Table 3.
Summary of solicited adverse events post-vaccination (day 0–7) for subjects vaccinated with 50 μg MSP142/AS01
|
Phase 1 US: 50 μg MSP142/AS01 (N = 54#) n(%) | ||||
| |
G1 |
G2 |
G3 |
Any |
|
Pain |
27 (50%) |
17 (31%) |
6 (11%) |
50 (93%) |
|
Redness |
7 (13%) |
5 (9%) |
11 (20%) |
23 (43%) |
|
Swelling |
4 (7%) |
7 (13%) |
24 (44%) |
35 (65%) |
|
Fever |
7 (13%) |
10 (19%) |
3 (6%) |
20 (37%) |
|
Fatigue |
18 (33%) |
14 (26%) |
6 (11%) |
38 (70%) |
|
Nausea |
2 (4%) |
2 (4%) |
1 (2%) |
5 (9%) |
|
Headache |
8 (15%) |
15 (28%) |
5 (9%) |
28 (52%) |
|
Malaise |
11 (20%) |
12 (22%) |
7 (13%) |
30 (56%) |
|
Myalgias |
11 (20%) |
9 (17%) |
6 (11%) |
26 (48%) |
|
Joint Pain |
9 (17%) |
8 (15%) |
3 (6%) |
20 (37%) |
|
Phase 1 Kenya: 50 μg MSP142/AS01 (N = 59#) n(%) | ||||
| |
G1 |
G2 |
G3 |
Any |
|
Pain |
36 (61%) |
17 (29%) |
0 (0%) |
53 (90%) |
|
Redness |
4 (7%) |
0 (0%) |
1 (2%) |
5 (8%) |
|
Swelling |
10 (17%) |
0 (0%) |
1 (2%) |
11 (19%) |
|
Fever |
2 (3%) |
0 (0%) |
0 (0%) |
2 (3%) |
|
Fatigue |
5 (8%) |
4 (7%) |
0 (0%) |
9 (15%) |
|
Nausea |
3 (5%) |
1 (2%) |
0 (0%) |
4 (7%) |
|
Headache |
15 (25%) |
6 (10%) |
1 (2%) |
22 (37%) |
|
Malaise |
5 (8%) |
5 (8%) |
0 (0%) |
10 (17%) |
|
Myalgias |
3 (5%) |
2 (3%) |
0 (0%) |
5 (8%) |
| Joint Pain | 4 (7%) | 3 (5%) | 0 (0%) | 7 (12%) |
*N represents the number of volunteers enrolled and who received the first vaccination. For the US Phase 1, five volunteers received the second and third vaccination with 10 μg MSP142/AS01. For the 50 μg MSP142/AS01 group, 20 received the first vaccination and 17 the second and third vaccination (#total of 54). In the Kenya Phase 1 study, 20 volunteers received the first and second vaccination with 50 μg MSP142/AS01 and 19 the third vaccination (#total of 59) while 10 volunteers received all three rabies vaccinations. Each volunteer is only counted one time per vaccination time point and the highest recorded grade for that AE is reported. G1 = Grade 1, G2 = Grade 2, G3 = Grade 3. Grading system describes degree of functional impairment (Grade 0: no impairment, Grade 1: easily tolerated, Grade 2: interferes with daily activity, Grade 3: prevents daily activity). Injection site redness and swelling grading were as follows: Grade 0: 0 mm, Grade 1: >1 - < 20 mm, Grade 2: >20 - < 50 mm, Grade 3: > 50 mm. Fever was graded by oral temperature: Grade 0: <37.5°C, Grade 1: >37.5 - < 38°C, Grade 2: >38 - < 39°C, Grade 3: >39°C.