Abstract
Background
Chronic kidney disease (CKD) patients are at high-risk for severe Covid-19. The multicentric, observational and prospective SENCOVAC study aims to describe the humoral response and safety of 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, 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 analyzed.
Results
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 to KT (OR 20.56, p = 0.001) and to BNT162b2 vaccine (OR 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.
Keywords: antibodies, COVID-19, humoral response, SARS-CoV-2, vaccine
Contributor Information
Borja Quiroga, Nephrology Department, Hospital Universitario de la Princesa, Madrid, Spain.
María José Soler, Nephrology Department, Vall d'Hebrón University Hospital, Barcelona, Spain.
Alberto Ortiz, 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.
Shaira Martínez Vaquera, Diaverum, Spain.
Carlos Jesús Jarava Mantecón, Diaverum, Spain.
Gustavo Useche, Diaverum, Spain.
María Gabriela Sánchez Márquez, Nephrology Department, Hospital Universitario Puerto Real, Cádiz, Spain.
Manuel Carnerero, Diaverum, Spain.
María Teresa Jaldo Rodríguez, Nephrology Department, Infanta Leonor University Hospital, Madrid, Spain.
Patricia Muñoz Ramos, Nephrology Department, Hospital Universitario de la Princesa, Madrid, Spain.
Juan Carlos Ruiz San Millán, Nephrology Department, Hospital Universitario Marqués de Valdecilla, Santander, Spain.
Nestor Toapanta, Nephrology Department, Vall d'Hebrón University Hospital, Barcelona, Spain.
Carolina Gracia-Iguacel, 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.
María Cinta Aguilar Cervera, Nephrology Department, Hospital Universitario de Donostia, San Sebastián, Spain.
Noelia Balibrea Lara, Nephrology Department, Hospital General Universitario de Alicante, Alicante, Spain.
Alba Leyva, R&D Department, VIRCELL SL, Granada, Spain.
José Rojas, R&D Department, VIRCELL SL, Granada, Spain.
Ron T Gansevoort, Dept. Internal Medicine, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Patricia de Sequera, Nephrology Department, Infanta Leonor University Hospital, Madrid, Spain.
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 E l 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 Núñez, Guillermina Barril Cuadrado, Raquel Repollet, Rosalía Valero San Cecilio, Celestino Piñera Haces, María Kislikova, Emilio Rodrigo, Francesc Moreso, Emilio Gonzalez-Parra, Catalina Martin-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 Javier Pérez Contreras, Dioné González Ferri, Eduardo Muñoz de Bustillo Llorente, Nuria García-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, María Rosario Llópez Carratalá, Leyre María Martin Rodríguez, Marisa Serrano Salazar, Begoña Bravo Prieto, José María Portolés Pérez, Ma Isabel Jimeno Martin, Saioa Bilbao Ortega, Ma Isabel Gallardo Ruiz, Ainhoa Hernando Rubio, Paula Garcia Ledesma, Alvaro Goyoaga Alvarez, Natalia Blanco Castro, Augusto Quiroz Morales, Ignacio Manzur Cavalotti, Itziar Navarro Zorita, Sol Otero López, Sara Outon González, Carlos Soto Montañez, Esteban Poch López de Briñas, David Cucchiari, José Broseta Monzo, Auxiliadora Mazuecos, Juan Manuel Cazorla, Teresa García, Carlos Narváez, Cristhian Orellana, Nicolás Macías Carmona, David Arroyo Rueda, María Luisa Rodríguez Ferrero, Almudena Vega Martínez, Soraya Abad Estébanez, Jesús Calviño Varela, Alba García Enríquez, Carmen Cobelo Casas, Pablo Otero Alonso, Lourdes González Tabares, Laura Muñiz Pacios, Lina León Machado, Isabel Berdud Godoy, Esther Torres Aguilera, Rolando Tello Alea, Margie Soledad Del Rosario Saldaña, Maria Antònia Munar Vila, Soledad Pizarro Sánchez, Simona Alexandru, Laura García Puente Suarez, Saul Pampa Saico, Marisol Poma Tapia, Virginia Lopez De La Manzanara Perez, Marta Calvo Arevalo, Jose Antonio Herrero Calvo, Auxiliadora Bajo Rubio, Gloria Del Peso Gilsanz, Marta Ossorio Gonzalez, Rafael Sánchez Villanueva, Maria Ovidia Lopez Oliva, Antonio Gil Paraiso, Marta Sanz Sainz, Maria Laura Salvetti, María Cufi Valmajor, Montserrat Picazo Sánchez, Miriam Llado Barragán, Laia Reixach Aunatell, Beatriz Escamilla Cabrera, Aurelio Pastor Rodríguez Hernández, María Sagrario García Rebollo, Juana Margarita Rufino Hernández, José María Lamas Barreiro, Sofía Zarraga Larrondo, Joaquín Manrique, Alejandra Yugueros González, Antonio Marín Franco, Lucía Sobrino Díaz, Pilar Sánchez Pérez, Adelaida Morales Umpierrez, Esther Hurtado Ruiz, Aránzazu Márquez Corbella, Katia Toledo Perdomo, Yasmina Martín Martín, Blanca Villacorta Linaza, Antonio Galán Serrano, Patricia Tomás Simó, Humberto Daniel Rojas Mancilla, Marta Poves Gómez, Juan Villaro Gumpert, Secundino Cigarrán Guldris, Rosa Sánchez Hernández, Enriqueta González Rodríguez, Gabriel de Arriba de la Fuente, Rosa María Ruiz-Calero Cendrero, José María Baltar Martín, José Ignacio Minguela Pesquera, Pablo Justo Ávila, and Eva Cotilla de la Rosa
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