Engerix® -B
| | | |
HBsAg + IMP321 10 μg
| | | |
---|
Subject
|
W0
|
W8
|
W12
|
Subject
|
W0
|
W8
|
W12
|
003
|
0
|
178
|
2253
|
013
|
0
|
0
|
1
|
008
|
0
|
2589
|
7055
|
015
|
0
|
0
|
4
|
014
|
0
|
0
|
54
|
017
|
0
|
0
|
0
|
023
|
0
|
4
|
442
|
018
|
0
|
2
|
28
|
026
|
0
|
3054
|
3156
|
019
|
9
|
504
|
609
|
032
|
0
|
0
|
28
|
020
|
0
|
0
|
0
|
040
|
0
|
9
|
164
|
1021
|
0
|
0
|
0
|
043
|
0
|
2
|
17
|
022
|
0
|
0
|
0
|
# Seroconverteda
|
0
|
6 (75%)
|
8 (100%)
|
# Seroconverteda
|
0
|
1 (14.2%)
|
3 (42.8%)
|
# Seroprotecteda
|
0
|
3 (37.5%)
|
8 (100%)
|
# Seroprotecteda
|
0
|
0
|
1 (14.2%)
|
GMTa, b
|
1
|
23.75
|
313.56
|
GMTa, b
|
1
|
1.10
|
1.96
|
HBsAg alone
| | | |
HBsAg + IMP321 30 μg
| | | |
006
|
0
|
0
|
0
|
025
|
0
|
0
|
0
|
012
|
0
|
0
|
0
|
027
|
0
|
0
|
0
|
016
|
0
|
0
|
0
|
029
|
0
|
0
|
0
|
024
|
0
|
0
|
0
|
030
|
0
|
0
|
26
|
028
|
0
|
0
|
7
|
031
|
0
|
0
|
0
|
034
|
0
|
0
|
0
|
033
|
0
|
0
|
4
|
039
|
0
|
0
|
2
|
035
|
2
|
136
|
467
|
044
|
1
|
24
|
321
|
036
|
0
|
0
|
0
|
# Seroconverteda
|
0
|
0
|
2 (28.5%)
|
# Seroconverteda
|
0
|
0
|
2 (28.5%)
|
# Seroprotecteda
|
0
|
0
|
0
|
# Seroprotecteda
|
0
|
0
|
1 (14.2%)
|
GMTa, b
|
1
|
1
|
1.46
|
GMTa, b
|
1
|
1
|
1.94
|
HBsAg + IMP321 3 μg
| | | |
HBsAg + IMP321 100 μg
| | | |
001
|
0
|
540
|
2229
|
037
|
0
|
0
|
3
|
002
|
0
|
35
|
51
|
038
|
0
|
0
|
3
|
004
|
0
|
0
|
0
|
041
|
0
|
0
|
0
|
005
|
0
|
0
|
0
|
042
|
0
|
0
|
0
|
007
|
0
|
0
|
1
|
045
|
0
|
0
|
0
|
009
|
0
|
0
|
12
|
046
|
0
|
0
|
0
|
1010
|
0
|
0
|
1
|
047
|
0
|
0
|
0
|
011
|
0
|
0
|
5
|
048
|
0
|
0
|
0
|
# Seroconverteda
|
0
|
2 (25%)
|
6 (75%)
|
# Seroconverteda
|
0
|
0
|
2 (25%)
|
# Seroprotecteda
|
0
|
2 (25%)
|
3 (37.5%)
|
# Seroprotecteda
|
0
|
0
|
0
|
GMTa, b
|
1
|
3.42
|
7.15
|
GMTa, b
|
1
|
1
|
1.31
|
- Protective titres are indicated in bold
- a GMT, seroconversion and seroprotection calculations were based on naïve subjects only.
- b Value of zero are assigned the value of 1 for the GMT calculation.