Table 1.
Clinical characterization of HD patients classified as non-responders or responders according to anti-spike IgG levels at t2.
| Characteristics | Non-responders | Responders |
|---|---|---|
| (N = 13) | (N = 130) | |
| Sex, men, n (%) | 9 (69.2) | 88 (67.7) |
| Age (years), median [IQR] | 86 [74–90]* | 71 [59–79]* |
| Body Weight (Kg), median [IQR] | 69 [56–74] | 72 [63–83] |
| BMI (kg/m2), median [IQR] | 24.7 [21.9–25.7] | 26 [23–30] |
| Dialysis duration (months), median [IQR] | 46 [30–116] | 46 [20–113] |
| Kt/v, median [IQR] | 1.8 [1.7–2.0] | 1.7 [1.5–1.9] |
| Laboratory parameters | ||
| Hemoglobin (g/dL), median [IQR] | 11.7 [11.1–12.7] | 11.1 [10.4–11.8] |
| Serum albumin (g/dL), median [IQR] | 4.0[3.6–4.1] | 4.0 [3.8–4.3] |
| Ferritin (ng/mL), median [IQR] | 348 [238–520] | 368 [230–527] |
| nPCR (g/kg/day), median [IQR] | 0.94 [0.90–1.23] | 1.11 [0.95–1.22] |
| CRP (mg/dL), median [IQR] | 0.55 [0.20–2.81] | 0.48 [0.15–1.25] |
| 25(OH)D3 (ng/mL), median [IQR] | 35.0 [29.9–48.6] | 35.3 [26.0–45.0] |
| Comorbidities | ||
| Age adjusted Charlson score, median [IQR] | 8.0 [6.0–9.0] | 7.0 [5.0–8.7] |
| Diabetes mellitus, n (%) | 7 (53.8) | 64 (49.2) |
| Cardiac disease (except essential hypertension) n (%) | 7 (53.8) | 55 (42.3) |
| Essential hypertension, n (%) | 8 (61.5) | 96 (73.8) |
| Congenital or acquired immunodeficiency, n (%) | – | 6 (4.6) |
| Chronic pulmonary disease, n (%) | – | 17 (13.1) |
| Chronic liver disease, n (%) | 1 (7.7) | 6 (4.6) |
| Rheumatic disease, n (%) | 2 (15.4) | 6 (4.6) |
| Cancer in the last 5 years (non-leukemia), n (%) | 1 (7.7) | 13 (10) |
| Tumor metastasis, n (%) | – | 2 (1.5) |
| Leukemia, n (%) | 2 (15.4)† | 2 (1.5)† |
| Past Kidney transplant, n (%) | 3 (23.1) | 20 (15.4) |
| Kidney allograft still present, n (%) | 3 (23.1)‡ | 7 (5.4)‡ |
| Medication | ||
| Erythropoiesis-stimulating agent, n (%) | 8 (61.5) | 101 (77.7) |
| Angiotensin-converting-enzyme inhibitor, n (%) | 1 (7.7) | 29 (22.3) |
| Statins, n (%) | 6 (46.2) | 66 (50.8) |
| Corticosteroid (Prednisolone 2.5–5mg/day), n (%) | 3 (23.1) | 8 (6.2) |
| Other immunossupressor/immunomodulator, n (%) | 2 (15.4) | 3 (2.3) |
| Tacrolimus, n (%) | 1 (7.7) | 2 (1.5) |
| Tacrolimus and Everolimus, n (%) | 1 (7.7) | – |
| Hydroxychloroquine, n (%) | – | 1 (0.8) |
| Non-steroidal anti-inflammatory drug, n (%) | 2 (15.4) | 9 (6.9) |
| Antithrombotic, n (%) | 8 (61.5) | 70 (53.8) |
| Antiviral, total n (%) | 1 (7.7) | 2 (1.5) |
| Aciclovir, n (%) | 1 (7.7) | – |
| Abacavir, Lamivudine, Efavirenz, n (%) | – | 1 (0.8) |
| Abacavir, Lamivudine, Raltegravir, n (%) | – | 1 (0.8) |
| Ongoing Chemotherapy, n (%) | – | 1 (0.8) |
| Anti-HBc positivity, n (%) | 1 (7.7) | 13 (10) |
| Anti-HBs positivity (>10 UI/L), n (%) | 5 (38.5) | 62 (47.7) |
| Anti-HBs positivity in anti-HBc negative, n (%) | 4 (30.8) | 50 (38.5) |
N, total number of individuals; n, number of individuals with a given event; t2, sera collected 42 days post-first vaccine dose; %, percentage; IQR, interquartile range; BMI, Body Mass Index; KT/V, measure of dialysis adequacy; nPCR, Normalized Protein Catabolic Rate; CRP, C-reactive protein; 25(OH)D3, calcifediol or vitamin D hydroxylated at the 25 Carbon; ESA, Erythropoiesis-stimulating agents; Anti-HBc, Hepatitis B core antigen antibodies; Anti-HBs, Hepatitis B surface antigen antibodies. Statistical tests to compare non-responders with responders were applied according to the type of variable (categorical—Fisher's exact test or continuous—Wilcoxon rank sum test).
W = 1,200, p-value = 0.0128; 95% CI [3.00–18.00];
p-value = 0.0414;
p-value = 0.0488; All others, not significant.