Table 2.
Neutralizing antibodies induced by SCB-2019.
|
SARS-CoV-2-naïve population (Immunogenicity-PPS) |
SARS-CoV-2-exposed population (Immunogenicity-FAS Exposed) |
|||||||
|---|---|---|---|---|---|---|---|---|
|
SCB-2019 N = 381 |
Placebo N = 47 |
SCB-2019 N = 235 |
Placebo N = 28 |
|||||
| Endpoint | n | Value (95 % CI) | n | Value (95 % CI) | n | Value (95 % CI) | n | Value (95 % CI) |
| Wild-type SARS-CoV-2 neutralizing antibodies (IU/mL) | ||||||||
| Day 1 | ||||||||
| Mean GMT | 219 | 12.7 (12.6–12.9) | 27 | 12.5 (–) | 118 | 26.4 (22.3–31.3) | 18 | 32.7 (16.3–65.8) |
| >LLoQ, % | 219 | 0.9 (0.1–3.3) | 27 | 0.0 (0.0–12.8) | 118 | 44.1 (34.9–53.5) | 18 | 38.9 (17.3–64.3) |
| Day 22 | ||||||||
| Mean GMT | 215 | 15.7 (14.1–17.5) | 28 | 12.8 (12.4–13.3) | 118 | 1276.1 (999.3–1629.7) | 18 | 42.1 (20.6–86.6) |
| GMFR | 212 | 1.2 (1.1–1.4) | 27 | 1.0 (1.0–1.1) | 118 | 48.3 (36.9–63.2) | 18 | 1.3 (0.7–2.3) |
| SCR, % | 212 | 4.2 (2.0–7.9) | 27 | 0.0 (0.0–12.8) | 118 | 92.4 (86.0–96.5) | 18 | 5.6 (0.1–27.3) |
| >LLoQ, % | 215 | 9.3 (5.8–14.0) | 28 | 0.0 (0.0–12.3) | 118 | 97.5 (92.7–99.5) | 18 | 61.1 (35.7–82.7) |
| Day 36 | ||||||||
| Mean GMT | 220 | 224 (194.0–258.7) | 28 | 12.8 (12.4–13.3) | 118 | 1831.4 (1545.9–2169.8) | 18 | 58.3 (26.6–128.1) |
| GMFR | 217 | 17.5 (15.1–20.2) | 27 | 1.0 (1.0–1.1) | 118 | 69.3 (55.9–85.8) | 18 | 1.8 (0.8–3.8) |
| SCR, % | 217 | 82.5 (76.8–87.3) | 27 | 0.0 (0.0–12.8) | 118 | 98.3 (94.0–99.8) | 18 | 16.7 (3.6–41.4) |
| >LLoQ, % | 220 | 96.8 (93.6–98.7) | 28 | 0.0 (0.0–12.3) | 118 | 100.0 (96.9–100.0) | 18 | 61.1 (35.7–82.7) |
| Pseudovirus neutralizing antibodies (IU/mL) | ||||||||
| Day 1 | ||||||||
| Mean GMT | 219 | 15.8 (15.5–16.1) | 27 | 15.5 (–) | 119 | 47.6 (39.2–57.9) | 18 | 56.7 (27.5–117.0) |
| >LLoQ, % | 219 | 1.4 (0.3–4.0) | 27 | 0.0 (0.0–12.8) | 119 | 63.9 (54.6–72.5) | 18 | 61.1 (35.7–82.7) |
| Day 22 | ||||||||
| Mean GMT | 214 | 22.9 (20.1–26.1) | 28 | 15.9 (15.0–16.9) | 118 | 1559.9 (1266.3–1921.5) | 18 | 70.8 (32.5–154.3) |
| GMFR | 212 | 1.5 (1.3–1.6) | 27 | 1.0 (1.0–1.1) | 118 | 32.4 (25.0–42.2) | 18 | 1.2 (0.6–2.4) |
| SCR, % | 212 | 7.5 (4.4–12.0) | 27 | 0.0 (0.0–12.8) | 118 | 90.7 (83.9–95.3) | 18 | 5.6 (0.1–27.3) |
| >LLoQ, % | 214 | 19.6 (14.5–25.6) | 28 | 3.6 (0.1–18.3) | 118 | 97.5 (92.7–99.5) | 18 | 66.7 (41.0–86.7) |
| Day 36 | ||||||||
| Mean GMT | 220 | 540.3 (472.8–617.5) | 28 | 20.3 (14.8–27.8) | 119 | 2192.1 (1931.7–2487.6) | 18 | 74.0 (35.3–155.0) |
| GMFR | 218 | 34.1 (29.8–39.0) | 27 | 1.3 (1.0–1.8) | 119 | 46.0 (37.1–57.0) | 18 | 1.3 (0.7–2.5) |
| SCR, % | 218 | 93.6 (89.5–96.4) | 27 | 3.7 (0.1–19.0) | 119 | 95.8 (90.5–98.6) | 18 | 11.1 (1.4–34.7) |
| >LLoQ, % | 220 | 98.2 (95.4–99.5) | 28 | 14.3 (4.0–32.7) | 119 | 100.0 (96.9–100.0) | 18 | 66.7 (41.0 –86.7) |
Abbreviations: CI, confidence interval; FAS, full analysis set; GMFR, geometric mean fold rise; GMT, geometric mean titer; LLoQ, lower limit of quantification; PPS, per protocol set; SCR, seroconversion rate.
N is the number of participants in each arm; n is the number of participants with available data.
Titer value measured as below LLoQ of the assay was set to LLoQ/2.