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. 2022 Oct 5;17(10):e0274906. doi: 10.1371/journal.pone.0274906

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.