Safety and immediate humoral response of COVID-19 vaccines in chronic kidney disease patients: the SENCOVAC study
Authors: Quiroga Borja , Soler María José , Ortiz Alberto , Martínez Vaquera Shaira , Jarava Mantecón Carlos Jesús , Useche Gustavo , Sánchez Márquez María Gabriela , Carnerero Manuel , Jaldo Rodríguez María Teresa , Muñoz Ramos Patricia , Ruiz San Millán Juan Carlos , Toapanta Nestor , Gracia-Iguacel Carolina , Aguilar Cervera María Cinta , Balibrea Lara Noelia , Leyva Alba , Rojas José , Gansevoort Ron T , de Sequera Patricia ,   SENCOVAC Collaborative Network, 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 
Published: October 2021

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 &lt; 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.