TABLE 1

IgA ASC responses to GI.1 and GII.4 VLPs

Treatment groupNo. of participantsDayGI.1GII.4
Geometric meana (95% CIb)Geometric mean fold rise (95% CI)% with 4-fold rise (95% CI)Geometric mean (95% CI)Geometric mean fold rise (95% CI)% with 4-fold rise (95% CI)
Placebo808 8
8715 (4, 59)1.8 (0.4, 7.4)12.5 (0.3, 52.7)20 (2, 163)2.4 (0.3, 20.3)12.5 (0.3, 52.7)
82881.00.0 (0.0, 36.9)81.00.0 (0.0, 36.9)
7359 (7, 11)1.1 (0.9, 1.4)0.0 (0.0, 41.0)11 (5, 23)1.4 (0.6, 2.9)14.3 (0.4, 57.9)
5/5 μg1008 8
1079,545 (5,039, 18,077)1,193 (629.9, 2,260)100.0 (69.2, 100.0)2,170 (863, 5,458)271.2 (107.8, 682.2)100.0 (69.2, 100.0)
9289 (7, 11)1.1 (0.9, 1.4)0.0 (0.0, 33.6)9 (7, 11)1.1 (0.9, 1.3)0.0 (0.0, 33.6)
93546 (18, 121)5.8 (2.2, 15.1)55.6 (21.2, 86.3)126 (37, 429)15.7 (4.6, 53.7)77.8 (40.0, 97.2)
15/15 μg908 8
973,367 (968, 11,705)420.9 (121.1, 1,463)100.0 (66.4, 100.0)886 (381, 2,057)110.7 (47.7, 257.1)100.0 (66.4, 100.0)
82812 (6, 21)1.5 (0.8, 2.7)12.5 (0.3, 52.7)10 (6, 15)1.2 (0.8, 1.9)12.5 (0.3, 52.7)
73532 (13, 79)4.0 (1.6, 9.9)14.3 (0.4, 57.9)46 (9, 244)5.8 (1.1, 30.5)57.1 (18.4, 90.1)
50/50 μg909 (7, 10) 8
979,262 (2,285, 37,541)1,072 (243.7, 4,714)100.0 (66.4, 100.0)2,806 (569, 13,825)350.7 (71.2, 1,728)100.0 (66.4, 100.0)
82819 (8, 41)2.1 (1.0, 4.4)25.0 (3.2, 65.1)81.00.0 (0.0, 36.9)
83530 (13, 67)3.4 (1.5, 8.0)37.5 (8.5, 75.5)26 (12, 56)3.2 (1.5, 7.0)50.0 (15.7, 84.3)
150/150 μg608 8
6736,303 (12,580, 104,758)4,538 (1,573, 13,095)100.0 (54.1, 100.0)15,374 (3,360, 70,336)1,922 (420.0, 8,792)100.0 (54.1, 100.0)
62818 (6, 56)2.2 (0.7, 7.0)16.7 (0.4, 64.1)27 (10, 68)3.3 (1.3, 8.5)16.7 (0.4, 64.1)
53590 (32, 252)11.2 (4.0, 31.4)100.0 (47.8, 100.0)327 (128, 836)40.9 (16.0, 104.4)100.0 (47.8, 100.0)
  • a The geometric mean number of ASCs per million PBMCs is given for each study group.

  • b CI, confidence interval.