TABLE 1.
Baseline demographic characteristics, outcomes, adverse reactions, and immunogenicity of the first dose of CoronaVac in kidney transplant recipients
| Parameters | Overall (N = 3354) | Immunogenicity cohort (n = 942) | P | IgG (+) D28 (n = 143) | IgG (−) D28 (n = 799) | P |
|---|---|---|---|---|---|---|
| Demographic characteristics | ||||||
| Median age, (IQR), y | 52 (44–60) | 50 (43–56) | <0.001 | 47 (41–54) | 51 (43–57) | <0.001 |
| 30–60 y, n (%) | 2552 (76) | 844 (90) | 136 (95) | 708 (89) | ||
| >60 y, n (%) | 802 (24) | 98 (10) | 7 (5) | 91 (11) | ||
| Male gender, n (%) | 2008 (60) | 544 (58) | 0.269 | 76 (53) | 468 (59) | 0.556 |
| Diabetes mellitus, n (%) | 333 (10) | 93 (10) | >0.99 | 10 (7) | 83 (10) | 0.208 |
| Organ, n (%) | ||||||
| Kidney | 3239 (96) | 835 (89) | <0.001 | 140 (98) | 695 (87) | <0.001 |
| Simultaneous pancreas-kidney | 115 (4) | 107 (11) | 3 (2) | 104 (13) | ||
| Median length of transplant, (IQR), y | 7 (3–12) | 6 (3–11) | <0.001 | 6 (3–11) | 6 (3–11) | >0.99 |
| Maintenance immunosuppressive regimen, n (%) | ||||||
| TAC-Pred-AZA | 1002 (30) | 282 (30) | 0.231 | 34 (24) | 248 (31) | 0.253 |
| TAC-Pred-MPA | 1396 (42) | 402 (43) | 66 (46) | 336 (42) | ||
| CSA-Pred-AZA | 376 (11) | 89 (9) | 11 (8) | 78 (10) | ||
| TAC-Pred-mTORi | 306 (9) | 102 (11) | 18 (12) | 84 (10) | ||
| Other | 274 (8) | 67 (7) | 14 (10) | 53 (7) | ||
| Outcomes | ||||||
| COVID-19 diagnosis after the first dose, n (%) | 61 (1.8) | |||||
| Median age, (IQR), y | 53 (47–59) | |||||
| Time from first dose to COVID-19 (d), n (%) | ||||||
| ≤7 | 13 (21) | |||||
| 8–14 | 23 (38) | |||||
| >14 | 25 (41) | |||||
| Need for hospitalization, n (%) | 44 (72) | |||||
| Need for intensive care, n (%) | 27 (44) | |||||
| Lethality from COVID-19, n (%) | 16 (26) | |||||
| Adverse reactions to the vaccine, n (%) (n = 3274) | ||||||
| Local pain or tenderness | 378 (11) | |||||
| Headache | 178 (5) | |||||
| Myalgia | 160 (5) | |||||
| Runny nose | 113 (3) | |||||
| Diarrhea | 93 (3) | |||||
| Sore throat | 65 (2) | |||||
| Fever | 39 (1) | |||||
| Serologic status before vaccination, n (%) | ||||||
| Negative | 3182 (95) | 942 | — | — | ||
| Positive | 122 (4) | 0 | — | — | ||
| Indeterminate | 50 (1) | 0 | — | — | ||
| Serologic status after the first dose, n (%) | ||||||
| Negative (<50 AU/mL) | — | 799 (85) | ||||
| Positivea | — | 143 (15); 95% CI, 13%-17% | ||||
| 30–60 y, n (%) | 134 (16); 95% CI, 14%-19% | |||||
| >60 y, n (%) | 9 (8); 95% CI, 3%-13% |
aP = 0.026 for comparison between the 2 age ranges.
AZA, azathioprine; CI, confidence interval; COVID-19, coronavirus disease 2019; CSA, cyclosporine; IgG, immunoglobulin G; IQR, interquartile range; MPA, mycophenolate; mTORi, mammalian target of rapamycin inhibitors; Pred, prednisone; TAC, tacrolimus.