Table 5.
Antibody |
Time Point |
Parameter |
Batch |
p-value** |
||
---|---|---|---|---|---|---|
Batch 20200308 (n = 131) |
Batch 20200412 (n = 134) |
Batch 20200419 (n = 132) |
||||
IgG (ELISA) | V1 | Seropositive rate n(%) (95% CI) |
14 (10.70) (6.47–17.14) |
16 (11.94) (7.48–18.52) |
14 (10.61) (6.42–17.02) |
0.927**) |
GMT*) (95% CI) Median |
215.16 (205.70–225.05) 200.00 |
223.40 (208.36–239.52) 200.00 |
222.26 (209.08–236.27) 200.00 |
0.384***) |
||
V3 | Seropositive rate n (%) (95% CI) Seroconversion n (%) (95% CI) GMT*) (95% CI) Median |
131 (1 0 0) (97.15–100) 126 (96.18) (92.38–98.36) 5093.78 (4369.78–5937.59) 5105.05 |
133 (99.25) (95.89–99.87) 131 (97.76) (93.62–99.24) 5421.63 (4656.29–6312.77) 5787.62 |
132 (1 0 0) (97.17–100) 130 (98.48) (94.64–99.58) 5032.34 (4314.30–5869.76) 5302.40 |
0.374**) 0.476**) 0.898***) |
|
Neutralization Antibody | V1 | Seropositive rate n(%) (95% CI) |
0 (0–2.85) |
0 (0–2.94) |
0 (0–2.91) |
– |
GMT*) (95% CI) Median |
2.00 – – |
2.00 – – |
2.00 – – |
– | ||
V3 | Seropositive rate n (%) (95% CI) Seroconversion n (%) (95% CI) GMT*) (95% CI) Median |
126 (96.18) (91.38–98.36) 118 (90.08) (83.76–94.11) 15.97 (14.03–18.18) 16.00 |
127 (94.78) (89.61–97.45) 119 (88.81) (82.35–93.10) 16.59 (14.47–19.02) 16.00 |
127 (96.21) (91.44–98.37) 109 (82.58) (75.21–88.10) 14.75 (12.78–17.02) 16.00 |
0.803**) 0.150**) 0.470***) |
*) The comparison results after logarithmic transformation. **) Chi-square test; ***) ANOVA (F-test).
V1 = before injection.
V3 = 14 days after second injection.
IgG seropositive = titer > 200; seroconversion = four-fold increasing anti-RBD antibody IgG titer compare to baseline 14 days after the second dose.
Antibody neutralization seropositive = titer ≥ 1:4; seroconversion = a change from titer < 1:8 to titer ≥ 1:8; or a 4-fold increase from baseline titers if titer ≥ 1:8 14 days after the second dose.