Table 2.
Adverse reactions within 7 days and overall adverse events within 28 days after the first and the second vaccinations for the group aged 18–59 years in phase 1
|
2 μg cohort (n=32) |
4 μg cohort (n=32) |
8 μg cohort (n=32) |
Total (n=96) |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Vaccination (n=24) | Placebo (n=8) | p value | Vaccination (n=24) | Placebo (n=8) | p value | Vaccination (n=24) | Placebo (n=8) | p value | Vaccination (n=72) | Placebo (n=24) | p value | ||
| All adverse reactions within 0–7 days | |||||||||||||
| Any | 11 (46%) | 3 (38%) | >0·99 | 8 (33%) | 2 (25%) | >0·99 | 11 (46%) | 1 (13%) | 0·20 | 30 (42%) | 6 (25%) | 0·22 | |
| Grade 1 | 10 (42%) | 3 (38%) | .. | 8 (33%) | 2 (25%) | .. | 11 (46%) | 1 (13%) | .. | 29 (40%) | 6 (25%) | .. | |
| Grade 2 | 1 (4%) | 0 | .. | 0 | 0 | .. | 1 (4%) | 0 | .. | 2 (3%) | 0 | .. | |
| Injection site adverse reactions within 0–7 days | |||||||||||||
| Pain | 9 (38%) | 1 (13%) | 0·38 | 7 (29%) | 1 (13%) | 0·64 | 9 (38%) | 0 | 0·07 | 25 (35%) | 2 (8%) | 0·017 | |
| Grade 1 | 9 (38%) | 1 (13%) | .. | 7 (29%) | 1 (13%) | .. | 9 (38%) | .. | .. | 25 (35%) | 2 (8%) | .. | |
| Grade 2 | 0 | 0 | .. | 0 | 0 | .. | 0 | 0 | .. | 0 | 0 | .. | |
| Swelling | 0 | 0 | .. | 0 | 1 (13%) | 0·25 | 2 (8%) | 0 | >0·99 | 2 (3%) | 1 (4%) | >0·99 | |
| Grade 1 | 0 | 0 | .. | 0 | 1 (13%) | .. | 1 (4%) | 0 | .. | 1 (1%) | 1 (4%) | .. | |
| Grade 2 | 0 | 0 | .. | 0 | 0 | .. | 1 (4%) | 0 | .. | 1 (1%) | 0 | ||
| Itch | 0 | 0 | .. | 1 (4%) | 0 | >0·99 | 0 | 0 | .. | 1 (1%) | 0 | >0·99 | |
| Grade 1 | 0 | 0 | .. | 1 (4%) | 0 | .. | 0 | 0 | .. | 1 (1%) | 0 | .. | |
| Grade 2 | 0 | 0 | .. | 0 | 0 | .. | 0 | 0 | .. | 0 | 0 | .. | |
| Redness | 1 (4%) | 0 | >0·99 | 0 | 0 | .. | 0 | 0 | .. | 1 (1%) | 0 | >0·99 | |
| Grade 1 | 1 (4%) | 0 | .. | 0 | 0 | .. | 0 | 0 | .. | 1 (1%) | 0 | .. | |
| Grade 2 | 0 | 0 | .. | 0 | 0 | .. | 0 | 0 | .. | 0 | 0 | .. | |
| Systemic adverse reactions within 0–7 days | |||||||||||||
| Fever | 1 (4%) | 2 (25%) | 0·15 | 1 (4%) | 0 | >0·99 | 2 (8%) | 0 | >0·99 | 4 (6%) | 2 (8%) | 0·64 | |
| Grade 1 | 1 (4%) | 2 (25%) | .. | 1 (4%) | 0 | .. | 2 (8%) | 0 | .. | 4 (6%) | 2 (8%) | .. | |
| Grade 2 | 0 | 0 | .. | 0 | 0 | .. | 0 | 0 | .. | 0 | 0 | .. | |
| Fatigue | 2 (8%) | 0 | >0·99 | 0 | 0 | .. | 0 | 1 (13%) | 0·25 | 2 (3%) | 1 (4%) | >0·99 | |
| Grade 1 | 2 (8%) | 0 | .. | 0 | 0 | .. | 0 | 1 (13%) | .. | 2 (3%) | 1 (4%) | .. | |
| Grade 2 | 0 | 0 | .. | 0 | 0 | .. | 0 | 0 | .. | 0 | 0 | .. | |
| Inappetence | 0 | 0 | .. | 0 | 0 | .. | 1 (4%) | 0 | >0·99 | 1 (1%) | 0 | >0·99 | |
| Grade 1 | 0 | 0 | .. | 0 | 0 | .. | 1 (4%) | 0 | .. | 1 (1%) | 0 | .. | |
| Grade 2 | 0 | 0 | .. | 0 | 0 | .. | 0 | 0 | .. | 0 | 0 | .. | |
| Nausea | 0 | 0 | .. | 0 | 0 | .. | 1 (4%) | 0 | >0·99 | 1 (1%) | 0 | >0·99 | |
| Grade 1 | 0 | 0 | .. | 0 | 0 | .. | 1 (4%) | 0 | .. | 1 (1%) | 0 | .. | |
| Grade 2 | 0 | 0 | .. | 0 | 0 | .. | 0 | 0 | .. | 0 | 0 | .. | |
| Constipation | 0 | 0 | .. | 0 | 0 | .. | 1 (4%) | 0 | >0·99 | 1 (1%) | 0 | >0·99 | |
| Grade 1 | 0 | 0 | .. | 0 | 0 | .. | 1 (4%) | 0 | .. | 1 (1%) | 0 | .. | |
| Grade 2 | 0 | 0 | .. | 0 | 0 | .. | 0 | 0 | .. | 0 | 0 | .. | |
| Mucocutaneous abnormalities | 1 (4%) | 0 | >0·99 | 0 | 0 | .. | 0 | 0 | .. | 1 (1%) | 0 | >0·99 | |
| Grade 1 | 0 | 0 | .. | 0 | 0 | .. | 0 | 0 | .. | 0 | 0 | .. | |
| Grade 2 | 1 (4%) | 0 | .. | 0 | 0 | .. | 0 | 0 | .. | 1 (1%) | 0 | .. | |
| Headache | 1 (4%) | 0 | >0·99 | 0 | 0 | .. | 0 | 0 | .. | 1 (1%) | 0 | >0·99 | |
| Grade 1 | 1 (4%) | 0 | .. | 0 | 0 | .. | 0 | 0 | .. | 1 (1%) | 0 | .. | |
| Grade 2 | 0 | 0 | .. | 0 | 0 | .. | 0 | 0 | .. | 0 | 0 | .. | |
| Vomiting | 0 | 0 | .. | 1 (4%) | 0 | >0·99 | 0 | 0 | .. | 1 (1%) | 0 | >0·99 | |
| Grade 1 | 0 | .. | 1 (4%) | 0 | .. | 0 | 0 | .. | 1 (1%) | 0 | .. | ||
| Grade 2 | 0 | 0 | .. | 0 | 0 | .. | 0 | 0 | .. | 0 | 0 | .. | |
| Itch (non-injection site) | 1 (4%) | 0 | >0·99 | 0 | 0 | 0 | 0 | .. | 1 (1%) | 0 | >0·99 | ||
| Grade 1 | 1 (4%) | 0 | .. | .. | 0 | .. | 0 | 0 | .. | 1 (1%) | 0 | .. | |
| Grade 2 | 0 | 0 | .. | .. | 0 | .. | 0 | 0 | .. | 0 | 0 | .. | |
| Overall adverse events within 0–28 days | |||||||||||||
| Any | 12 (50%) | 3 (38%) | 0·69 | 11 (46%) | 2 (25%) | 0·42 | 11 (46%) | 2 (25%) | 0·42 | 34 (47%) | 7 (29%) | 0·16 | |
| Grade 1 | 10 (42%) | 3 (38%) | .. | 8 (33%) | 1 (13%) | .. | 8 (33%) | 1 (8%) | .. | 26 (36%) | 5 (21%) | .. | |
| Grade 2 | 2 (8%) | 0 | .. | 3 (13%) | 1 (13%) | .. | 3 (13%) | 1 (8%) | .. | 8 (11%) | 2 (8%) | .. | |
Data are n (%). Any refers to all the participants with any grade adverse reactions or events. Adverse reactions and events were graded according to the scale issued by the China State Food and Drug Administration.