Table 2.
Seroconversion rate of S1 IgG, RBD IgG, surrogate neutralizing IgG and S1 IgA in the participants
| Pooled |
Seronegative |
Seropositive |
||||
|---|---|---|---|---|---|---|
| SpikoGen® | Placebo | SpikoGen® | Placebo | SpikoGen® | Placebo | |
| sVNT | ||||||
| Day 21 SCR 95% CI | 128/307 (41.69) (36.12–47.43) | 15/86 (17.44) (10.10–27.13) |
40/165 (24.24) (17.92–31.52) |
5/50 (10) (3.33–21.81) |
88/142 (61.97) (53.45–69.98) |
10/36 (27.78) (14.20–45.19) |
| Day 35 SCR 95% CI |
233/299 (77.93) (72.79–82.50) |
17/83 (20.48) (12.41–30.76) |
111/158 (70.25) (62.47–77.25) |
4/48 (8.33) (2.32–19.98) |
122/141 (86.52) (79.76–91.69) |
13/35 (37.14) (21.47–55.08) |
| S1-IgG | ||||||
| Day 21 SCR 95% CI |
89/307 (28.99) (23.98–34.41) |
2/86 (2.33) (0.28–8.15) |
20/165 (12.12) (7.56–18.10) |
1/50 (2) (0.05–10.65) |
69/142 (48.59) (40.13–57.12) |
1/36 (2.78) (0.07–14.53) |
| Day 35 SCR 95% CI |
190/299 (63.55) (57.81–69.01) |
6/83 (7.23) (2.70–15.07) |
91/158 (57.59) (49.49–65.41) |
4/48 (8.33) (2.32–19.98) |
99/141 (70.21) (61.94–77.62) |
2/35 (5.71) (0.70–19.16) |
| RBD-IgG | ||||||
| Day 21 SCR 95% CI |
92/307 (29.97) (24.90–35.43) |
6/86 (6.98) (2.60–14.57) |
26/165 (15.76) (10.56–22.23) |
3/50 (6) (1.25–16.55) |
66/142 (46.48) (38.07–55.03) |
3/36 (8.33) (1.75–22.47) |
| Day 35 SCR 95% CI |
162/299 (54.18) (48.35–59.93) |
4/83 (4.82) (1.33–11.88) |
81/158 (51.27) (43.20–59.29) |
2/48 (4.17) (0.51–14.25) |
81/141 (57.45) (48.85–65.73) |
2/35 (5.71) (0.70–19.16) |
| S1-IgA | ||||||
| Day 21 SCR 95% CI |
71/307 (23.13) (18.52–28.25) |
1/86 (1.16) (0.03–6.31) |
13/165 (7.88) (4.26–13.10) |
0/50 (0) (0.03–7.11) |
58/142 (40.85) (32.68–49.40) |
1/36 (3) (0.07–14.53) |
| Day 35 SCR 95% CI |
92/299 (30.77) (25.58–36.34) |
1/83 (1.20) (0.03–6.53) |
24/158 (15.19) (9.98–21.75) |
0/48 (0) (0–7.40) |
68/141 (48.23) (39.74–56.79) |
1/35 (2.86) (0.07–14.92) |
CI, confidence interval; cVNT, conventional virus neutralization test; SCR, seroconversion rate; sVNT, surrogate virus neutralization test; RBD, receptor binding domain.
Percentages for seroconversion rate (SCR) were calculated as the number of participants who reported the event divided by the number of participants in the Per-Protocol Set within each visit multiply 100. The 95% confidence interval (CI) for SCR was calculated using the exact Clopper-Pearson method.