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EU COVEXIN 10 LAUNCH
TRIAL DATA
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Protective Antitoxin Levels
Clostridia Protective levelof antibody
Pharmcopoeia or 9CFR listedpotency level
C. tetani 0.1 U/mL 2.5 U/mL or 2.0 U/mLC. novyi type B 0.1 – 0.4 U/mL 3.5 U/mL or 0.5 U/mLC. perfringens type A 0.1 U/mL NoneC. perfringens types B and C( beta toxin)
0.5 U/mL 10 U/mL
C. perfringens type D(epsilon toxin)
0.1 U/mL 5.0 U/mL or 2.0 U/mL
C. sordellii 0.1 – 0.2 U/mL 1.0 U/mLC. haemolyticum 20 – 40 U/mL NoneC. septicum 0.5 U/mL 2.5 U/mL
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Table of Susceptibility for CattleClostridium Approximate Age of Susceptibility*
0 – 14 days 2 – 13 weeks 3 – 12 months 1 – 3 years >3 yearsC. perfringens type A + + + - -C. perfringens type B + + + - -C. perfringens type C + + + - -C. perfringens type D + + + + -C. septicum + + + + -C. chauvoei - - + + -C. novyi B - - + + +C. sordellii - - + + -C. haemolyticum - - - + +C. tetani + + + + +
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Table of Susceptibility for Sheep
Clostridium Approximate Age of Susceptibility 0–14
days 2–4 weeks
4-12 weeks
3–6 months
6-12 months
1-3years >3 years
C. perfringens type A ++ + + C. perfringens type B ++ + + C. perfringens type C ++ + + + + C. perfringens type D ++ + ++ + + C. septicum ++ + + ++ ++ C. chauvoei + + ++ ++ ++ ++ ++ C. novyi B + ++ ++ C. sordellii ++ ++ + ++ + ++ C. haemolyticum ++ ++ C. tetani ++ ++ ++ ++ ++ ++ ++
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VaccinateGroup
ControlGroup
MonitorGroup
Vaccinate2 weeks age Monitor
Vaccinate2 weeks age
Bleed 10 weeks Bleed 10 weeks Bleed 10 weeks
Boost 8 monthsBleed 1 week later
Boost 8 monthsBleed 1 week later
Boost 8 monthsBleed 1 week later
Last vaccination2 weeks prior toParturition
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Results for C. tetani
0
5
10
15
20
25
30
Vaccinate Control Monitor
Ant
ibod
y Le
vel (
u/m
l)
Dams (V2 + 14)Calves (V1, 2 weeks of age)Calves (V2 + 14, 10 weeks of age)Calves (26 weeks post V2)Calves (27 weeks post V2)
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Results for C. tetani
0
2
4
6
8
10
12
14
Vaccinate Control Monitor
Antib
ody
Leve
l (u/
ml)
Dams Day 56 (V2 + 14)
Lambs Day 76 (V1, 2 weeks of age)
Lambs Day 132 (V2 + 14, 10 weeks of age)
Lambs Day 300 (26 weeks post V2)
Lambs Day 307 ( 27 weeks post V2)
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Results for C. novyi type B
0
1
2
3
4
5
6
7
8
Vaccinate Control Monitor
Ant
ibod
y Le
vel (
u/m
l)
Dams (V2 + 14)Calves (V1, 2 weeks of age)Calves (V2 + 14, 10 weeks of age)Calves (26 weeks post V2)Calves (27 weeks post V2)
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Results for C. novyi type B
0
5
10
15
20
25
Vaccinate Control Monitor
Antib
ody
Leve
l (u/
ml)
Dams Day 56 (V2 + 14)Lambs Day 76 (V1, 2 weeks of age)Lambs Day 132 (V2 + 14, 10 weeks of age)Lambs Day 300 (26 weeks post V2)Lambs Day 307 ( 27 weeks post V2)
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Results for C. perfringens type A
0
0.5
1
1.5
2
2.5
3
3.5
4
Vaccinate Control Monitor
Ant
ibod
yLev
el (u
/ml)
Dams (V2 + 14)Calves (V1, 2 weeks of age)Calves (V2 + 14, 10 weeks of age)Calves (26 weeks post V2)Calves (27 weeks post V2)
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Results for C. perfringens type A
0
0.2
0.4
0.6
0.8
1
1.2
1.4
1.6
Vaccinate Control Monitor
Antib
odyL
evel
(u/m
l)
Dams Day 56 (V2 + 14)Lambs Day 76 (V1, 2 weeks of age)Lambs Day 132 (V2 + 14, 10 weeks of age)Lambs Day 300 (26 weeks post V2)Lambs Day 307 ( 27 weeks post V2)
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Results for C. perfringens type B/C
0
10
20
30
40
50
60
70
Vaccinate Control Monitor
Ant
ibod
y Le
vel (
u/m
l)
Dams (V2 + 14)Calves (V1, 2 weeks of age)Calves (V2 + 14, 10 weeks of age)Calves (26 weeks post V2)Calves (27 weeks post V2)
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Results for C. perfringens type B/C
0
10
20
30
40
50
60
Vaccinate Control Monitor
Antib
ody
Leve
l (u/
ml)
Dams Day 56 (V2 + 14)Lambs Day 76 (V1, 2 weeks of age)Lambs Day 132 (V2 + 14, 10 weeks of age)Lambs Day 300 (26 weeks post V2)Lambs Day 307 ( 27 weeks post V2)
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Results for C. perfringens type D
0
0.5
1
1.5
2
2.5
3
3.5
4
4.5
5
Vaccinate Control Monitor
Ant
ibod
y Le
vel (
u/m
l)
Dams (V2 + 14)Calves (V1, 2 weeks of age)Calves (V2 + 14, 10 weeks of age)Calves (26 weeks post V2)Calves (27 weeks post V2)
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Results for C. perfringens type D
0
5
10
15
20
25
30
35
40
Vaccinate Control Monitor
Antib
ody
Leve
l (u/
ml)
Dams Day 56 (V2 + 14)Lambs Day 76 (V1, 2 weeks of age)Lambs Day 134 (V2 + 14, 10 weeks of age)Lambs Day 300 (26 weeks post V2)Lambs Day 307 ( 27 weeks post V2)
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Results for C. septicum
0
2
4
6
8
10
12
14
16
Vaccinate Control Monitor
Ant
ibod
y Le
vel (
u/m
l)
Dams (V2 + 14)Calves (V1, 2 weeks of age)Calves (V2 + 14, 10 weeks of age)Calves (26 weeks post V2)Calves (27 weeks post V2)
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US Trial Data for US Trial Data for C. septicumC. septicum
Mean C. septicum ELISA Titers in Calves After Vaccination
00.05
0.10.150.2
0.25
0.30.35
Covexin 8 Vision 8 Controls
Tite
rs in
Cal
ves
at V
2 +1
4
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Results for C. septicum
0
1
2
3
4
5
6
7
8
9
Vaccinate Control Monitor
Antib
ody
Leve
l (u/
ml)
Dams Day 56 (V2 + 14)Lambs Day 76 (V1, 2 weeks of age)Lambs Day 132 (V2 + 14, 10 weeks of age)Lambs Day 300 (26 weeks post V2)Lambs Day 307 ( 27 weeks post V2)
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Results for C. sordellii
0
1
2
3
4
5
6
Vaccinate Control Monitor
Ant
ibod
y Le
vel (
u/m
l)
Dams (V2 + 14)Calves (V1, 2 weeks of age)Calves (V2 + 14, 10 weeks of age)Calves (26 weeks post V2)Calves (27 weeks post V2)
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Results for C. sordellii
0
2
4
6
8
10
12
14
16
Vaccinate Control Monitor
Antib
ody
Leve
l (u/
ml)
Dams Day 56 (V2 + 14)Lambs Day 76 (V1, 2 weeks of age)Lambs Day 132 (V2 + 14, 10 weeks of age)Lambs Day 300 (26 weeks post V2)Lambs Day 307 ( 27 weeks post V2)
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Results for C. chauvoei
0
0.05
0.1
0.15
0.2
0.25
0.3
0.35
0.4
0.45
0.5
Vaccinate Control Monitor
Ant
ibod
y Le
vel (
u/m
l)
Dams (V2 + 14)Calves (V1, 2 weeks of age)Calves (V2 + 14, 10 weeks of age)Calves (26 weeks post V2)Calves (27 weeks post V2)
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Results for C. chauvoei
0
0.5
1
1.5
2
2.5
3
3.5
4
Vaccinate Control Monitor
Antib
ody
Leve
l (u/
ml)
Dams Day 56 (V2 + 14)Lambs Day 76 (V1, 2 weeks of age)Lambs Day 132 (V2 + 14, 10 weeks of age)Lambs Day 300 (26 weeks post V2)Lambs Day 307 ( 27 weeks post V2)
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Results for C. haemolyticum
0
20
40
60
80
100
120
140
Vaccinate Control Monitor
Ant
ibod
y Le
vel (
u/m
l)
Dams (V2 + 14)Calves (V1, 2 weeks of age)Calves (V2 + 14, 10 weeks of age)Calves (26 weeks post V2)Calves (27 weeks post V2)
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Results for C. haemolyticum
0
10
20
30
40
50
60
70
Vaccinate Control Monitor
Antib
ody
Leve
l (u/
ml)
Dams Day 56 (V2 + 14)Lambs Day 76 (V1, 2 weeks of age)Lambs Day 132 (V2 + 14, 10 weeks of age)Lambs Day 300 (26 weeks post V2)Lambs Day 307 ( 27 weeks post V2)
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