Abstract
Background: Determining the humoral immunogenicity of tozinameran (BNT162b2) in patients requiring chronic renal replacement therapy, and its impact on COVID-19 morbidity several months after vaccination, may guide risk assessment and changes in vaccination policy.
Methods: In a prospective post-vaccination cohort study with up to 5 months follow-up we studied outpatient dialysis and kidney transplant patients and respective healthcare teams. Outcomes were anti S1/S2 antibody responses to vaccine or infection, and infection rate during follow-up.
Results: One hundred seventy-five dialysis patients (40% women, 65 ± 15 years), 252 kidney transplant patients (33% women, 54 ± 14 years) and 71 controls (65% women, 44 ± 14 years) were followed. Three months or longer after vaccination we detected anti S1/S2 IgG antibodies in 79% of dialysis patients, 42% of transplant recipients and 100% of controls, whereas respective rates after infection were 94%, 69% and 100%. Predictors of non-response were older age, diabetes, history of cancer, lower lymphocyte count and lower vitamin-D levels. Factors associated with lower antibody levels in dialysis patients were modality (hemodialysis vs peritoneal) and high serum ferritin levels. In transplant patients, hypertension and higher calcineurin or mTOR inhibitor drug levels were linked with lower antibody response. Vaccination was associated with fewer subsequent infections (HR 0.23, p < 0.05). Moreover, higher antibody levels (particularly above 59 AU/ml) were associated with fewer events, with a HR 0.41 for each unit increased in log 10 titer (p < 0.05).
Conclusions: Dialysis patients, and more strikingly kidney transplant recipients, mounted reduced antibody response to COVID-19 mRNA vaccination. Lesser humoral response was associated with more infections. Measures to identify and protect non-responsive patients are required.
Keywords: COVID-19; End-stage renal disease; Hemodialysis; Kidney transplantation; Peritoneal dialysis; Vaccines; Viral infections.
【저자키워드】 COVID-19, Vaccines, Viral infections., Kidney transplantation, Hemodialysis, End-stage renal disease, Peritoneal dialysis, 【초록키워드】 mRNA vaccination, Vaccine, vaccination, antibody, Cancer, Antibody Response, Infection, risk, ferritin, diabetes, hypertension, viral infections, dialysis, Risk assessment, cohort study, BNT162b2, Lymphocyte count, lymphocyte, infections, Hemodialysis, IgG antibody, healthcare, morbidity, Patient, Older age, Control, End-stage renal disease, Follow-up, infection rate, women, Peritoneal dialysis, renal disease, patients, kidney transplant, renal replacement therapy, kidney transplant recipients, mTOR, humoral, replacement therapy, COVID-19 mRNA Vaccination, Serum ferritin, Factor, S1/S2, measure, renal, modality, recipient, calcineurin, humoral immunogenicity, Subsequent infection, mTOR inhibitor, controls, PROTECT, log, identify, required, events, reduced, changes in, Determining, drug level, mounted, 【제목키워드】 mRNA vaccine, Impact, Follow-up, kidney transplant,