Safety and immediate humoral response of COVID-19 vaccines in chronic kidney disease patients: the SENCOVAC study
Borja Quiroga, María José Soler, Alberto Ortíz, Shaira Martínez Vaquera, Carlos Jesús Jarava Mantecón, Gustavo Useche, Marı́a Gabriela Márquez, Manuel Torralba Carnerero, Maria Teresa Jaldo Rodríguez, Patricia Muñoz Ramos, Juan Carlos Ruiz, Néstor Toapanta, Carolina Gracia-Iguacel, María Cinta Aguilar Cervera, Noelia Balibrea Lara, Alba Leyva, José Antonio Muñoz Rojas, Ron T. Gansevoort, Patricia de Sequera, SENCOVAC Collaborative Network, José Luis Pizarro León, Manuel Antonio Martínez García, Benaldina García Jiménez, Virginia Olinda Gómez Pérez, Juan de Dios Ramiro Moya, Diana López Espinosa, Alejandro Jiménez Herrador, Manuel Navarro Zurita, Leonardo Díaz Álvarez, Álvaro González Martínez, Sandra Báez Arroyo, Raquel Reina Fernández, Marlyn Janella Suárez Vargas, Rocío Calurano Casero, Amparo Bernat García, Ana Beatriz Muñoz Díaz, Carmen Santamaría de Miguel, Ángel Palacios, Brenda Henningsmeyer, Esther Orero Calve, José Lacueva Moya, Yurika Sato, Marta Serra Marín, Carolina Lancho Novillo, Pedro Luis Quirós Ganga, Fernando Vallejo Carrión, Antonio Luis García Herrera, Irene Torres, Pablo Delgado Conde, Georgina Alfaro, Olga Halauko, Fouad El Rifai, Ana Dolores Martínez, Rafael Lucena Valverde, Marta Puerta Carretero, Mayra Ortega Díaz, Daniel Gaitán Tocora, Esther Rodriguez Suárez, Alfredo José Sáenz Santolaya, Sandra Castellano Gash, Lara Ruíz Martínez, Yohana Gil Giraldo, Martín Giorgi, Carmen Sánchez, Ana Sánchez Horrillo, Pablo Ruano Suárez, Antonio Fernández Perpén, Andrés Fernández-Ramos, Laura Salanova Villanueva, Alejandra Cortiñas, Pablo A Díez Arias, Alicia Cabrera Cárdenas, Antonio de Santos, Almudena Hernández Núñez, Guillermina Barril, Raquel Repollet, Rosalía Valero, Celestino Piñera Haces, María Kislikova, Emilio Rodrigo, Francesc Moreso, Emilio González‐Parra, Catalina Martín-Cleary, Jinny Sánchez-Rodríguez y Ana Ramos-Verde, María Teresa Rodrigo De Tomas, Beatriz Azcue Prieto, Carmen Toyos Y José Molina Del Rio, Adriana Restrepo Acosta, Amagoia Celayeta Zamacona, Francisco Contreras, Dioné González Ferri, Eduardo Muñoz de Bustillo Llorente, Nuria Garcı́a-Fernández, Paloma Leticia Martin Moreno, Noelia Ania González, Ana Sabalza Ortiz, María Nieves Bastida Iñarrea, Ana M. Tato Ribera, Eduardo Gallego Valcarce, Enrique Gruss Vergara
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.