Table 2.
Ebola glycoprotein-specific antibody concentrations (in log10 ELISA units/mL) in each trial from 7 days after the second vaccination to study completion.
| Phase I trials | Phase II trials | |||||
|---|---|---|---|---|---|---|
| EBL1001 | EBL1003 | EBL1004 | EBL2001 | EBL2002 | EBL3001 | |
| (n = 14)a | (n = 15)a | (n = 15)a | (n = 71)a | (n = 137)b | (n = 235)c | |
| Day 64 (7 days after the 2nd vaccination, MVA-BN-Filo) | ||||||
| Number Part. | 14 | 15 | 15 | |||
| Positive Part.d | 14 (100%) | 15 (100%) | 15 (100%) | |||
| Missing data | 0 (0%) | 0 (0%) | 0 (0%) | |||
| Mean [IQR] | 3.19 [2.99; 3.48] | 3.33 [2.90; 3.73] | 3.09 [2.55; 3.58] | |||
| Day 78 (21 days after the 2nd vaccination, MVA-BN-Filo) | ||||||
| Number Part. | 14 | 15 | 15 | 70 | 137 | 231 |
| Positive Part.d | 14 (100%) | 15 (100%) | 15 (100%) | 70 (100%) | 137 (100%) | 231 (100%) |
| Missing data | 0 (0%) | 0 (0%) | 0 (0%) | 1 (1%) | 0 (0%) | 4 (2%) |
| Mean [IQR] | 3.88 [3.64; 4.10] | 4.21 [3.96; 4.45] | 4.03 [3.80; 4.31] | 4.00 [3.79; 4.43] | 3.88 [3.62; 4.16] | 3.60 [3.34; 3.88] |
| Day 156 (155 days after the 1st vaccination, Ad26.ZEBOV) | ||||||
| Number Part. | 42e | |||||
| Positive Part.d | 42 (100%) | |||||
| Missing data | 1 (2%) | |||||
| Mean [IQR] | 2.73 [2.54; 3.00] | |||||
| Day 180 (179 days after the 1st vaccination, Ad26.ZEBOV) | ||||||
| Number Part. | 12 | 15 | 15 | 23f | ||
| Positive Part.d | 12 (100%) | 15 (100%) | 15 (100%) | 23 (100%) | ||
| Missing data | 2 (14%) | 0 (0%) | 0 (0%) | |||
| Mean [IQR] | 3.47 [3.29; 3.60] | 3.00 [2.67; 3.20] | 2.97 [2.71; 3.25] | 2.70 [2.47; 2.85] | ||
| Day 240 (239 days after the 1st vaccination, Ad26.ZEBOV) | ||||||
| Number Part. | 13 | 15 | 15 | |||
| Positive Part.d | 13 (100%) | 15 (100%) | 15 (100%) | |||
| Missing data | 1 (7%) | 0 (0%) | 0 (0%) | |||
| Mean [IQR] | 3.35 [3.20; 3.41] | 2.66 [2.22; 2.93] | 2.83 [2.56; 3.09] | |||
| Day 360/365 (1 year after the 1st vaccination, Ad26.ZEBOV) | ||||||
| Number Part. | 12 | 15 | 15 | 51 | 134 | 207 |
| Positive Part.d | 12 (100%) | 15 (100%) | 15 (100%) | 51 (100%) | 134 (100%) | 205 (99%) |
| Missing data | 2 (14%) | 0 (0%) | 0 (0%) | 20 (28%) | 3 (2%) | 28 (12%) |
| Mean [IQR] | 3.24 [3.09; 3.33] | 2.61 [2.40; 2.96] | 2.74 [2.46; 3.06] | 3.07 [2.89; 3.28] | 2.54 [2.26; 2.78] | 2.44 [2.11; 2.68] |
| Day 540 (539 days after the 1st vaccination, Ad26.ZEBOV) | ||||||
| Number Part. | 33e | |||||
| Positive Part.d | 33 (100%) | |||||
| Missing data | 10 (23%) | |||||
| Mean [IQR] | 2.43 [2.15; 2.68] | |||||
| Day 720 (2 years after the 1st vaccination, Ad26.ZEBOV) | ||||||
| Number Part. | 190 | |||||
| Positive Part.d | 184 (97%) | |||||
| Missing data | 45 (19 %) | |||||
| Mean [IQR] | 2.45 [2.19; 2.69] | |||||
IQR: Interquartile range = 75% confidence intervals, Part.: Participants.
aParticipants receiving the 2nd vaccination in the protocol-defined window of 57 ± 1 day.
bParticipants receiving the 2nd vaccination in the protocol-defined window of 57 ± 3 days.
cParticipants receiving the 2nd vaccination in the protocol-defined window of 57 ± 1 week.
dRefers to the number of participants with antibody concentration above the lower limit of quantification (LLOQ), expressed as n/N (%) where n is the number of participants with a concentration above the LLOQ (i.e., 36.11 EU/mL for Battelle lab, 26.22 EU/mL for Focus lab and 36.11 EU/mL for Q2 Solutions lab) at that timepoint and N is the total number of participants with data at the first and the second vaccination and at that time point.
eRefers only to 43 participants enrolled in a substudy to receive a third dose (Ad26.ZEBOV) 2 years after the first vaccination.
fRefers to participants enrolled in EBL 2002 having an additional timepoint, initially scheduled for participants who do not receive a second vaccination because of a study pause.