Table 4. Anti-SE36 antibody titers pre-vaccination (baseline) and 21 days post-second vaccination in Stage1.
ELISA titer | Change from | |||||
Geometric mean [95% CI] | baseline | |||||
Seroconversion | Gender | Vaccine | Statistic | Baseline | 21 days after 2nd vaccination | p value |
Negative | Male | BKSE1.0 | FAS n | 9 | 9 | FAS: |
GM | 35.90 [22.73; 56.70] | 59.05 [44.84; 77.77] | Within BKSE1.0 = 0.004 | |||
PPS n | 7 | 7 | ||||
GM | 34.26 [18.33; 64.03] | 56.02 [40.35; 77.77] | Between BKSE1.0 vs. | |||
Saline | FAS n | 5 | 5 | Saline = 0.02 | ||
GM | 24.35 [13.67; 43.35] | 29.79 [9.00; 98.62] | ||||
PPS n | 4 | 4 | PPS: | |||
GM | 21.07 [11.41; 38.91] | 19.66 [12.28; 31.47] | Within BKSE1.0 = 0.04 | |||
Female | BKSE1.0 | FAS n | 9 | 9 | ||
GM | 22.04 [12.08; 40.19] | 34.48 [21.66; 54.87] | Between BKSE1.0 vs. | |||
PPS n | 6 | 6 | Saline = 0.014 | |||
GM | 29.41 [13.13; 65.85] | 44.45 [26.84; 73.61] | ||||
Saline | FAS/PPS n | 5 | 4 | |||
GM | 36.80 [8.75; 154.74] | 26.32 [4.46; 155.30] | ||||
Positive | Male | BKSE1.0 | FAS n | 9 | 9 | FAS: |
GM | 465.40 [207.70;1042.87] | 403.87 [205.73; 792.81] | Within BKSE1.0 = 0.39 | |||
PPS n | 6 | 6 | ||||
GM | 511.44 [160.85;1626.15] | 418.59 [170.79;1025.91] | Between BKSE1.0 vs. | |||
Saline | FAS/PPS n | 5 | 5 | Saline = 0.47 | ||
GM | 237.52 [142.75; 395.19] | 333.08 [145.9; 760.40] | ||||
Female | BKSE1.0 | FAS n | 9 | 9 | PPS: | |
GM | 469.32 [260.81; 844.52] | 496.68 [254.68; 968.65] | Within BKSE1.0 = 0.11 | |||
PPS n | 7 | 7 | ||||
GM | 521.47 [257.93;1054.29] | 460.62 [206.87;1025.62] | Between BKSE1.0 vs. | |||
Saline | FAS/PPS n | 5 | 5 | Saline = 0.19 | ||
GM | 495.74 [114.01; 2155.55] | 340.44 [67.66; 1713.09] |
Statistic is presented either as immunogenicity full analysis set (FAS) or per-protocol set (PPS); n = number of subjects; GM = geometric mean; CI = confidence interval of geometric mean; For additional information on PPS, refer to Text S1. p values are based on analysis within treatment group (Signed Rank), and between treatment groups (Wilcoxon Rank Sums).