Table 6.
Rates of solicited local adverse events after each dose in the respective groups of the two studies, n (%).
| Study 1: Group 1 [Leiden WVS] | Study 1: Group 2 [Bern WVS] | Study 1: Group 3 [Leiden MVSa] | Study 1: Group 4 [Placebo] | Study 2: Group 1 [Full clinical dose] | Study 2: Group 2 [Intermediate dose] | Study 2: Group 3 [Low dose] | Study 2: Group 4 [Placebo] | |
|---|---|---|---|---|---|---|---|---|
| Post-dose 1 (Ad26.ZEBOV or placebo), N = | 94 | 94 | 94 | 47 | 150 | 150 | 150 | 75 |
| Any local AE, n (%) | 59 (62.8) | 49 (52.1) | 59 (62.8) | 12 (25.5) | 78 (52.0) | 61 (40.7) | 37 (24.7) | 5 (6.7) |
| Severity grade 1 | 45 (47.9) | 40 (42.6) | 47 (50.0) | 9 (19.1) | 65 (43.3) | 57 (38.0) | 32 (21.3) | 4 (5.3) |
| Severity grade 2 | 14 (14.9) | 8 (8.5) | 11 (11.7) | 3 (6.4) | 12 (8.0) | 4 (2.7) | 5 (3.3) | 1 (1.3) |
| Severity grade 3 | 0 | 1 (1.1) | 1 (1.1) | 0 | 1 (0.7) | 0 | 0 | 0 |
| Erythema | 0 | 1 (1.1) | 2 (2.1) | 2 (4.3) | 0 | 0 | 1 (0.7) | 0 |
| Pain | 57 (60.6) | 49 (52.1) | 58 (61.7) | 10 (21.3) | 73 (48.7) | 58 (38.7) | 28 (18.7) | 3 (4.0) |
| Pruritus | 5 (5.3) | 8 (8.5) | 8 (8.5) | 1 (2.1) | 10 (6.7) | 5 (3.3) | 6 (4.0) | 3 (4.0) |
| Swelling | 16 (17.0) | 8 (8.5) | 5 (5.3) | 2 (4.3) | 13 (8.7) | 4 (2.7) | 10 (6.7) | 1 (1.3) |
| Post-dose 2 (MVA-BN-Filo or placebo), N = | 88 | 91 | 91 | 45 | 145 | 143 | 144 | 72 |
| Any local AE, n (%) | 45 (51.1) | 42 (46.2) | 50 (54.9) | 2 (4.4) | 61 (42.1) | 49 (34.3) | 46 (31.9) | 5 (6.9) |
| Severity grade 1 | 35 (39.8) | 33 (36.3) | 40 (44.0) | 2 (4.4) | 52 (35.9) | 45 (31.5) | 40 (27.8) | 5 (6.9) |
| Severity grade 2 | 8 (9.1) | 8 (8.8) | 10 (11.0) | 0 | 9 (6.2) | 2 (1.4) | 6 (4.2) | 0 |
| Severity grade 3 | 2 (2.3) | 1 (1.1) | 0 | 0 | 0 | 2 (1.4) | 0 | 0 |
| Erythema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Pain | 45 (51.1) | 40 (44.0) | 48 (52.7) | 2 (4.4) | 60 (41.4) | 47 (32.9) | 42 (29.2) | 5 (6.9) |
| Pruritus | 3 (3.4) | 4 (4.4) | 9 (9.9) | 1 (2.2) | 2 (1.4) | 3 (2.1) | 8 (5.6) | 0 |
| Swelling | 7 (8.0) | 5 (5.5) | 9 (9.9) | 1 (2.2) | 6 (4.1) | 6 (4.2) | 5 (3.5) | 1 (1.4) |
Solicited AEs were based on participant-completed diary cards and were reported on the day of injection (post-injection) and for the following seven days.
aSame Leiden MVS batch as used in phase 1/2 studies.
AE: adverse event; MVS: master virus seed; N: number of participants with data at that time point; n (%): number (percentage) of participants with one or more events, where the denominator is the number of participants with available reactogenicity data after the given dose; WVS: working virus seed.