizzaro, Luca Camparini, Giuseppe Battaglino, Mariacristina Gregorini; San Daniele—Tolmezzo (UD): Dino Romanini, Antonio Irlando, Lojze Celik, Giuseppa Natale; Centro Dialisi Ambulatoriale Geramed Srl—Fiano Romano (RM): Maria Cristina Torre, Ilaria Umbro; Casa di cura Nuova Itor—Roma: Nicola Pirozzi, Loredana Fazzari, Lucia Pantano; Ospedale Sandro Pertini—Roma: Antonio Paone, Marco Galliani, Veronica Baglio, Eleonora Moscaritolo, Sabrina Fierimonte, Maria De Cristofaro, Elena Nebuloso; Azienda Ospedaliero—Universitaria Sant’Andrea—Roma: Paolo Menè, Francesca Romana Festuccia, Giulia Talarico, Claudia Fofi, Maria Elena Bracaccia; SS Trinità—Sora (FR): Ernesto Anselmo Cioffi, Fabio Mazza; San Giovanni Evangelista—Tivoli (RM): Pasquale Polito, David Micarelli, Roberto Addesse, Lida Tartaglione; Belcolle—Viterbo: Sandro Feriozzi, Francesca Romana Della Rovere, Natalia Chipilova, Micol Manzuoli; Ospedali Villa Scassi (Genova) e La Colletta (Arenzano, GE): Paolo Sacco, Francesca Ansaldo, Chiara Bottaro, Sonia Marre; IRCCS Ospedale Policlinico San Martino—Genova: Francesca Viazzi, Valeria Falqui, Novella Conti, Angelica Parodi, Valentina Zanetti, Francesca Cappadona, Andrea Speciale; Ospedale S. Paolo—Savona: Giancarlo Mancuso, Monica Repetto, Emanuela Chiara Vigo, Anna Maria Murgia; Papa Giovanni XXIII—Bergamo: Piero Ruggenenti, Patrizia Ondei, Carmela Giuseppina Condemi, Silvia Bernardi; ASST Spedali Civili di Brescia: Francesco Scolari, Paola Gaggia, Federico Alberici, Chiara Manenti, Brunella Valzorio, Corrado Camerini, Agnese Gallico, Michela Tonoli, Federico Daffara, Roberto Zubani, Simona Guerini, Mattia Zappa, Nicole Zambetti; San Pellegrino s.r.l.—Castiglione delle Stiviere (MN): Alessandra Dalla Gassa, Paola Baldan, Luca Fraizzoli; ASST Melegnano e della Martesana P.O. "Uboldo" di Cernusco sul Naviglio (Mi): Sergio Bisegna, Nicola Palmieri, Marco Petrilli, Giusy Mandanici, Francesca Serena Stefani; ASST Crema (CR): Valeria Ogliari, Cristina Tantardini; ASST—Cremona: Fabio Malberti, Paola Pecchini; Ospedale A. Manzoni, ASST di Lecco: Vincenzo La Milia; ASST OVEST Milanese Ospedali di Legnano e di Magenta (MI): Carlo Maria Guastoni, Annalisa Neri, Marina Cornacchiari; ASST di Lodi: Marco Farina, Francesco Barbisoni; ASST Santi Paolo e Carlo—Milano: Mario Cozzolino, Matthias Cassia, Michela Frittoli, Lorenza Magagnoli, Rossella De Leonardis, Roberta Casazza; Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico di Milano: Piergiorgio Messa, Simone Vettoretti, Emanuele Grimaldi, Matteo Abinti, Francesca Maria Ida Carminati, Silvia Giuliani, Matteo Benedetti, Nicholas Walter Delfrate, Elisa Colombo, Angela Cervesato; ASST-GOM Niguarda—Milano: Enrico Eugenio Minetti, Alberto Montoli, Chiara Brunati, Valeria Li Bergolis; Presidio Fatebenefratelli—Milano: Maurizio Gallieni, Laura Cosmai, Maria Antonietta Orani, Cristina De Salvo; ASST Fatebenefratelli, PO Sacco—Milano: Maurizio Gallieni, Cristina Airaghi, Monique Buskermolen; IRCCS Ospedale San Raffaele—Milano: Giuseppe Vezzoli, Giorgio Slaviero, Chiara Lanzani; Fondazione IRCCS San Gerardo dei Tintori – Monza: Federico Pieruzzi, Gina Contaldo, Barbara Trezzi; Fondazione IRCCS Policlinico San Matteo—Pavia: Teresa Rampino, Fabrizio Grosjean, Paola Borille; ICS Maugeri SpA SB—Pavia: Ciro Esposito, Giuseppe Sileno, Marta Arazzi; ASST Lariana Osp. Sant’Anna—Como, San Fermo della Battaglia (CO): Gianvincenzo Melfa, Mariagiulia Tettamanti, Anna Tosetti, Marco D’Amico, Maria Giulia Magatti, Silvia Peiti; Nephrocare SPA c/o ASST Bergamo Est—Seriate: Luciano Pedrini, Annalisa Feliciani, Elena Pezzini; IRCCS Multimedica—Sesto San Giovanni (MI): Silvio Volmer Bertoli, Daniele Ciurlino, Silvia Tedoldi, Vania Prettico, Giulia Maria Magn; Vigevano (PV): Antonietta Gazo, Maurizio Nai, Silvia Muciaccia; Ospedale di Vimercate (MB): Graziana Battini, Lino Merlino, Paola Casanova; IRCCS INRCA—Ancona: Federica Lenci, Maddalena Ricci, Roberta Galeazzi, Anna Rita Bonfigli, Fabrizia Lattanzio; Ospedali Riuniti Ancona: Andrea Ranghino, Mauro Valente, Carolina Finale; Civile "Egles Profili"—Fabriano (AN): Eleonora Guerrini, Marta Canonici; Carlo Urbani—Jesi (AN): Stefano Santarelli, Rosa Maria Agostinelli; A.S.T. Pesaro Urbino—Ospedali S. Salvatore Pesaro e S. Croce Fano—Pesaro (PU): Marina Di Luca, Mauro Martello, Cristina Silvestri, Veronica Bertuzzi, Assunta Cardillo, Valentina Nastasi, Sara Belcastro; AO "SS. Antonio e Biagio e Cesare Arrigo"—Alessandria: Marco Manganaro, Emanuele Luigi Parodi, Valentina Vaccaro, Antonella Giolito; Presidio Ospedaliero S.S. Trinità di Borgomanero (NO): Stefano Cusinato, Michele Battista, Elena Ragazzoni, Paola Marcella Carpani; Ospedale Maggiore, ASLTO 5—Chieri (TO): Mario Salomone, Emanuele Stramignoni; ASL TO4 (TO) sede Cirié (TO): Silvana Savoldi, Guido Martina, Marica Magnetti; sede Ivrea (TO) Chiara Deagostini; sede Chivasso (TO), Stefania Bussolino, Federica Ventrella, Sonia Santi, Giacinta Vigilante. ASLCN1—Cuneo: Marita Marengo, Daniela Falconi, Ilaria Serra; AO S. Croce e Carle—Cuneo: Luca Besso, Davide Diena; AOU Maggiore Della Carita’—Novara: Doriana Chiarinotti, Paola David, Luciana Gravellone; Azienda Ospedaliera Ordine Mauriziano di Torino: Corrado Vitale, Silvia Berutti, Silvia Ganci; Martini—Torino: Giulio Cesano, Federica Neve Vigotti; ASL VCO: Maurizio Borzumati, Patrizia Vio, Stefania Gioira; SC Nefrologia e Dialisi, ASL Vercelli: Simonetta Ottone, Oliviero Filiberti; Ente Ecclesiastico Ospedale F. Miulli—Acquaviva delle Fonti (BA): Carlo Lomonte, Vincenzo Montinaro, Vito Pepe, Elisabetta Manno; Bonomo—Andria (BAT): Salvatore Di Paolo, Luigi Natalicchio, Carmela Gallo, Francesca Pansini, Rossella Varvara; Di Venere ASL Bari: Filomena D’Elia, Nicola Coviello, Concetta Prisciandaro, Lucia Vernò; New Dial—Bari: Fernanda Misceo, Pierfelice Zazzera, Antonella Matrella; AOU Consorziale Policlinico di Bari: Loreto Gesualdo, Anna Maria Di Palma, Virginia Pronzo, Federica Cassone; "Dimiccoli"—Barletta: Salvatore Di Paolo, Tiziana Piccolo, Dora Porcelluzzi, Antonella Di Franco, Mario Giannetto, Villani Chiara; "A. Perrino"—Brindisi: Luigi Vernaglione; P.O "Tatarella"—Cerignola e P.O "San Camillo De Lellis "—Manfredonia (FG): Angelo Specchio, Laura Stoico; Dipartimento di Scienze mediche e Chirurgiche—Università di Foggia: Giovanni Stallone, Vincenzo Losappio, Barbara Infante; Valle d’Itria—Martina Franca (TA): Anna Lisa Marangi, Angela Rodio, Christian D’Altri, Luigi Morrone, Francesca Salvatore, Maria Antonietta Perniola, Antonella Netti; Casa Sollievo della Sofferenza IRCCS—San Giovanni Rotondo (FG): Filippo Aucella, Gaetano Ferrara, Anna Rachele Nardella;ASL Taranto, P.O. Centrale S.S. Annunziata di Taranto: Luigi Francesco Pio Morrone, Maria Grazia Corallo, Giuseppina D’Ettorre; Pia Fondazione Cardinal Panico—Tricase (LE): Francesco Caccetta, Davide Gianfreda; Dipartimento di Scienze Mediche e Sanità Pubblica Università degli Studi di Cagliari—A.R.N.A.S. Brotzu Cagliari: Antonello Pani, Gianfranca Cabiddu; Nephrocare Spa—Casoria (NA): Maria Maddalena Romano, Ciro Adamo; P.O. SS Marta e Venera—Acireale (CT): Giovanni Giorgio Battaglia, Barbara Pocorobba, Emanuela Prencipe, Margherita Saraceno, Luana Scuderi; PO "G. di Maria" Avola, (SR): Salvatore Randone, Francesca Bruno, Rossella Rita Marchese; Az. Ospedaliera per l’Emergenza "Cannizzaro"—Catania: Antonio Granata, Daniela Puliatti; Azienda Ospedaliero—Universitaria Policlinico "G. Rodolico San Marco"—Catania: Carmelita Marcantoni, Luca Zanoli, Ambra D’Anca; Aou G Martino—Messina: Domenico Santoro, Guido Gembillo, Alfio Edoardo Giuffrida, Vincenzo Labbozzetta; ARNAS Civico Di Cristina—Palermo: Angelo Tralongo, Gioacchino Li Cavoli, Carmela Zagarrigo; Ospedale di Arezzo, Azienda USL Toscana SudEst—Arezzo: Paolo Conti, Sofia Giovannini, Silvia Farsetti; Santa Maria Annunziata—Bagno a Ripoli (FI): Pietro Claudio Giovanni Dattolo, Aris Tsalouchos, Stefano Michelassi; Istituto Fiorentino di Cura e Assistenza—IF.C.A.—Firenze: Marco Gallo, Irene Bandor; Ospedale Apuane Azienda USL Nordovest Toscana—Massa: Aldo Casani, Nadia Sami, Daniela Riccomi; U.O.S.D. Nefrologia e Dialisi S.O. S. Andrea Massa Marittima A.U.S.L. Toscana sudest: Lorena Traversari; San Maurizio—Bolzano: Maria Grazia Tabbí, Maria Luisa Bonincontro, Vera Bonell; Azienda Provinciale per i Servizi Sanitari (APSS), Trento: Giuliano Brunori, Diana Zarantonello, Alessandro Laudon, Alessia Dalpiaz; Media Valle del Tevere—Assisi—Castiglione del Lago—Todi (PG): Antonio Selvi, Stefania Santoni, Davide Massimiani, Davide Rossi; Azienda Ospedale—Università Padova: Lorenzo Calò, Barbara Rossi, Giuseppe Scaparrotta; UOC Nefrologia e Dialisi, AULSS 5 Polesana, Ospedale SM della Misericordia—Rovigo: Fulvio Fiorini, Valentina Iacono; San Bonifacio (Verona): Carlo Rugiu, Linda Gammaro, Monica Slaviero, Vincenzo Cosentini; Ospedale Ca’ Foncello—Treviso: Maurizio Nordio, Riccarda Maria Puggia, Adriana Caberlotto; SS. Giovanni e Paolo—Venezia: Flavio Scanferla, Vincenzo Casoria, Federica Gramegna; Ospedale di Dolo e Mirano—Venezia: Gina Meneghel, Ilenia Filippi, Anna Giacomini; San Bortolo—Vicenza: Claudio Ronco, Anna Giuliani, Sabrina Milan Manani, Monica Zanella.
Funding
This study was funded by the Italian Medicines Agency (AIFA).
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FMI, AM, RDC, SDM, FC, CC, MS and PM designed the study. FMI, RDC, MS and FC retrieved and prepared the data. RDC and FC carried out the statistical analysis. FMI, AM, RDC, SDM, FC, MF, GB, GT, FC, CC, MS, CZ and PM wrote the manuscript. All authors critically revised and approved the final version of the manuscript. FMI and PM are the guarantors. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.
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The protocol was approved by the ethics committee of the National Institute for Infectious Diseases Lazzaro Spallanzani. The protocol was also submitted and approved by the Local Ethical Committees.
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Informed consent for each patient participation was collected from clinical centres.
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Menniti-Ippolito, F., Mele, A., Da Cas, R. et al. Safety and efficacy of COVID-19 vaccines in patients on dialysis: a multicentre cohort study in Italy. J Nephrol 36, 2013–2022 (2023). https://doi.org/10.1007/s40620-023-01708-7
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DOI: https://doi.org/10.1007/s40620-023-01708-7