Table 2.
Antibody response to vaccine antigens expressed as Geometric Mean Titer (EU/ml) of anti-GI.4 and anti-GII.4 VLP IgA at scheduled time points for each study group.
| Time point | ||||||||
|---|---|---|---|---|---|---|---|---|
| IgA | Study group | Parameter 95% CI |
Day 1 | Day 8 | Day 29 | Day 57 | Day 183 | Day 365 |
| Anti-GI.4 | rNV-2v 50 µg | Geomean* | 175.6 | 7,913.3 | 3,076.1 | 1,968.6 | 1,184.3 | 765.1 |
| 95% CI | 77.6–397.2 | 3,802.8–1,6467.0 | 1,535.2–6,163.5 | 1,000.3–3,874.4 | 574.2–2,442.6 | 377.3–1,551.4 | ||
| rNV-2v 150 µg | Geomean | 139.0 | 17,767.9 | 3,586.5 | 1,879.6 | 961.6 | 665.0 | |
| 95% CI | 77.9–247.8 | 10,800.8–29,229.3 | 2,260.6–5,689.9 | 1,183.7–2,984.7 | 596.8–1,549.2 | 410.6–1,076.9 | ||
| Placebo | Geomean | 159.3 | 152.2 | 146.2 | 152.1 | 193.6 | 158.7 | |
| 95% CI | 76.5–331.7 | 74.1–312.8 | 304.3 70.2 | 74.8–309.4 | 97.7–383.7 | 75.9–331.8 | ||
| Anti-GII.4 | rNV-2v 50 µg | Geomean | 209.6 | 3,437.5 | 1,522.2 | 966.8 | 623.9 | 456.6 |
| 95% CI | 105.5–416.2 | 1,996.2–5,919.6 | 933.5–2,482.4 | 587.9–1,589.7 | 372.1–1,046.1 | 268.4–776.6 | ||
| rNV-2v 150 µg | Geomean | 140.5 | 5,743.1 | 1,205.4 | 695.4 | 489.8 | 362.0 | |
| 95% CI | 59.9–329.7 | 3,552.0–9,285.7 | 670.7–2,166.4 | 376.0–1,286.0 | 250.4–958.0 | 183.2–715.5 | ||
| Placebo | Geomean | 131.3 | 118.6 | 136.7 | 131.8 | 172.9 | 113.7 | |
| 95% CI | 54.0–319.1 | 44.4–317.1 | 55.2–338.5 | 55.4–313.4 | 79.5–376.1 | 41.7–310.4 | ||
CI, confidence interval; Geomean, geometric mean antibody concentration.
*Geometric mean values are expressed as EU/ml (ELISA units per milliliter).