Table 1 Safety evaluations—related adverse events
Finding | ID93 | |||||
|---|---|---|---|---|---|---|
2 µg | 2 µg | 2 µg | 10 µg | 10 µg | 10 µg | |
GLA-SE | ||||||
– | 2 µg | 5 µg | – | 2 µg | 5 µg | |
n = 6 | n = 12 | n = 12 | n = 6 | n = 12 | n = 12 | |
Subjects with at least one related AE | 3 (50%) | 12 (100%) | 10 (83%) | 2 (33%) | 12 (100%) | 10 (83%) |
Local solicited adverse events | ||||||
Injection site erythema | 0 | 2 (17%) | 0 | 0 | 0 | 0 |
Injection site pain | 2 (33%) | 11 (92%) | 10 (83%) | 1 (17%) | 12 (100%) | 10 (83%) |
Injection site swelling | 0 | 1 (8%) | 1 (8%) | 0 | 1 (8%) | 0 |
Systemic solicited adverse events | ||||||
Arthralgia | 0 | 0 | 1 (8%) | 0 | 0 | 1 (8%) |
Chills | 0 | 2 (17%) | 0 | 0 | 0 | 0 |
Decreased appetite | 0 | 2 (17%) | 1 (8%) | 0 | 0 | 0 |
Fatigue | 1 (17%) | 4 (33%) | 3 (25%) | 0 | 1 (8%) | 4 (33%) |
Headache | 2 (33%) | 3 (25%) | 3 (25%) | 1 (17%) | 2 (17%) | 3 (25%) |
Myalgia | 0 | 2 (17%) | 1 (8%) | 0 | 0 | 2 (17%) |
All other related AEs occurring in at least two subjects | ||||||
Aspartate aminotransferase increased | 0 | 0 | 0 | 0 | 2 (17%) | 0 |
