Table 2.
EBOV-specific binding antibodies (ELISA U/mL) GMCs and responder rates (%) in both studiesa.
| Study 1: Group 1 [Leiden WVS] | Study 1: Group 2 [Bern WVS] | Study 1: Group 3 [Leiden MVSb] | Study 2: Group 1 [Full clinical dose] | Study 2: Group 2 [Intermediate dose] | Study 2: Group 3 [Low dose] | |
|---|---|---|---|---|---|---|
| Day 1 (Baseline), N = | 85 | 86 | 87 | 140 | 131 | 136 |
| GMC, EU/mL (95% CI) | <LLOQ (<LLOQ–LLOQ) | <LLOQ (<LLOQ–<LLOQ) | <LLOQ (<LLOQ–<LLOQ) | <LLOQ (<LLOQ–<LLOQ) | <LLOQ (<LLOQ–<LLOQ) | <LLOQ (<LLOQ–<LLOQ) |
| Day 57 (56 days post-dose 1), N = | 85 | 88 | 88 | 140 | 131 | 136 |
| GMC, EU/mL (95% CI) | 813 (632–1046) | 745 (603–921) | 851 (720–1006) | 793 (698–902) | 669 (571–784) | 496 (422–582) |
| Responders, n/Nc (%) | 82/85 (96.5) | 83/86 (96.5) | 87/87 (100) | 135/140 (96.4) | 127/131 (96.9) | 131/136 (96.3) |
| Day 78 (21 days post-dose 2), N = | 81 | 87 | 86 | 135 | 123 | 130 |
| GMC, EU/mL (95% CI) | 11,089 (9323–13,189) | 10,337 (8660–12,339) | 11,790 (9701–14,328) | 11,054 (9673–12,633) | 7524 (6472–8746) | 8538 (7338–9934) |
| Responders, n/Nc (%) | 81/81 (100) | 85/85 (100) | 85/85 (100) | 135/135 (100) | 123/123 (100) | 130/130 (100) |
| Day 237 (180 days post-dose 2), N = | 82 | 82 | 80 | 131 | 121 | 129 |
| GMC, EU/mL (95% CI) | 1262 (1029–1549) | 1053 (846–1310) | 1147 (948–1387) | 1263 (1100–1450) | 962 (822–1125) | 831 (716–965) |
| Responders, n/Nc (%) | 80/82 (97.6) | 78/80 (97.5) | 78/79 (98.7) | 129/131 (98.5) | 119/121 (98.3) | 127/129 (98.4) |
aPlacebo groups (Group 4 in both studies) were lower than the LLOQ throughout.
bSame Leiden MVS batch as used in phase 1/2 studies.
cNumber of participants with data at both baseline and at that time point.
CI: confidence interval; EBOV: Ebola virus; EU: ELISA units; GMC: geometric mean concentration; Inf.U: infectious units; LLOQ: lower limit of quantification; MVS: master virus seed; vp: viral particles; WVS: working virus seed.