Table 2. Solicited local and systemic AEs by worst severity grade by dose; full analysis set.
Grade | Ad26.F | MVA | MVAa | Ad26.Z | Placebo | |
---|---|---|---|---|---|---|
N | - | 48 | 45 | 11 | 15 | 23 |
Local AEs | ||||||
Any event, n (%) | Any | 38 (79.2) | 40 (88.9) | 5 (45.5) | 13 (86.7) | 4 (17.4) |
Grade 3 | 2 (4.2) | 0 | 0 | 2 (13.3) | 0 | |
Erythema/ Redness | Any | 5 (10.4) | 0 | 0 | 0 | 0 |
Grade 3 | 1 (2.1) | 0 | 0 | 0 | 0 | |
Itching | Any | 8 (16.7) | 4 (8.9) | 1 (9.1) | 1 (6.7) | 0 |
Grade 3 | 0 | 0 | 0 | 0 | 0 | |
Pain/Tenderness | Any | 38 (79.2) | 40 (88.9) | 4 (36.4) | 13 (86.7) | 4 (17.4) |
Grade 3 | 2 (4.2) | 0 | 0 | 2 (13.3) | 0 | |
Swelling/ Induration | Any | 11 (22.9) | 12 (26.7) | 0 | 3 (20) | 1 (4.3) |
Grade 3 | 0 | 0 | 0 | 1 (6.7) | 0 | |
Warmth | Any | 14 (29.2) | 10 (22.2) | 1 (9.1) | 4 (26.7) | 1 (4.3) |
Grade 3 | 0 | 0 | 0 | 1 (6.7) | 0 | |
Systemic AEs | ||||||
Any event, n (%) | Any | 43 (89.6) | 28 (62.2) | 4 (36.4) | 12 (80) | 13 (56.5) |
Grade 3 | 11 (22.9) | 0 | 1 (9.1) | 3 (20) | 1 (4.3) | |
Arthralgia | Any | 22 (45.8) | 2 (4.4) | 1 (9.1) | 4 (26.7) | 1 (4.3) |
Grade 3 | 2 (4.2) | 0 | 0 | 1 (6.7) | 0 | |
Chills | Any | 31 (64.6) | 4 (8.9) | 0 | 7 (46.7) | 0 |
Grade 3 | 6 (12.5) | 0 | 0 | 2 (13.3) | 0 | |
Fatigue | Any | 36 (75) | 20 (44.4) | 3 (27.3) | 9 (60) | 6 (26.1) |
Grade 3 | 3 (6.3) | 0 | 1 (9.1) | 2 (13.3) | 0 | |
General itching | Any | 5 (10.4) | 3 (6.7) | 1 (9.1) | 1 (6.7) | 1 (4.3) |
Grade 3 | 0 | 0 | 0 | 0 | 0 | |
Headache | Any | 38 (79.2) | 14 (31.1) | 1 (9.1) | 9 (60) | 7 (30.4) |
Grade 3 | 6 (12.5) | 0 | 0 | 3 (20) | 0 | |
Myalgia | Any | 28 (58.3) | 6 (13.3) | 2 (18.2) | 6 (40) | 1 (4.3) |
Grade 3 | 5 (10.4) | 0 | 0 | 2 (13.3) | 0 | |
Nausea | Any | 20 (41.7) | 4 (8.9) | 0 | 1 (6.7) | 4 (17.4) |
Grade 3 | 1 (2.1) | 0 | 0 | 1 (6.7) | 1 (4.3) | |
Pyrexia | Any | 10 (20.8) | 1 (2.2) | 0 | 2 (13.3) | 0 |
Grade 3 | 1 (2.1) | 0 | 0 | 0 | 0 | |
Rash | Any | 0 | 1 (2.2) | 1 (9.1) | 0 | 0 |
Grade 3 | 0 | 0 | 0 | 0 | 0 | |
Vomiting | Any | 5 (10.4) | 1 (2.2) | 0 | 0 | 2 (8.7) |
Grade 3 | 1 (2.1) | 0 | 0 | 0 | 0 |
Ad26.F = Ad26.Filo; Ad26.Z = Ad26.ZEBOV; AEs = adverse events; Inf U = infectious units; MVA = MVA-BN-Filo; n (%) = number (percentage) of doses with one or more events.
a MVA-BN-Filo at a dose of 1x108 Inf U.