2005 4-k o'connell c10 trial data final msd finca productiva salud del hato

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EU COVEXIN 10 LAUNCH TRIAL DATA

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Page 1: 2005 4-k o'connell c10 trial data final MSD Finca Productiva Salud Del Hato

EU COVEXIN 10 LAUNCH

TRIAL DATA

Page 2: 2005 4-k o'connell c10 trial data final MSD Finca Productiva Salud Del Hato

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

Page 3: 2005 4-k o'connell c10 trial data final MSD Finca Productiva Salud Del Hato

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 + + + + +

Page 4: 2005 4-k o'connell c10 trial data final MSD Finca Productiva Salud Del Hato

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 ++ ++ ++ ++ ++ ++ ++

Page 5: 2005 4-k o'connell c10 trial data final MSD Finca Productiva Salud Del Hato

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

Page 6: 2005 4-k o'connell c10 trial data final MSD Finca Productiva Salud Del Hato

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)

Page 7: 2005 4-k o'connell c10 trial data final MSD Finca Productiva Salud Del Hato

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)

Page 8: 2005 4-k o'connell c10 trial data final MSD Finca Productiva Salud Del Hato

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)

Page 9: 2005 4-k o'connell c10 trial data final MSD Finca Productiva Salud Del Hato

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)

Page 10: 2005 4-k o'connell c10 trial data final MSD Finca Productiva Salud Del Hato

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)

Page 11: 2005 4-k o'connell c10 trial data final MSD Finca Productiva Salud Del Hato

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)

Page 12: 2005 4-k o'connell c10 trial data final MSD Finca Productiva Salud Del Hato

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)

Page 13: 2005 4-k o'connell c10 trial data final MSD Finca Productiva Salud Del Hato

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)

Page 14: 2005 4-k o'connell c10 trial data final MSD Finca Productiva Salud Del Hato

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)

Page 15: 2005 4-k o'connell c10 trial data final MSD Finca Productiva Salud Del Hato

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)

Page 16: 2005 4-k o'connell c10 trial data final MSD Finca Productiva Salud Del Hato

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)

Page 17: 2005 4-k o'connell c10 trial data final MSD Finca Productiva Salud Del Hato

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

Page 18: 2005 4-k o'connell c10 trial data final MSD Finca Productiva Salud Del Hato

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)

Page 19: 2005 4-k o'connell c10 trial data final MSD Finca Productiva Salud Del Hato

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)

Page 20: 2005 4-k o'connell c10 trial data final MSD Finca Productiva Salud Del Hato

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)

Page 21: 2005 4-k o'connell c10 trial data final MSD Finca Productiva Salud Del Hato

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)

Page 22: 2005 4-k o'connell c10 trial data final MSD Finca Productiva Salud Del Hato

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)

Page 23: 2005 4-k o'connell c10 trial data final MSD Finca Productiva Salud Del Hato

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)

Page 24: 2005 4-k o'connell c10 trial data final MSD Finca Productiva Salud Del Hato

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)

Page 25: 2005 4-k o'connell c10 trial data final MSD Finca Productiva Salud Del Hato