ABSTRACT
BACKGROUND: Hemodialysis (HD) patients have a high prevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and mortality, but they may have a weak response to coronavirus disease 2019 (COVID-19) vaccines. OBJECTIVES: This study aimed to evaluate factors predictive of humoral response in HD patients vaccinated against SARS-CoV-2 infection. MATERIAL AND METHODS: This is a 2-center observational study including HD patients who received the BNT162b2 mRNA vaccine followed by serological measurements 20 days and 4 weeks after the 1st and 2nd dose, respectively. Healthy controls were included. Anti-spike antibody was measured using the chemiluminescent immunoassay (CLIA) method. The quantile regression analysis was performed to assess factors associated with anti-spike antibody titers. RESULTS: Seventy-two HD patients and 22 healthy controls were included. Mean age of dialysis patients and controls was 72.5 ±11.5 years and 45.7 ±17.4 years, respectively. In the HD group, median levels of anti-spike antibody were 3 (interquartile range (IQR): 0.5-26) UI/mL and 391 (IQR: 55-1642) UI/mL after the 1st and 2nd dose, respectively, with response rates of 62.5% and 96.7%. The median level of the anti-spike antibody after the 1st dose in previously infected patients was 8571 (IQR: 2586-19147) UI/mL. There was a significant correlation between anti-spike antibody levels after the 2nd dose and age and anti-hepatitis B surface (HBs) antibody and serum albumin levels (Spearman's rho: r = -0.289, p < 0.001; r = 0.357, p = 0.027; r = 0.317; p = 0.026, respectively). The regression analysis showed a significant association of previous infection and anti-Hbs antibody level with anti-spike antibody level after the 1st dose of vaccine (p < 0.001). After a 5-month follow-up, 2 vaccinated patients contracted COVID-19. CONCLUSIONS: This study showed a response rate of 96.7% to 2 doses of BNT162b2 mRNA vaccine in HD patients and 100% to a single dose in previously infected patients. The level of anti-spike antibody can be predicted by age, anti-Hbs antibodies, serum albumin, and previous infection. Despite the immunization of patients, preventive measures should be maintained in all dialysis units.
Subject(s)
COVID-19 Vaccines , COVID-19 , Aged , Aged, 80 and over , Antibodies, Viral , BNT162 Vaccine , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Hepatitis B Antibodies , Humans , Middle Aged , Renal Dialysis/adverse effects , SARS-CoV-2 , Serum Albumin , Vaccination , Vaccines, Synthetic , mRNA VaccinesABSTRACT
BACKGROUND: Treatment with erythropoietin is well established for anemia in chronic kidney disease patients but not well studied in acute kidney injury. METHODS: This is a multicenter, randomized, pragmatic controlled clinical trial. It included 134 hospitalized patients with anemia defined as hemoglobin < 11 g/dL and acute kidney injury defined as an increase of serum creatinine of ≥ 0.3 mg/dL within 48 h or 1.5 times baseline. One arm received recombinant human erythropoietin 4000 UI subcutaneously every other day (intervention; n = 67) and the second received standard of care (control; n = 67) during the hospitalization until discharge or death. The primary outcome was the need for transfusion; secondary outcomes were death, renal recovery, need for dialysis. RESULTS: There was no statistically significant difference in transfusion need (RR = 1.05, 95%CI 0.65,1.68; p = 0.855), in renal recovery full or partial (RR = 0.96, 95%CI 0.81,1.15; p = 0.671), in need for dialysis (RR = 11.00, 95%CI 0.62, 195.08; p = 0.102) or in death (RR = 1.43, 95%CI 0.58,3.53; p = 0.440) between the erythropoietin and the control group. CONCLUSIONS: Erythropoietin treatment had no impact on transfusions, renal recovery or mortality in acute kidney injury patients with anemia. The trial was registered on ClinicalTrials.gov (NCT03401710, 17/01/2018).
