Table 2.
Association of prevaccination demographic and clinical characteristics with antibody responses 3 weeks after the first dose of the Pfizer BTN162b2 vaccine.
| Univariate analysis |
Multivariate analysis |
|||||
|---|---|---|---|---|---|---|
| Anti-s-RBD IgG negative (n = 102) | Anti-s-RBD IgG positive (n = 29) | p value | OR | 95% CI | p value | |
| Age at LT (years) | 59.5 (54.1-63.4) | 54.6 (48.3-59.1) | 0.008 | |||
| Male sex | 74 (72.6) | 18 (62.1) | 0.276 | |||
| BMI (kg/m2) | 25.5 (23.4-28.7) | 26.4 (23.8-29.3) | 0.407 | |||
| Months between LT and vaccination | 84.8 (36.7-189) | 153.9 (72.4-194.6) | 0.040 | |||
| Etiology: HCV, HBV, AH, AI, other (%) | 21, 18, 49, 7, 7 (20.6, 17.6, 48.0, 6.9, 6.9) | 7, 3, 9, 6, 4 (24.1, 10.3, 31.0, 20.7, 13.8) | 0.092 | |||
| HCC | 38 (37.3) | 9 (31.0) | 0.538 | |||
| DM | 37 (36.3) | 9 (31.0) | 0.602 | |||
| Dyslipidemia | 23 (22.6) | 6 (20.7) | 0.831 | |||
| Alcohol consumption >40 g/day | 9 (8.8) | 0 (0.0) | 0.097 | <0.001 | <0.001-<0.001 | <0.001 |
| HTN | 44 (43.1) | 14 (48.3) | 0.623 | |||
| Presence of esophageal varices | 5 (4.9) | 1 (3.5) | 0.741 | |||
| Presence of ascites | 3 (2.9) | 1 (3.5) | 0.889 | |||
| IS treatment | ||||||
| Tacrolimus | 63 (61.8) | 22 (75.9) | 0.160 | |||
| Cyclosporine | 26 (25.5) | 5 (17.2) | 0.356 | |||
| MMF | 57 (55.9) | 1 (17.1) | <0.001 | |||
| Everolimus | 10 (9.8) | 2 (4.9) | 0.632 | |||
| Prednisone | 11 (10.8) | 2 (6.9) | 0.537 | |||
| Double-triple IS including MMF | 50 (49.0) | 1 (3.5) | <0.001 | |||
| MMF+T; +C; +E; +P; +C+P (%) | 29, 16, 2, 1, 2 (28.4, 15.7, 2.0, 1.0, 2.0) | 1, 0, 0, 0, 0 (3.4, 0.0, 0.0, 0.0, 0.0) | ||||
| Double-triple IS excluding MMF | 12 (11.8) | 2 (6.9) | 0.454 | |||
| T+E, T+A, T+P, C+P, T+E+P (%) | 3, 1, 5, 1, 2 (2.9, 1.0, 4.9, 1.0, 2.0) | 0, 0, 2, 0, 0 (0.0, 0.0, 6.9, 0.0, 0.0) | ||||
| Any double IS therapy | 58 (56.9) | 3 (10.3) | <0.001 | |||
| Any triple IS therapy | 4 (3.9) | 0 (0.0) | 0.279 | |||
| Serum IS drug levels or daily dose# | ||||||
| Tacrolimus (ng/ml) | 4.26 ±0.46 | 3.63 ±0.46 | 0.678 | |||
| Cyclosporine (ng/ml) | 12.4 ±2.52 | 9.62 ±4.68 | 0.467 | |||
| Everolimus (ng/ml) | 0.45 ±0.16 | 0.34 ±0.25 | 0.523 | |||
| MMF (g/day) | 0.93 ±0.09 | 0.034 ±0.03 | <0.001 | 0.121 | 0.032-0.461 | 0.002 |
| Prednisone (mg/day) | 0.56 ±0.18 | 0.34 ±0.27 | 0.554 | |||
| IS levels with respect to reference# | ||||||
| Below | 48 (47.1) | 15 (51.7) | 0.657 | |||
| Above | 6 (5.9) | 0 (0.0) | 0.181 | |||
| Hemoglobin (g/dl) | 13.2 (12.1-14.8) | 14.0 (12.9-14.7) | 0.296 | |||
| Leukocytes (n/μl) | 5,780 (4,500-6,610) | 5,540 (4,680-6,330) | 0.727 | |||
| Neutrophils (n/μl) | 3,340 (2,770-4,180) | 3,420 (2,700-4,100) | 0.775 | |||
| Albumin (g/dl) | 4.24 (4.03-4.53) | 4.23 (4.10-4.50) | 0.857 | |||
| Bilirubin (mg/dl) | 0.59 (0.42-0.89) | 0.69 (0.43-1.01) | 0.351 | |||
| eGFR (ml/min/1.73 m2) | 58.0 (45.3-70.6) | 72.9 (50.7-84.2) | 0.009 | 1.031 | 1.005-1.058 | 0.016 |
| AST (U/ml) | 18 (14-23) | 21 (16-26) | 0.098 | |||
| ALT (U/ml) | 15 (11-23) | 19 (14-21) | 0.041 | |||
| INR | 1.04 (0.98-1.10) | 1.10 (1.00-1.20) | 0.083 | |||
| 25-OH-Vitamin D (ng/ml) | 31.0 (25.6-35.0) | 32.0 (26.7-36.2) | 0.437 | |||
Logistic model estimation parameters: pseudo R2 = 0.319; area under the ROC curve = 0.866; correct classification = 85.5%.
Association between prevaccination demographic and clinical characteristics of COVID-19-naïve liver transplanted patients (n = 131) with regards to the development of a positive (≥0.8 U/ml) or negative (<0.8 U/ml) anti-SARS-CoV-2 s-RBD antibody response, as assessed 3 weeks (19 days) after the first dose of the Pfizer BTN162b2 vaccine. Categorical parameters are presented as frequencies (%), and the Pearson chi-squared test was used for statistical comparisons. Continuous variables are presented as medians (IQR), and serum immunosuppressive drug levels are presented as the means (±SE). The rank-sum test (Mann-Whitney) was used for statistical comparisons. Stepwise regression with a forward approach was used to discriminate independent predictive variables to achieve a positive antibody response after vaccination in a multivariate logistic model analysis.
A, azathioprine; AH, alcoholic hepatitis; AI, autoimmune hepatitis; ALT, alanine aminotransferase; AST, aspartate aminotransferase; C, cyclosporine; DM, diabetes mellitus; E, everolimus; eGFR, estimated glomerular filtration rate; HCC, hepatocellular carcinoma; HTN, arterial hypertension; INR, international normalized ratio; IS, immunosuppressive; LT, liver transplantation; NASH, non-alcoholic steatohepatitis, MMF, mycophenolate mofetil; P, prednisone; T, tacrolimus.
reference blood levels evaluated within 1 month before vaccination for each IS drug were calculated in accordance with Cillo et al.35