Table 3.
Multivariate analysis of antibody response.
| Covariates | Timepoint-1 | Timepoint-2 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Anti-RDB S1 IgG titer (log) | Seroconversion responseb | 50% vaccine efficacyc | Anti-RDB S1 IgG titer (log) | 50% vaccine efficacyc | ||||||
| Beta (95% CI) | P value | Beta (95% CI) | P value | Beta (95% CI) | P value | Beta (95% CI) | P value | Beta (95% CI) | P value | |
| Sex | ||||||||||
| Male vs. female | − 0.24 (− 0.30 to 0.05) | 0.17 | 0.07 (− 0.96 to 1.10) | 0.88 | 0.87 (− 0.49 to 2.25) | 0.21 | − 0.14 (− 0.32 to 0.04) | 0.13 | − 0.72 (− 1.41 to − 0.03) | 0.041 |
| Age (years) | ||||||||||
| > 55 vs. ≤ 55 | 0.01 (− 0.19 to 0.21) | 0.90 | − 0.79 (− 2.26 to 0.66) | 0.28 | 0.64 (1.15 to 2.44) | 0.48 | 0.08 (− 0.12 to 0.28) | 0.44 | 0.23 (− 0.58 to 1.05) | 0.57 |
| ECOG PS | ||||||||||
| 0a | – | – | – | – | – | – | – | – | – | – |
| 1 | − 0.03 (− 0.21 to 0.14) | 0.71 | 0.69 (− 0.42 to 1.81) | 0.22 | − 0.54 (− 2.00 to 0.91) | 0.46 | − 0.08 (− 0.26 to 0.10) | 0.38 | 0.08 (− 0.63 to 0.80) | 0.81 |
| 2 | − 0.50 (− 0.89 to -0.11) | 0.011 | − 1.24 (− 3.02 to 0.53) | 0.17 | − 20.21 (NA) | 0.99 | − 0.52 (− 0.91 to − 0.13) | 0.009 | − 1.35 (− 2.69 to − 0.02) | 0.045 |
| Treatment setting | ||||||||||
| Adjuvant or neoadjuvanta | – | – | – | – | – | – | – | – | – | – |
|
Metastatic, first line |
0.03 (− 0.17 to 0.25) | 0.71 | − 0.09 (− 1.41 to 1.22) | 0.89 | − 0.23 (− 1.80 to 1.34) | 0.77 | 0.02 (− 0.18 to 0.24) | 0.80 | 0.25 (− 0.60 to 1.11) | 0.56 |
| Metastatic, second or later line | − 0.07 (− 0.33 to 0.17) | 0.55 | − 0.87 (− 2.41 to 0.65) | 0.26 | 0.22 (− 1.61 to 2.07) | 0.80 | − 0.08 (− 0.34 to 0.16) | 0.49 | − 0.43 (− 1.43 to 0.56) | 0.39 |
| Corticosteroid therapy | ||||||||||
| Yes vs. no | − 0.51 (− 0.74 to − 0.27) | 0.001 | − 1.97 (− 3.05 to − 0.90) | < 0.001 | − 0.68 (− 2.95 to 1.59) | 0.55 | − 0.24 (− 0.48 to − 0.01) | 0.041 | − 0.26 (− 1.10 to 0.57) | 0.53 |
| Timing of active | ||||||||||
|
Treatment ≤ 28 days vs. > 28 days |
0.32 (0.08 to 0.56) |
0.008 | 1.24 (− 0.09 to 2.58) | 0.07 |
20.77 (NA) |
0.99 | 0.14 (− 0.10 to 0.38) | 0.25 | 0.21 (− 0.70 to 1.13) | 0.64 |
| Last active treatment | ||||||||||
| Targeted therapya | – | – | – | – | – | – | – | – | – | – |
| Cytotoxic chemotherapy | 0.08 (− 0.13 to 0.30) | 0.44 | 0.93 (− 0.41 to 2.29) | 0.17 | 0.88 (− 0.60 to 2.37) | 0.24 | 0.04 (− 0.18 to 0.26) | 0.72 | 0.06 (− 0.81 to 0.95) | 0.87 |
| Immune checkpoint inihibitors | − 0.22 (− 0.52 to 0.07) | 0.14 | − 0.22 (− 1.86 to 1.41) | 0.79 | − 19.85 (NA) | 0.99 | − 0.21 (− 0.51 to 0.08) | 0.15 | − 0.39 (− 0.81 to 0.95) | 0.47 |
| Hormonal therapy | 0.14 (− 0.29; 0.58) | 0.51 | 0.31 (− 2.25 to 2.88) | 0.80 | 21.23 (NA) | 0.99 | 0.08 (− 0.35 to 0.52) | 0.69 | 0.94 (− 1.36 to 3.26) | 0.42 |
| Chemotherapy & biologics | − 0.36 (− 0.66 to − 0.07) | 0.014 | − 0.81 (− 2.41 to 0.77) | 0.31 | − 19.74 (NA) | 0.99 | − 0.26 (− 0.56 to 0.02) | 0.07 | − 0.64 (− 1.74 to 0.46) | 0.25 |
| T helper cell level before booster | ||||||||||
| High vs. low | 0.15 (− 0.06 to 0.36) | 0.16 | 0.47 (− 0.65 to 1.60) | 0.41 | 1.13 (− 0.85 to 3.11) | 0.26 | 0.05 (− 0.15 to 0.26) | 0.59 | 0.27 (− 0.50 to 1.05) | 0.48 |
| B cell level before booster | ||||||||||
| High vs. low | 0.20 (0.02 to 0.40) | 0.047 | 1.60 (0.51 to 2.69) | 0.004 | − 0.74 (− 2.21 to 0.73) | 0.32 | 0.19 (− 0.01 to 0.39) | 0.05 | 1.00 (0.27 to 1.72) | 0.007 |
| B cell level after booster | ||||||||||
| High vs. low | – | – | – | – | – | – | 0.22 (0.05 to .040) | 0.01 | 0.97 (0.33 to 1.65) | 0.003 |
Statistically significant P values are highlighted in bold. P values derived from parametric 2-sided Wald’s χ2 test with Bonferroni (α = 0.01) correction for multiple comparisons. A two-sided P value of < 0.05 was considered statistically significant. RBD-S1, receptor binding domain of the S1 subunit of the SARS-CoV-2 spike protein; log, logarithmic values; IgG, immunoglobulin G; AU, arbitrary unit; CI, confidence intervals; ECOG PS, Eastern Cooperative Oncology Group Performance Status; NA, not applicable. aReference category; bSeroconversion response at cut-off ≥ 50 AU/mL; c50% vaccine efficacy response at cut-off ≥ 4446 AU/mL; Timepoint-1 denotes antibody response assessment before the third dose of tozinameran; Timepoint-2 denotes antibody response assessment four weeks after the third dose of tozinameran.