Safety and immediate humoral response of COVID-19 vaccines in chronic kidney disease patients: the SENCOVAC study
Author:
Quiroga Borja1ORCID, Soler María José2ORCID, Ortiz Alberto3ORCID, Martínez Vaquera Shaira4, Jarava Mantecón Carlos Jesús4, Useche Gustavo4, Sánchez Márquez María Gabriela5, Carnerero Manuel4, Jaldo Rodríguez María Teresa6, Muñoz Ramos Patricia1, Ruiz San Millán Juan Carlos7, Toapanta Nestor2ORCID, Gracia-Iguacel Carolina3, Aguilar Cervera María Cinta8, Balibrea Lara Noelia9, Leyva Alba10, Rojas José10, Gansevoort Ron T11, de Sequera Patricia6, León José Luis Pizarro, García Manuel Antonio Martínez, Jiménez Benaldina García, Pérez Virginia Olinda Gómez, Moya Juan de Dios Ramiro, Espinosa Diana López, Herrador Alejandro Jiménez, Zurita Manuel Navarro, Álvarez Leonardo Díaz, Martínez Álvaro González, Arroyo Sandra Báez, Fernández Raquel Reina, Vargas Marlyn Janella Suárez, Casero Rocío Calurano, García Amparo Bernat, Díaz Ana Beatriz Muñoz, de Miguel Carmen Santamaría, Palacios Ángel, Henningsmeyer Brenda, Calve Esther Orero, Moya José Lacueva, Sato Yurika, Marín Marta Serra, Novillo Carolina Lancho, Ganga Pedro Luis Quirós, Carrión Fernando Vallejo, Herrera Antonio Luis García, Torres Irene, Conde Pablo Delgado, Alfaro Georgina, Halauko Olga, El Rifai Fouad, Martínez Ana Dolores, Valverde Rafael Lucena, Carretero Marta Puerta, Díaz Mayra Ortega, Tocora Daniel Gaitán, Suárez Esther Rodriguez, Santolaya Alfredo José Sáenz, Gash Sandra Castellano, Martínez Lara Ruíz, Giraldo Yohana Gil, Giorgi Martín, Sánchez Carmen, Horrillo Ana Sánchez, Suárez Pablo Ruano, Perpén Antonio Fernández, Ramos Andrés Fernández, Villanueva Laura Salanova, Cortiñas Alejandra, Arias Pablo A Díez, Cárdenas Alicia Cabrera, de Santos Antonio, Núñez Almudena, Cuadrado Guillermina Barril, Repollet Raquel, Cecilio Rosalía Valero San, Haces Celestino Piñera, Kislikova María, Rodrigo Emilio, Moreso Francesc, Gonzalez-Parra Emilio, Martin-Cleary Catalina, Ramos-Verde Jinny Sánchez-Rodríguez y Ana, De Tomas María Teresa Rodrigo, Prieto Beatriz Azcue, Del Rio Carmen Toyos Y José Molina, Acosta Adriana Restrepo, Zamacona Amagoia Celayeta, Contreras Francisco Javier Pérez, Ferri Dioné González, Llorente Eduardo Muñoz de Bustillo, García-Fernández Nuria, Moreno Paloma Leticia Martin, González Noelia Ania, Ortiz Ana Sabalza, Iñarrea María Nieves Bastida, Ribera Ana M Tato, Valcarce Eduardo Gallego, Vergara Enrique Gruss, Carratalá María Rosario Llópez, Rodríguez Leyre María Martin, Salazar Marisa Serrano, Prieto Begoña Bravo, Pérez José María Portolés, Martin Ma Isabel Jimeno, Ortega Saioa Bilbao, Ruiz Ma Isabel Gallardo, Rubio Ainhoa Hernando, Ledesma Paula Garcia, Alvarez Alvaro Goyoaga, Castro Natalia Blanco, Morales Augusto Quiroz, Cavalotti Ignacio Manzur, Zorita Itziar Navarro, López Sol Otero, González Sara Outon, Montañez Carlos Soto, de Briñas Esteban Poch López, Cucchiari David, Monzo José Broseta, Mazuecos Auxiliadora, Cazorla Juan Manuel, García Teresa, Narváez Carlos, Orellana Cristhian, Carmona Nicolás Macías, Rueda David Arroyo, Ferrero María Luisa Rodríguez, Martínez Almudena Vega, Estébanez Soraya Abad, Varela Jesús Calviño, Enríquez Alba García, Casas Carmen Cobelo, Alonso Pablo Otero, Tabares Lourdes González, Pacios Laura Muñiz, Machado Lina León, Godoy Isabel Berdud, Aguilera Esther Torres, Alea Rolando Tello, Saldaña Margie Soledad Del Rosario, Vila Maria Antònia Munar, Sánchez Soledad Pizarro, Alexandru Simona, Suarez Laura García Puente, Saico Saul Pampa, Tapia Marisol Poma, Perez Virginia Lopez De La Manzanara, Arevalo Marta Calvo, Calvo Jose Antonio Herrero, Rubio Auxiliadora Bajo, Gilsanz Gloria Del Peso, Gonzalez Marta Ossorio, Villanueva Rafael Sánchez, Oliva Maria Ovidia Lopez, Paraiso Antonio Gil, Sainz Marta Sanz, Salvetti Maria Laura, Valmajor María Cufi, Sánchez Montserrat Picazo, Barragán Miriam Llado, Aunatell Laia Reixach, Cabrera Beatriz Escamilla, Hernández Aurelio Pastor Rodríguez, Rebollo María Sagrario García, Hernández Juana Margarita Rufino, Barreiro José María Lamas, Larrondo Sofía Zarraga, Manrique Joaquín, González Alejandra Yugueros, Franco Antonio Marín, Díaz Lucía Sobrino, Pérez Pilar Sánchez, Umpierrez Adelaida Morales, Ruiz Esther Hurtado, Corbella Aránzazu Márquez, Perdomo Katia Toledo, Martín Yasmina Martín, Linaza Blanca Villacorta, Serrano Antonio Galán, Simó Patricia Tomás, Mancilla Humberto Daniel Rojas, Gómez Marta Poves, Gumpert Juan Villaro, Guldris Secundino Cigarrán, Hernández Rosa Sánchez, Rodríguez Enriqueta González, de la Fuente Gabriel de Arriba, Cendrero Rosa María Ruiz-Calero, Martín José María Baltar, Pesquera José Ignacio Minguela, Ávila Pablo Justo, de la Rosa Eva Cotilla,
Affiliation:
1. Nephrology Department, Hospital Universitario de la Princesa, Madrid, Spain 2. Nephrology Department, Vall d'Hebrón University Hospital, Barcelona, Spain 3. IIS-Fundación Jimenez Diaz, School of Medicine, Universidad Autónoma de Madrid, Fundación Renal Iñigo Alvarez de Toledo-IRSIN, REDinREN, Instituto de Investigación Carlos III, Madrid, Spain 4. Diaverum, Spain 5. Nephrology Department, Hospital Universitario Puerto Real, Cádiz, Spain 6. Nephrology Department, Infanta Leonor University Hospital, Madrid, Spain 7. Nephrology Department, Hospital Universitario Marqués de Valdecilla, Santander, Spain 8. Nephrology Department, Hospital Universitario de Donostia, San Sebastián, Spain 9. Nephrology Department, Hospital General Universitario de Alicante, Alicante, Spain 10. R&D Department, Vircell S.L., Granada, Spain 11. Department of Internal Medicine, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands
Abstract
ABSTRACT
Background
Chronic kidney disease (CKD) patients are at high-risk for severe coronavirus disease 2019 (COVID-19). The multicentric, observational and prospective SENCOVAC study aims to describe the humoral response and safety of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines in CKD patients. Safety and immediate humoral response results are reported here.
Methods
Four cohorts of patients were included: kidney transplant (KT) recipients, and haemodialysis (HD), peritoneal dialysis (PD) and non-dialysis CKD patients from 50 Spanish centres. Adverse events after vaccine doses were recorded. At baseline and on Day 28 after the last vaccine dose, anti-Spike antibodies were measured and compared between cohorts. Factors associated with development of anti-Spike antibodies were analysed.
Results
A total of 1746 participants were recruited: 1116 HD, 171 PD, 176 non-dialysis CKD patients and 283 KT recipients. Most patients (98%) received mRNA vaccines. At least one vaccine reaction developed after the first dose in 763 (53.5%) and after the second dose in 741 (54.5%) of patients. Anti-Spike antibodies were measured in the first 301 patients. At 28 days, 95% of patients had developed antibodies: 79% of KT, 98% of HD, 99% of PD and 100% of non-dialysis CKD patients (P < 0.001). In a multivariate adjusted analysis, absence of an antibody response was independently associated with KT (odds ratio 20.56, P = 0.001) and with BNT162b2 vaccine (odds ratio 6.03, P = 0.023).
Conclusion
The rate of anti-Spike antibody development after vaccination in KT patients was low but in other CKD patients it approached 100%, suggesting that KT patients require persistent isolation measures and booster doses of a COVID-19 vaccine. Potential differences between COVID-19 vaccines should be explored in prospective controlled studies.
Funder
Fresenius Medical Care Diaverum Vifor Pharma Vircell Fundación Renal Iñigo Álvarez de Toledo
Publisher
Oxford University Press (OUP)
Subject
Transplantation,Nephrology
Cited by
45 articles.
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