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.