Table 4.
Antibody Titer | Time Point | Parameter | Group |
p-value | |
---|---|---|---|---|---|
Vaccine (N = 397) | Placebo (N = 133) | ||||
IgG (ELISA) | V1 | Seropositive rate n(%) (95% CI) |
44 (11.08) (8.36–14.55) |
14 (10.53) (6.37–16.89) |
0.859**) |
GMT*) (95% CI) Median |
220.27 (212.87–227.93) 200.00 |
220.37 (206.45–235.24) 200.00 |
0.990***) | ||
V3 | Seropositive rate n(%) (95 %CI) Seroconversion n(%) (95% CI) GMT*) (95% CI) Median |
396 (99.74) (99.26–100) 387 (97.48) (95.43–98.63) 5181.19 (4746.13–5656.14) 5333.35 |
7 (5.29) (1.47–9.06) 1 (0.75) (0.13–4.14) 223.61 (209.08–239.47) 200.00 |
<0.001**) < 0.001**) < 0.001***) |
|
Neutralization Antibody | V1 | Seropositive rate n(%) (95% CI) GMT*) (95% CI) Median |
0 (0–0.96) 2.00 (−) – |
0 (0–2.81) 2.00 (−) – |
– – |
V3 | Seropositive rate n(%) (95% CI) Seroconversion n (%) (95% CI) GMT*) (95% CI) Median |
380 (95.72) (93.25–97.31) 346 (87.15) (83.50–90.09) 15.76 (14.57–17.04) 16 |
1 (0.75) (0.13–4.14) 0 (0.00) (0–2.81) 2.02 (1.98–2.05) 2 |
<0.001**) < 0.001**) < 0.001***) |
*) The comparison results after logarithmic transformation. **) Chi-square test; ***) t-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 seronegative (titer < 1:8) to seropositive (titer ≥ 1:8); or a 4-fold increase from baseline titers if titer at baseline ≥ 1:8.