Event
|
ACC-001 + QS-21
|
ACC-001
|
QS-21 (n = 6)
|
PBS (n = 4)
|
---|
|
3 μg (n = 6)
|
10 μg (n = 6)
|
30 μg (n = 6)
|
10 μg (n = 6)
|
30 μg (n = 6)
| | |
---|
Any serious adverse eventa
|
1 (16.7)
|
0
|
1 (16.7)
|
0
|
0
|
0
|
0
|
Any adverse events
|
6 (100.0)
|
4 (66.7)
|
5 (83.3)
|
6 (100.0)
|
6 (100.0)
|
6 (100.0)
|
3 (75.0)
|
Nasopharyngitis
|
2 (33.3)
|
2 (33.3)
|
2 (33.3)
|
0
|
3 (50.0)
|
1 (16.7)
|
2 (50.0)
|
Injection site erythema
|
0
|
2 (33.3)
|
0
|
0
|
1 (16.7)
|
0
|
0
|
Dental caries
|
0
|
1 (16.7)
|
0
|
1 (16.7)
|
1 (16.7)
|
0
|
1 (25.0)
|
Protein urine present
|
1 (16.7)
|
1 (16.7)
|
0
|
0
|
1 (16.7)
|
0
|
0
|
Glucose urine
|
1 (16.7)
|
0
|
0
|
1 (16.7)
|
0
|
0
|
1 (25.0)
|
Cataract
|
1 (16.7)
|
0
|
0
|
1 (16.7)
|
0
|
0
|
1 (25.0)
|
Contusion
|
1 (16.7)
|
0
|
0
|
1 (16.7)
|
0
|
1 (16.7)
|
0
|
Back pain
|
0
|
0
|
1 (16.7)
|
0
|
1 (16.7)
|
0
|
0
|
Blood triglyceride increased
|
0
|
1 (16.7)
|
1 (16.7)
|
0
|
0
|
1 (16.7)
|
0
|
Injection site pain
|
0
|
1 (16.7)
|
1 (16.7)
|
0
|
0
|
0
|
0
|
Pyrexia
|
0
|
1 (16.7)
|
0
|
0
|
1 (16.7)
|
0
|
0
|
Delirium
|
1 (16.7)
|
0
|
0
|
0
|
0
|
1 (16.7)
|
0
|
Blood pressure increased
|
0
|
0
|
0
|
1 (16.7)
|
0
|
1 (16.7)
|
0
|
Eczema
|
0
|
1 (16.7)
|
0
|
0
|
0
|
0
|
1 (25.0)
|
- Data presented as n (%). PBS, phosphate-buffered saline. aAll patients.