Table 4.
Serum antibodies blocking GI.4 and GII.4 VLP binding to histo-blood group antigen at scheduled time points for each study group.
| Time point | ||||||||
|---|---|---|---|---|---|---|---|---|
| Blocking Assay | Study group | Parameter95% CI | Day 1 | Day 8 | Day 29 | Day 57 | Day 183 | Day 365 |
| Anti-GI.4 | rNV-2v/50 | Geomean* 95% CI |
62.3 45.6-100.6 |
837.0 843.7-2580.6 |
414.1 406.2-1200.9 |
349.1 331.6-866.2 |
152.1 136.0-351.9 |
109.9 83.4-247.1 |
| GMFR 95% CI |
ND ND |
13.4 14.1-50.0 |
6.6 5.5-20.7 |
5.6 4.7-14.0 |
2.4 2.0-5.3 |
1.8 1.3-3.3 |
||
| rNV-2v/150 | Geomean 95% CI |
52.8 44.5-65.6 |
1627.2 1678.4-4432.4 |
569.7 567.1-1411.6 |
422.1 371.6-830.8 |
170.7 141.4-389.1 |
94.6 68.0-205.7 |
|
| GMFR 95% CI |
ND ND |
30.8 32.1-87.9 |
10.8 10.5-27.6 |
8.0 6.9-16.2 |
3.2 2.6-7.5 |
1.8 1.4-3.3 |
||
| Placebo | Geomean 95% CI |
50.0 ND |
50.0 ND |
50.0 ND |
50.0 ND |
50.0 ND |
51.9 47.1-58.2 |
|
| GMFR 95% CI |
ND ND |
1.0 ND |
1.0 ND |
1.0 ND |
1.0 ND |
1.0 0.9-1.2 |
||
| Anti-GII.4 | rNV-2v/50 | Geomean 95% CI |
115.4 94.6-200.5 |
1360.3 1088.6-3343.8 |
904.6 786.9-1497.1 |
744.6 652.8-1023.0 |
472.0 396.7-715.2 |
362.2 317.9-602.6 |
| GMFR 95% CI |
ND ND |
11.8 9.5-40.8 |
7.8 6.7-17.0 |
6.5 5.7-11.4 |
4.1 3.4-6.7 |
3.1 2.7-5.4 |
||
| rNV-2v/150 | Geomean 95% CI |
121.3 96.8-260.6 |
2764.5 2432.6-4731.0 |
871.4 844.9-1520.7 |
703.4 657.3-1099.8 |
408.5 233.5-1186.8 |
286.2 262.0-637.1 |
|
| GMFR 95% CI |
ND ND |
22.8 16.7-62.8 |
7.2 5.3-16.4 |
5.8 4.7-10.1 |
3.4 2.8-5.8 |
2.4 1.9-3.6 |
||
| Placebo | Geomean 95% CI |
102.4 84.5-177.7 |
107.5 55.2-273.1 |
101.5 76.0-196.0 |
104.9 83.8-187.6 |
113.6 96.8-203. |
114.2 94.2-225.4 |
|
| GMFR 95% CI |
ND ND |
1.0 0.9-1.3 |
1.0 0.9-1.1 |
1.0 1.0-1.1 |
1.1 1.0-1.4 |
1.2 1.0-1.5 |
||
CI, confidence interval; Geomean, geometric mean antibody titre; GMFR, geometric mean fold-rise of the specific timepoint versus geomean at day 1 (= pre-vaccination); ND, not determined.
*Geometric mean values are expressed as half maximal inhibitory concentration/titer (IC50).