Safety and immediate humoral response of COVID-19 vaccines in chronic kidney disease patients: the SENCOVAC study.
COVID-19
SARS-CoV-2
antibodies
humoral response
vaccine
Journal
Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association
ISSN: 1460-2385
Titre abrégé: Nephrol Dial Transplant
Pays: England
ID NLM: 8706402
Informations de publication
Date de publication:
22 09 2022
22 09 2022
Historique:
received:
11
09
2021
pubmed:
18
11
2021
medline:
24
9
2022
entrez:
17
11
2021
Statut:
ppublish
Résumé
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. 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. 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). 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.
Sections du résumé
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.
Identifiants
pubmed: 34788858
pii: 6426121
doi: 10.1093/ndt/gfab313
pmc: PMC8767866
doi:
Substances chimiques
Antibodies, Viral
0
COVID-19 Vaccines
0
BNT162 Vaccine
N38TVC63NU
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1868-1878Investigateurs
José Luis Pizarro León
(JLP)
Manuel Antonio Martínez García
(MAM)
Benaldina García Jiménez
(BG)
Virginia Olinda Gómez Pérez
(VOG)
Juan de Dios Ramiro Moya
(JDR)
Diana López Espinosa
(DL)
Alejandro Jiménez Herrador
(AJ)
Manuel Navarro Zurita
(MN)
Leonardo Díaz Álvarez
(LD)
Álvaro González Martínez
(ÁG)
Sandra Báez Arroyo
(SB)
Raquel Reina Fernández
(RR)
Marlyn Janella Suárez Vargas
(MJS)
Rocío Calurano Casero
(RC)
Amparo Bernat García
(AB)
Ana Beatriz Muñoz Díaz
(ABM)
Carmen Santamaría de Miguel
(CS)
Ángel Palacios
(Á)
Brenda Henningsmeyer
(B)
Esther Orero Calve
(EO)
José Lacueva Moya
(JL)
Yurika Sato
(Y)
Marta Serra Marín
(MS)
Carolina Lancho Novillo
(CL)
Pedro Luis Quirós Ganga
(PLQ)
Fernando Vallejo Carrión
(FV)
Antonio Luis García Herrera
(ALG)
Irene Torres
(I)
Pablo Delgado Conde
(PD)
Georgina Alfaro
(G)
Olga Halauko
(O)
Fouad El Rifai
(F)
Ana Dolores Martínez
(AD)
Rafael Lucena Valverde
(RL)
Marta Puerta Carretero
(MP)
Mayra Ortega Díaz
(MO)
Daniel Gaitán Tocora
(DG)
Esther Rodriguez Suárez
(ER)
Alfredo José Sáenz Santolaya
(AJS)
Sandra Castellano Gash
(SC)
Lara Ruíz Martínez
(LR)
Yohana Gil Giraldo
(YG)
Martín Giorgi
(M)
Carmen Sánchez
(C)
Ana Sánchez Horrillo
(AS)
Pablo Ruano Suárez
(PR)
Antonio Fernández Perpén
(AF)
Andrés Fernández Ramos
(AF)
Laura Salanova Villanueva
(LS)
Alejandra Cortiñas
(A)
Pablo A Díez Arias
(PAD)
Alicia Cabrera Cárdenas
(AC)
Antonio de Santos
(A)
Almudena Núñez
(A)
Guillermina Barril Cuadrado
(GB)
Raquel Repollet
(R)
Rosalía Valero San Cecilio
(RVS)
Celestino Piñera Haces
(CP)
María Kislikova
(M)
Emilio Rodrigo
(E)
Francesc Moreso
(F)
Emilio Gonzalez-Parra
(E)
Catalina Martin-Cleary
(C)
Jinny Sánchez-Rodríguez Y Ana Ramos-Verde
(JSYA)
María Teresa Rodrigo De Tomas
(MTR)
Beatriz Azcue Prieto
(BA)
Carmen Toyos Y José Molina Del Rio
(CTYJM)
Adriana Restrepo Acosta
(AR)
Amagoia Celayeta Zamacona
(AC)
Francisco Javier Pérez Contreras
(FJP)
Dioné González Ferri
(DG)
Eduardo Muñoz de Bustillo Llorente
(EMB)
Nuria García-Fernández
(N)
Paloma Leticia Martin Moreno
(PLM)
Noelia Ania González
(NA)
Ana Sabalza Ortiz
(AS)
María Nieves Bastida Iñarrea
(MNB)
Ana M Tato Ribera
(AMT)
Eduardo Gallego Valcarce
(EG)
Enrique Gruss Vergara
(EG)
María Rosario Llópez Carratalá
(MRL)
Leyre María Martin Rodríguez
(LMM)
Marisa Serrano Salazar
(MS)
Begoña Bravo Prieto
(BB)
José María Portolés Pérez
(JMP)
Ma Isabel Jimeno Martin
(MIJ)
Saioa Bilbao Ortega
(SB)
Ma Isabel Gallardo Ruiz
(MIG)
Ainhoa Hernando Rubio
(AH)
Paula Garcia Ledesma
(PG)
Alvaro Goyoaga Alvarez
(AG)
Natalia Blanco Castro
(NB)
Augusto Quiroz Morales
(AQ)
Ignacio Manzur Cavalotti
(IM)
Itziar Navarro Zorita
(IN)
Sol Otero López
(SO)
Sara Outon González
(SO)
Carlos Soto Montañez
(CS)
Esteban Poch López de Briñas
(EPL)
David Cucchiari
(D)
José Broseta Monzo
(JB)
Auxiliadora Mazuecos
(A)
Juan Manuel Cazorla
(JM)
Teresa García
(T)
Carlos Narváez
(C)
Cristhian Orellana
(C)
Nicolás Macías Carmona
(NM)
David Arroyo Rueda
(DA)
María Luisa Rodríguez Ferrero
(MLR)
Almudena Vega Martínez
(AV)
Soraya Abad Estébanez
(SA)
Jesús Calviño Varela
(JC)
Alba García Enríquez
(AG)
Carmen Cobelo Casas
(CC)
Pablo Otero Alonso
(PO)
Lourdes González Tabares
(LG)
Laura Muñiz Pacios
(LM)
Lina León Machado
(LL)
Isabel Berdud Godoy
(IB)
Esther Torres Aguilera
(ET)
Rolando Tello Alea
(RT)
Margie Soledad Del Rosario Saldaña
(MSDR)
Maria Antònia Munar Vila
(MAM)
Soledad Pizarro Sánchez
(SP)
Simona Alexandru
(S)
Laura García Puente Suarez
(LGP)
Saul Pampa Saico
(SP)
Marisol Poma Tapia
(MP)
Virginia Lopez De La Manzanara Perez
(VLM)
Marta Calvo Arevalo
(MC)
Jose Antonio Herrero Calvo
(JAH)
Auxiliadora Bajo Rubio
(AB)
Gloria Del Peso Gilsanz
(GDP)
Marta Ossorio Gonzalez
(MO)
Rafael Sánchez Villanueva
(RS)
Maria Ovidia Lopez Oliva
(MOL)
Antonio Gil Paraiso
(AG)
Marta Sanz Sainz
(MS)
Maria Laura Salvetti
(ML)
María Cufi Valmajor
(MC)
Montserrat Picazo Sánchez
(MP)
Miriam Llado Barragán
(ML)
Laia Reixach Aunatell
(LR)
Beatriz Escamilla Cabrera
(BE)
Aurelio Pastor Rodríguez Hernández
(APR)
María Sagrario García Rebollo
(MSG)
Juana Margarita Rufino Hernández
(JMR)
José María Lamas Barreiro
(JML)
Sofía Zarraga Larrondo
(SZ)
Joaquín Manrique
(J)
Alejandra Yugueros González
(AY)
Antonio Marín Franco
(AM)
Lucía Sobrino Díaz
(LS)
Pilar Sánchez Pérez
(PS)
Adelaida Morales Umpierrez
(AM)
Esther Hurtado Ruiz
(EH)
Aránzazu Márquez Corbella
(AM)
Katia Toledo Perdomo
(KT)
Yasmina Martín Martín
(YM)
Blanca Villacorta Linaza
(BV)
Antonio Galán Serrano
(AG)
Patricia Tomás Simó
(PT)
Humberto Daniel Rojas Mancilla
(HDR)
Marta Poves Gómez
(MP)
Juan Villaro Gumpert
(JV)
Secundino Cigarrán Guldris
(SC)
Rosa Sánchez Hernández
(RS)
Enriqueta González Rodríguez
(EG)
Gabriel de Arriba de la Fuente
(GA)
Rosa María Ruiz-Calero Cendrero
(RMR)
José María Baltar Martín
(JMB)
José Ignacio Minguela Pesquera
(JIM)
Pablo Justo Ávila
(PJ)
Eva Cotilla de la Rosa
(EC)
Informations de copyright
© The Author(s) 2021. Published by Oxford University Press on behalf of the ERA.