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. 2021 Aug 19;21(12):1725–1736. doi: 10.1016/S1473-3099(21)00153-5

Table 2.

Severity of treatment-related adverse events in the challenge study

Vaccine group (n=10)
Placebo group (n=5)
p value
Mild Moderate Severe Adverse event index Mild Moderate Severe Adverse event index
Vaccine stage 1 and 2
All treatment-related adverse events 63 11 0 4·5 (3·0–5·0) 13 3 0 1·0 (1·0–2·0) 0·0064
Dermal reactions 53 11 0 3·0 (2·5–5·0) 8 1 0 1·0 (1·0–2·0) 0·00084
Induration or erythema 19 1 0 1·0 (1·0–2·0) 5 1 0 1·0 (1·0–1·0) 0·32
Other dermal 34 10 0 2·0 (2·0–3·0) 3 0 0 1·0 (1·0–1·0) 0·010
Gastrointestinal symptoms 7 0 0 1·0 (1·0–2·0) 5 2 0 2·0 (1·0–3·5) 0·42
Respiratory reactions 0 0 0 .. 0 0 0 .. ..
Other 3 0 0 1·0 (1·0–1·0) 0 0 0 .. ..
Challenge stage
All treatment-related adverse events 47 8 1 5·5 (5·0–7·0) 19 2 0 4·0 (3·0–5·0) 0·090
Dermal reactions 30 6 1 4·0 (4·0–5·0) 6 2 0 2·0 (2·0–2·0) 0·0026
Induration or erythema 13 3 1 2·0 (2·0–3·0) 2 0 0 1·0 (1·0–1·0) 0·37
Other dermal 17 3 0 2·0 (1·0–3·0) 4 2 0 2·0 (1·0–2·0) 0·27
Gastrointestinal symptoms 7 2 0 1·5 (1·0–2·0) 6 0 0 3·0 (1·0–5·0) 0·59
Respiratory reactions 0 0 0 .. 2 0 0 2·0 (NA) ..
Other 10 0 0 1·0 (1·0–1·0) 5 0 0 1·0 (1·0–1·0) ..

Data are number of events and median (IQR). NA=not applicable.