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.
Keywords: COVID-19; SARS-CoV-2; antibodies; humoral response; vaccine.
【저자키워드】 COVID-19, antibodies, SARS-CoV-2, Vaccine, Humoral response, 【초록키워드】 Vaccine, BNT162b2 vaccine, coronavirus, COVID-19 vaccine, vaccination, Safety, antibody, Antibody Response, mRNA vaccines, vaccine dose, Patient, Adjusted analysis, Isolation, Haemodialysis, Kidney disease, Peritoneal dialysis, booster dose, patients, kidney transplant, Odds ratio, CKD, humoral, chronic, acute respiratory syndrome, Factor, Adverse, recipients, severe coronavirus disease, second dose, first dose, measure, cohorts, participant, Spanish, event, reported, Day, Most patient, analysed, absence, were measured, were recorded, baseline, cohorts of patient, Potential difference, 【제목키워드】 COVID-19 vaccine, Safety, Chronic kidney disease, humoral,