Safety and immediate humoral response of COVID-19 vaccines in chronic kidney disease patients: the SENCOVAC study

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.

COVID-19 in dialysis: clinical impact, immune response, prevention, and treatment

“…It is tempting to speculate that markers of immunosenescence may be better predictors of the immune response than chronological age per se. Antibody titers were numerically higher in peritoneal dialysis than in hemodialysis patients in some [72][73][74] , but not all studies 75,76 .…”

Short and mid‐term SARS‐CoV‐2 antibody response after inactivated COVID‐19 vaccine in hemodialysis and kidney transplant patients

“… 3 , 4 So far, messenger RNA (mRNA)‐based COVID‐19 vaccines have proven to be the most protective vaccine type against COVID‐19 disease in the normal population and in different chronic kidney diseases (CKDs). 3 , 5 , 6 , 7 CKD and kidney transplantation are important independent risk factors for severe COVID‐19 disease. 8 , 9 , 10 In addition, COVID‐19 disease‐related mortality rates are higher in patients receiving renal replacement therapy (RRT) than in the normal population.…”

“…However, the efficacy of COVID‐19 vaccines in immunocompromised kidney transplant patients was found to be significantly lower than in other populations. 5 , 6 At the beginning of the COVID‐19 pandemic, it was not understood how effective the vaccines were in these patient groups, as the phase III studies against COVID‐19 did not include CKD, dialysis, or kidney recipients and focused only on normal individuals. However, in studies conducted after the administration of vaccines over time, it has been found that antibody responses are weaker in uremic and immunosuppressive patients.…”

“…With these measures, it has been clearly demonstrated that the COVID‐19 disease can be controlled after the emergence of different effective and safe vaccines in the normal population 3,4 . So far, messenger RNA (mRNA)‐based COVID‐19 vaccines have proven to be the most protective vaccine type against COVID‐19 disease in the normal population and in different chronic kidney diseases (CKDs) 3,5–7 . CKD and kidney transplantation are important independent risk factors for severe COVID‐19 disease 8–10 .…”

The last pre-pandemic European Renal Association Registry report: age at start of kidney replacement therapy in Europe

“…Transport to and from haemodialysis (HD) was a key risk factor for COVID-19 in HD patients early in the pandemic [ 5 ]. Additionally, patients with CKD, and especially kidney transplant recipients, display an accelerated loss of anti-severe acute respiratory syndrome coronavirus 2 antibodies following infection as well as suboptimal response to vaccines [ 6 , 7 ]. Thus the COVID-19 pandemic is expected to have a major impact on KRT incidence and prevalence as well as on incident and prevalent KRT age in the ERA Registry Annual Report from 2020 onwards.…”