Table 7.
Rates of solicited systemic 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 systemic AE, n (%) | 73 (77.7) | 66 (70.2) | 73 (77.7) | 20 (42.6) | 83 (55.3) | 74 (49.3) | 53 (35.3) | 25 (33.3) |
| Severity grade 1 | 40 (42.6) | 32 (34.0) | 43 (45.7) | 18 (38.3) | 52 (34.7) | 53 (35.3) | 45 (30.0) | 20 (26.7) |
| Severity grade 2 | 29 (30.9) | 29 (30.9) | 26 (27.7) | 2 (4.3) | 26 (17.3) | 19 (12.7) | 6 (4.0) | 4 (5.3) |
| Severity grade 3 | 4 (4.3) | 5 (5.3) | 4 (4.3) | 0 | 5 (3.3) | 2 (1.3) | 2 (1.3) | 1 (1.3) |
| Arthralgia | 33 (35.1) | 23 (24.5) | 29 (30.9) | 1 (2.1) | 30 (20.0) | 17 (11.3) | 9 (6.0) | 2 (2.7) |
| Chills | 39 (41.5) | 27 (28.7) | 32 (34.0) | 1 (2.1) | 31 (20.7) | 12 (8.0) | 6 (4.0) | 2 (2.7) |
| Fatigue | 50 (53.2) | 47 (50.0) | 55 (58.5) | 14 (29.8) | 60 (40.0) | 51 (34.0) | 25 (16.7) | 15 (20.0) |
| Headache | 48 (51.1) | 39 (41.5) | 56 (59.6) | 10 (21.3) | 49 (32.7) | 39 (26.0) | 26 (17.3) | 9 (12.0) |
| Myalgia | 50 (53.2) | 48 (51.1) | 47 (50.0) | 7 (14.9) | 45 (30.0) | 31 (20.7) | 25 (16.7) | 5 (6.7) |
| Nausea | 18 (19.1) | 16 (17.0) | 18 (19.1) | 5 (10.6) | 8 (5.3) | 13 (8.7) | 5 (3.3) | 5 (6.7) |
| Pyrexia | 12 (12.8) | 14 (14.9) | 13 (13.8) | 0 | 8 (5.3) | 4 (2.7) | 4 (2.7) | 3 (4.0) |
| Post-dose 2 (MVA-BN-Filo or placebo), N = | 88 | 91 | 91 | 45 | 145 | 143 | 144 | 72 |
| Any systemic AE, n (%) | 40 (45.5) | 35 (38.5) | 45 (49.5) | 11 (24.4) | 43 (29.7) | 46 (32.2) | 56 (38.9) | 16 (22.2) |
| Severity grade 1 | 27 (30.7) | 25 (27.5) | 30 (33.0) | 10 (22.2) | 33 (22.8) | 36 (25.2) | 44 (30.6) | 10 (13.9) |
| Severity grade 2 | 11 (12.5) | 9 (9.9) | 12 (13.2) | 1 (2.2) | 9 (6.2) | 7 (4.9) | 9 (6.3) | 5 (6.9) |
| Severity grade 3 | 2 (2.3) | 1 (1.1) | 3 (3.3) | 0 | 1 (0.7) | 3 (2.1) | 3 (2.1) | 1 (1.4) |
| Arthralgia | 12 (13.6) | 7 (7.7) | 11 (12.1) | 0 | 4 (2.8) | 9 (6.3) | 11 (7.6) | 1 (1.4) |
| Chills | 7 (8.0) | 5 (5.5) | 8 (8.8) | 0 | 3 (2.1) | 7 (4.9) | 3 (2.1) | 4 (5.6) |
| Fatigue | 18 (20.5) | 20 (22.0) | 27 (29.7) | 3 (6.7) | 18 (12.4) | 24 (16.8) | 21 (14.6) | 11 (15.3) |
| Headache | 18 (20.5) | 16 (17.6) | 20 (22.0) | 5 (11.1) | 13 (9.0) | 19 (13.3) | 16 (11.1) | 7 (9.7) |
| Myalgia | 29 (33.0) | 25 (27.5) | 30 (33.0) | 0 | 23 (15.9) | 23 (16.1) | 31 (21.5) | 5 (6.9) |
| Nausea | 4 (4.5) | 3 (3.3) | 4 (4.4) | 3 (6.7) | 5 (3.4) | 8 (5.6) | 2 (1.4) | 4 (5.6) |
| Pyrexia | 3 (3.4) | 3 (3.3) | 7 (7.7) | 4 (8.9) | 5 (3.4) | 5 (3.5) | 5 (3.5) | 5 (6.9) |
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.