Table 4.
Antibody response to vaccine and non-vaccine antigens expressed as median of fold increase from baseline (day 1) for anti-VLP IgG at scheduled time points for each study group.
| Time point | |||||
|---|---|---|---|---|---|
| IgG Fold Increase | Study group | Median | Day 8 | Day 29 | Day 57 |
| Min - Max | |||||
| Anti-GI.4 Chiba 407 (1987) | rNV-2v 50 µg | Median | 21.3 | 19.5 | 15.1 |
| Min - Max | 1.3 - 78.3 | 1.5 - 75.0 | 1.5 - 85.4 | ||
| rNV-2v 150 µg | Median | 35.2 | 27.7 | 21.4 | |
| Min - Max | 4.1 - 245.3 | 3.6 - 133.5 | 2.9 - 145.6 | ||
| Placebo | Median | 1.0 | 1.0 | 1.0 | |
| Min - Max | 0.8 – 1.1 | 0.9 – 1.3 | 0.9 – 1.3 | ||
| Anti-GI.3 (2002) | rNV-2v 50 µg | Median | 4.0 | 4.0 | 2.0 |
| Min - Max | 1.0 – 8.0 | 1.0 – 16.0 | 0.5 – 16.0 | ||
| rNV-2v 150 µg | Median | 4.0 | 2.0 | 2.0 | |
| Min - Max | 1.0 – 32.0 | 1.0 – 32.0 | 1.0 – 8.0 | ||
| Placebo | Median | 1.0 | 1.0 | 1.0 | |
| Min - Max | 0.5 – 2.0 | 0.5 – 2.0 | 0.5 – 2.0 | ||
| Anti-GII.4 (1999) | rNV-2v 50 µg | Median | 6.0 | 4.0 | 4.0 |
| Min - Max | 1.0 – 32.0 | 1.0 – 32.0 | 1.0 – 32.0 | ||
| rNV-2v 150 µg | Median | 8.0 | 4.0 | 4.0 | |
| Min - Max | 1.0 – 128.0 | 2.0 – 64.0 | 1.0 – 32.0 | ||
| Placebo | Median | 1.0 | 1.0 | 1.0 | |
| Min - Max | 0.5 – 2.0 | 0.5 – 1.0 | 0.5 – 1.0 | ||
| Anti-GII.4 Aomori 2 (2006) | rNV-2v 50 µg | Median | 4.8 | 5.1 | 5.2 |
| Min - Max | 1.1 - 45.3 | 1.4 - 83.0 | 1.5 - 78.8 | ||
| rNV-2v 150 µg | Median | 12.4 | 8.0 | 7.4 | |
| Min - Max | 1.4 - 193.0 | 2.8 - 121.3 | 2.2 - 53.3 | ||
| Placebo | Median | 0.9 | 1.0 | 1.0 | |
| Min - Max | 0.8 – 1.3 | 0.9 – 1.9 | 0.8 – 1.4 | ||
| Anti-GII.4 Sydney (2012) | rNV-2v 50 µg | Median | 4.0 | 4.0 | 3.0 |
| Min - Max | 0.5 - 32 | 0.5 - 32 | 0.5 - 32 | ||
| rNV-2v 150 µg | Median | 8.0 | 4.0 | 4.0 | |
| Min - Max | 1.0 – 64.0 | 1.0 – 64.0 | 1.0 – 16.0 | ||
| Placebo | Median | 1.0 | 1.0 | 0.5 | |
| Min - Max | 0.5 – 2.0 | 0.5 – 2.0 | 0.5 – 1.0 | ||
| Anti-GII.4 Washington (2018) | rNV-2v 50 µg | Median | 3.5 | 3.6 | 3.0 |
| Min - Max | 1.0 - 35.6 | 1.4 - 38.8 | 0.4 - 26.5 | ||
| rNV-2v 150 µg | Median | 10.7 | 7.5 | 5.1 | |
| Min - Max | 2.0 - 49.3 | 1.9 - 30.1 | 0.7 - 14.7 | ||
| Placebo | Median | 1.0 | 1.0 | 1.0 | |
| Min - Max | 0.4 - 11.2 | 0.4 - 6.6 | 0.3 - 7.2 | ||
| Anti-GII.2 OC08154 (2008) | rNV-2v 50 µg | Median | 2.2 | 2.3 | 1.7 |
| Min - Max | 0.8 - 43.7 | 0.4 - 23.4 | 0.8 - 19.2 | ||
| rNV-2v 150 µg | Median | 3.7 | 3.0 | 2.6 | |
| Min - Max | 0.6 - 33.0 | 1.3 - 12.5 | 0.9 - 8.8 | ||
| Placebo | Median | 1.0 | 1.0 | 1.0 | |
| Min - Max | 0.5 - 4.1 | 0.6 - 3.7 | 0.5 - 4.3 | ||
| Anti-GII.6 Maryland (2018) | rNV-2v 50 µg | Median | 1.4 | 2.1 | 1.4 |
| Min - Max | 0.7 - 8.7 | 0.7 - 9.7 | 0.7 - 4.0 | ||
| rNV-2v 150 µg | Median | 3.9 | 2.4 | 1.5 | |
| Min - Max | 0.5 - 19.9 | 0.4 - 7.2 | 0.8 - 5.2 | ||
| Placebo | Median | 1.0 | 1.0 | 1.0 | |
| Min - Max | 0.4 - 3.6 | 0.6 - 2.9 | 0.4 - 3.8 | ||
| Anti-GII.17 Kawasaki (2015) | rNV-2v 50 µg | Median | 3.0 | 2.0 | 2.0 |
| Min - Max | 0.5 – 32.0 | 0.5 – 16.0 | 0.5 – 16.0 | ||
| rNV-2v 150 µg | Median | 6.0 | 4.0 | 2.0 | |
| Min - Max | 2.0 – 64.0 | 1.0 – 16.0 | 1.0 – 16.0 | ||
| Placebo | Median | 1.0 | 1.0 | 1.0 | |
| Min - Max | 0.5 – 2.0 | 0.5 – 2.0 | 0.5 – 1.0 | ||