Background
Methods
Study design and participants
Study vaccine
Procedures
Statistical analysis
Results
Study population
Immune response
N | Seroprotection rate (titre ≥ 1:40) % (95% CI) | Seroconversion rate* % (95% CI) | Geometric Mean Fold Rise** (95% CI) | N | Seroprotection rate (titre ≥ 1:40) % (95% CI) | Seroconversion rate* % (95% CI) | Geometric Mean Fold Rise** (95% CI) | |
---|---|---|---|---|---|---|---|---|
Vaccinated on Day 0 (subjects from Groups A and B pooled) 18–60 years | Vaccinated on Day 0 (subjects from Groups A and B pooled) 18>60 years | |||||||
Day 0 (Prevaccination)
| 160 |
14.4
| - | - | 136 |
5.1
| - | - |
(9.3-20.8) | (2.1-10.3) | |||||||
Day 21
| 160 |
97.5
|
96.3
|
45.0
| 136 |
91.9
|
89.0
|
23.4
|
(93.7-99.3) | (92.0-98.6) | (37.3-54.5) | (86.0-95.9) | (82.5-93.7) | (19.1-28.7) | |||
Group A Vaccinated on Day 0 and Day 21 18–60 years
|
Group A Vaccinated on Day 0 and Day 21 >60 years
| |||||||
Day 0 (Prevaccination)
| 87 |
12.6
| - | - | 83 |
7.2
| - | - |
(6.5-21.5) | - | (2.7-15.1) | ||||||
Day 21
| 87 |
100
|
100
|
51.6
| 83 |
90.4
|
89.2
|
23.0
|
(95.8-100) | (95.8-100) | (40.7-65.5) | (81.9-95.7) | (80.4-94.9) | (17.7-29.9) | |||
Day 42
| 87 |
100
|
98.9
|
86.7
| 83 |
100
|
98.8
|
54.9
|
(95.8-100) | (93.8-100) | (68.6-109.5) | (95.7-100) | (93.5-100) | (43.4-69.3) | |||
Day 182
| 85 |
97.6
|
92.9
|
26.6
| 83 |
90.4
|
86.7
|
13.4
|
(91.8-99.7) | (85.3-97.4) | (20.8-34.0) | (81.9-95.7) | (77.5-93.2) | (10.9-16.5) | |||
Day 203
| - | - | - | - | - | - | ||
Day 364
| 79 |
82.3
|
75.9
|
11.0
| 76 |
50.0
|
40.8
|
4.8
|
(72.1-90.0) | (65.0-84.9) | (9.2-15.5) | (38.3-61.7) | (29.6-52.7) | (3.8-6.1) | |||
Group B Vaccinated on Day 0 and Day 182 18–60 years
|
Group B Vaccinated on Day 0 and Day 182 >60 years
| |||||||
Day 0 (Prevaccination
| 67 |
14.9 (7.4-25.7) | - | - | 48 |
2.1 (0.1-11.1) | - | - |
Day 21
| 67 |
94.0
|
92.5
|
39.2
| 48 |
95.8
|
89.6
|
23.3
|
(85.4-98.3) | (83.4-97.5) | (28.3-54.2) | (85.7-99.5) | (77.3-96.5) | (16.6-32.7) | |||
Day 42
| 67 |
95.5
|
91.0
|
31.9
| 48 |
89.6
|
81.3
|
16.5
|
(87.5-99.1) | (81.5-96.6) | (23.4-43.4) | (77.3-96.5) | (67.4-91.1) | (11.8-23.0) | |||
Day 182
| 56 |
85.7
|
83.9
|
14.6
| 30 |
63.3
|
56.7
|
6.1
|
(73.8-93.6) | (71.7-92.4) | (10.8-19.7) | (43.9-80.1) | (37.4-74.5) | (3.9-9.4) | |||
Day 203
| 48 |
100
|
100
|
79.0
| 28 |
100
|
100
|
65.7
|
(92.6-100) | (92.6-100) | (58.0-107.7) | (87.7-100) | (87.7-100) | (41.4-104.1) | |||
Day 364
| 60 |
93.3
|
90.0
|
17.3
| 46 |
80.4
|
73.9
|
8.3
|
(83.8-98.2) | (79.5-96.2) | (13.0-23.0) | (66.1-90.6) | (58.9-85.7) | (6.0-11.3) |
Reactogenicity and safety
Symptom | Intensity | Group A Vaccinated on Day 0 and Day 21 | Group B Vaccinated on Day 0 and Day 182 | ||
---|---|---|---|---|---|
Dose 1% (95% CI) | |||||
18-60 years N = 92 | >60 years N = 90 | 18-60 years N = 70 | >60 years N = 52 | ||
Pain
| Any |
94.6
|
78.9
|
95.7
|
67.3
|
(87.8-98.2) | (69.0-86.8) | (88.0-99.1) | (52.9-79.7) | ||
Grade 3* |
0.0
|
2.2
|
0.0
|
0.0
| |
(0.0-3.9) | (0.3-7.8) | (0.0-5.1) | (0.0-6.8) | ||
Redness
| Any |
10.9
|
8.9
|
11.4
|
1.9
|
(5.3-19.1) | (3.9-16.8) | (5.1-21.3) | (0.0-10.3) | ||
>100 mm |
0.0
|
0.0
|
0.0
|
0.0
| |
(0.0-3.9) | (0.0-4.0) | (0.0-5.1) | (0.0-6.8) | ||
Swelling
| Any |
12.0
|
6.7
|
8.6
|
1.9
|
(6.1-20.4) | (2.5-13.9) | (3.2-17.7) | (0.0-10.3) | ||
>100 mm |
0.0
|
0.0
|
0.0
|
0.0
| |
(0.0-3.9) | (0.0-4.0) | (0.0-5.1) | (0.0-6.8) | ||
Dose 2% (95% CI)
| |||||
18-60 years N = 91
|
>60 years N = 85
|
18-60 years N = 60
|
>60 years N = 45
| ||
Pain
| Any |
87.9
|
72.9
|
90.0
|
57.8
|
(79.4-93.8) | (62.2-82.0) | (79.5-96.2) | (42.2-72.3) | ||
Grade 3* |
2.2
|
0.0
|
5.0
|
0.0
| |
(0.3-7.7) | (0.0-4.2) | (1.0-13.9) | (0.0-7.9) | ||
Redness
| Any |
6.6
|
12.9
|
10.0
|
6.7
|
(2.5-13.8) | (6.6-22.0) | (3.8-20.5) | (1.4-18.3) | ||
>100 mm |
0.0
|
0.0
|
3.3
|
2.2
| |
(0.0-4.0) | (0.0-4.2) | (0.4-11.5) | (0.1-11.8) | ||
Swelling
| Any |
8.8
|
11.8
|
16.7
|
8.9
|
(3.9-16.6) | (5.8-20.6) | (8.3-28.5) | (2.5-21.2) | ||
>100 mm |
0.0
|
0.0
|
0.0
|
0.0
| |
(0.0-4.0) | (0.0-4.2) | (0.0-6.0) | (0.0-7.9) |
Symptom | Intensity | Group A Vaccinated on Day 0 and Day 21 | Group B Vaccinated on Day 0 and Day 182 | ||
---|---|---|---|---|---|
Dose 1% (95% CI) | |||||
18-60 years N = 92 | >60 years N = 90 | 18-60 years N = 70 | >60 years N = 52 | ||
Fatigue
| Any |
43.5
|
28.9
|
38.6
|
34.6
|
(33.2-54.2) | (19.8-39.4) | (27.2-51.0) | (22.0-49.1) | ||
Grade 3* |
0.0
|
0.0
|
1.4
|
0.0
| |
(0.0-3.9) | (0.0-4.0) | (0.0-7.7) | (0.0-6.8) | ||
Headache
| Any |
37.0
|
22.2
|
31.4
|
17.3
|
(27.1-47.7) | (14.1-32.2) | (20.9-43.6) | (8.2-30.3) | ||
Grade 3* |
0.0
|
1.1
|
1.4
|
0.0
| |
(0.0-3.9) | (0.0-6.0) | (0.0-7.7) | (0.0-6.8) | ||
Joint pain at other location
| Any |
22.8
|
21.1
|
14.3
|
15.4
|
(14.7-32.8) | (13.2-31.0) | (7.1-24.7) | (6.9-28.1) | ||
Grade 3* |
0.0
|
0.0
|
0.0
|
0.0
| |
(0.0-3.9) | (0.0-4.0) | (0.0-5.1) | (0.0-6.8) | ||
Muscle aches
| Any |
46.7
|
28.9
|
32.9
|
28.8
|
(36.3-57.4) | (19.8-39.4) | (22.1-45.1) | (17.1-43.1) | ||
Grade 3* |
0.0
|
0.0
|
0.0
|
1.9
| |
(0.0-3.9) | (0.0-4.0) | (0.0-5.1) | (0.0-10.3) | ||
Shivering
| Any |
18.5
|
13.3
|
20.0
|
11.5
|
(11.1-27.9) | (7.1-22.1) | (11.4-31.3) | (4.4-23.4) | ||
Grade 3* |
0.0
|
1.1
|
0.0
|
0.0
| |
(0.0-3.9) | (0.0-6.0) | (0.0-5.1) | (0.0-6.8) | ||
Sweating
| Any |
13.0
|
11.1
|
10.0
|
13.5
|
(6.9-21.7) | (5.5-19.5) | (4.1-19.5) | (5.6-25.8) | ||
Grade 3* |
1.1
|
0.0
|
0.0
|
0.0
| |
(0.0-5.9) | (0.0-4.0) | (0.0-5.1) | (0.0-6.8) | ||
Fever (Axillary temp)
| Any |
1.1
|
1.1
|
2.9
|
1.9
|
(0.0-5.9) | (0.0-6.0) | (0.3-9.9) | (0.0-10.3) | ||
≥39.0 to ≤40°C |
0.0
|
0.0
|
0.0
|
0.0
| |
(0.0-3.9) | (0.0-4.0) | (0.0-5.1) | (0.0-6.8) | ||
Dose 2% (95% CI)
| |||||
18-60 years N = 91
|
>60 years N = 85
|
18-60 years N = 60
|
>60 years N = 45
| ||
Fatigue
| Any |
53.8
|
31.8
|
51.7
|
29.5
|
(43.1-64.4) | (22.1-42.8) | (38.4-64.8) | (16.8-45.2) | ||
Grade 3* |
3.3
|
1.2
|
3.3
|
0.0
| |
(0.7-9.3) | (0.0-6.4) | (0.4-11.5) | (0.0-8.0) | ||
Headache
| Any |
45.1
|
22.4
|
35.0
|
25.0
|
(34.6-55.8) | (14.0-32.7) | (23.1-48.4) | (13.2-40.3) | ||
Grade 3* |
1.1
|
1.2
|
5.0
|
0.0
| |
(0.0-6.0) | (0.0-6.4) | (1.0-13.9) | (0.0-8.0) | ||
Joint pain at other location
| Any |
19.8
|
24.7
|
26.7
|
27.3
|
(12.2-29.4) | (16.0-35.3) | (16.1-39.7) | (15.0-42.8) | ||
Grade 3* |
0.0
|
0.0
|
0.0
|
0.0
| |
(0.0-4.0) | (0.0-4.2) | (0.0-6.0) | (0.0-8.0) | ||
Muscle aches
| Any |
42.9
|
29.4
|
51.7
|
34.1
|
(32.5-53.7) | (20.0-40.3) | (38.4-64.8) | (20.5-49.9) | ||
Grade 3* |
0.0
|
0.0
|
1.7
|
0.0
| |
(0.0-4.0) | (0.0-4.2) | (0.0-8.9) | (0.0-8.0) | ||
Shivering
| Any |
28.6
|
15.3
|
18.3
|
15.9
|
(19.6-39.0) | (8.4-24.7) | (9.5-30.4) | (6.6-30.1) | ||
Grade 3* |
1.1
|
1.2
|
0.0
|
0.0
| |
(0.0-6.0) | (0.0-6.4) | (0.0-6.0) | (0.0-8.0) | ||
Sweating
| Any |
20.9
|
16.5
|
13.3
|
9.1
|
(13.1-30.7) | (9.3-26.1) | (5.9-24.6) | (2.5-21.7) | ||
Grade 3* |
1.1
|
0.0
|
0.0
|
0.0
| |
(0.0-6.0) | (0.0-4.2) | (0.0-6.0) | (0.0-8.0) | ||
Fever (Axillary temp)
| Any |
6.6
|
5.9
|
1.7
|
0.0
|
(2.5-13.8) | (1.9-13.2) | (0.0-8.9) | (0.0-8.0) | ||
≥39.0 to ≤40°C |
0.0
|
2.4
|
0.0
|
0.0
| |
(0.0-4.0) | (0.3-8.2) | (0.0-6.0) | (0.0-8.0) |