Table 3.
Antibody response to non-vaccine antigens expressed as Geometric Mean of arbitrary response units (ARU) of anti-GII.2, anti-GII.4, and anti-GII.6 VLP IgG at scheduled time points for each study group.
| Time point | ||||||
|---|---|---|---|---|---|---|
| IgG | Study group | Parameter 95% CI |
Day 1 | Day 8 | Day 29 | Day 57 |
| Anti-GII.2 OC08154 (2008) | rNV-2v 50 µg | Geomean* | 2.54 | 7.90 | 6.66 | 5.46 |
| 95% CI | 1.72–3.75 | 5.52–11.31 | 4.83–9.19 | 3.95–7.54 | ||
| rNV-2v 150 µg | Geomean | 2.01 | 9.51 | 7.05 | 5.24 | |
| 95% CI | 1.54–2.61 | 6.21–14.58 | 5.27–9.43 | 3.94–6.96 | ||
| Placebo | Geomean | 2.18 | 2.22 | 2.54 | 2.45 | |
| 95% CI | 1.55–3.06 | 1.57–3.14 | 1.79–3.61 | 1.68–3.59 | ||
| Anti-GII.4 Washington (2018) | rNV-2v 50 µg | Geomean | 2.75 | 11.40 | 11.54 | 8.83 |
| 95% CI | 2.01–3.77 | 8.07–16.11 | 8.72–15.27 | 6.17–12.63 | ||
| rNV-2v 150 µg | Geomean | 1.56 | 16.55 | 11.18 | 6.92 | |
| 95% CI | 1.16–2.11 | 11.70–23.41 | 8.83–14.17 | 4.98–9.62 | ||
| Placebo | Geomean | 1.71 | 1.71 | 1.74 | 1.77 | |
| 95% CI | 1.26–2.33 | 1.22–2.40 | 1.27–2.40 | 1.25–2.51 | ||
| Anti-GII.6 Maryland (2018) | rNV-2v 50 µg | Geomean | 1.88 | 3.35 | 3.91 | 3.11 |
| 95% CI | 1.27–2.76 | 2.16–5.19 | 2.62–5.82 | 2.06–4.71 | ||
| rNV-2v 150 µg | Geomean | 1.39 | 4.47 | 2.84 | 2.28 | |
| 95% CI | 1.12–1.72 | 2.74–7.31 | 1.91–4.23 | 1.65–3.15 | ||
| Placebo | Geomean | 1.27 | 1.48 | 1.55 | 1.48 | |
| 95% CI | 1.08–1.50 | 1.15–1.90 | 1.21–1.97 | 1.14–1.91 | ||
CI, confidence interval; Geomean, geometric mean antibody concentration.
*Geometric mean values are expressed as arbitrary response units (ARU) defined as the reciprocal of the dilution factor or c value (inflection point).