2005 4-k o'connell c10 trial data final MSD Finca Productiva Salud Del Hato
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Transcript of 2005 4-k o'connell c10 trial data final MSD Finca Productiva Salud Del Hato
EU COVEXIN 10 LAUNCH
TRIAL DATA
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
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 + + + + +
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 ++ ++ ++ ++ ++ ++ ++
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
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)
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)
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)
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)
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)
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)
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)