Table 2.
Local and systemic adverse reactions after one, two, and three vaccinations in the first randomised dose expansion cohort
|
Placebo group day 0 injection (n=5) |
Placebo group day 28 injection (n=5) |
Low-dose COH04S1 plus placebo group day 0 injection (n=14) |
Low-dose COH04S1 plus placebo group day 28 injection (n=13) |
Low-dose COH04S1 plus placebo group day 56 injection (n=10) |
Low-dose COH04S1 group day 0 injection (n=14) |
Low-dose COH04S1 group day 28 injection (n=13) |
|||
|---|---|---|---|---|---|---|---|---|---|
| Grade 1 | Grade 1 | Grade 1 | Grade 3 | Grade 1 | Grade 1 | Grade 1 | Grade 2 | Grade 1 | |
| Injection site reaction | 2 (40%) | 2 (40%) | 8 (57%) | 0 | 3 (23%) | 9 (90%) | 5 (36%) | 0 | 7 (54%) |
| Fatigue | 1 (20%) | 0 | 4 (29%) | 0 | 4 (31%) | 6 (60%) | 7 (50%) | 0 | 5 (38%) |
| Headache | 1 (20%) | 2 (40%) | 2 (14%) | 0 | 2 (15%) | 5 (50%) | 5 (36%) | 0 | 4 (31%) |
| Myalgia | 0 | 1 (20%) | 2 (14%) | 0 | 0 | 2 (20%) | 3 (21%) | 0 | 5 (38%) |
| Chills | 0 | 1 (20%) | 3 (21%) | 0 | 2 (15%) | 3 (30%) | 1 (7%) | 0 | 0 |
| Insomnia | 0 | 1 (20%) | 0 | 0 | 0 | 1 (10%) | 1 (7%) | 0 | 0 |
| Nausea | 0 | 1 (20%) | 0 | 0 | 0 | 1 (10%) | 1 (7%) | 0 | 0 |
| Sore throat | 0 | 0 | 1 (7%) | 0 | 0 | 0 | 1 (7%) | 0 | 1 (8%) |
| Cough | 0 | 0 | 1 (7%) | 0 | 0 | 0 | 0 | 0 | 1 (8%) |
| Bilateral hand swelling | 0 | 0 | 0 | 0 | 0 | 1 (10%) | 0 | 0 | 0 |
| Blood bilirubin increased | 0 | 0 | 0 | 0 | 1 (8%) | 0 | 0 | 0 | 0 |
| Creatinine increased | 0 | 0 | 0 | 0 | 0 | 0 | 1 (7%) | 0 | 0 |
| Diarrhoea | 0 | 0 | 1 (7%) | 0 | 0 | 0 | 0 | 0 | 0 |
| Fever | 0 | 0 | 0 | 1 (7%) | 0 | 0 | 0 | 0 | 0 |
| Hypocalcaemia | 1 (20%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hypokalaemia | 0 | 0 | 1 (7%) | 0 | 0 | 0 | 0 | 0 | 0 |
| Lymph node adenopathy | 0 | 1 (20%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Malaise | 0 | 0 | 0 | 0 | 0 | 0 | 1 (7%) | 0 | 0 |
| Nasal congestion | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (8%) |
| Vomiting | 0 | 0 | 0 | 0 | 0 | 0 | 1 (7%) | 0 | 0 |
| Idiopathic iritis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (7%) | 0 |
| Tender breasts | 0 | 0 | 0 | 0 | 0 | 1 (10%) | 0 | 0 | 0 |
Grade 2 idiopathic iritis was unrelated to treatment. Grade 3 fever was a moderate toxicity that lasted 1 day, and became grade 1, which also lasted 1 day.