POWERSAFETYTRUST

2 0 0 M I L L I O N V A C C I N A T I O N S O V E R 2 0 Y E A R S

IT’SALLABOUT

TRUST

POWERSAFETYTRUST

2 0 0 M I L L I O N V A C C I N A T I O N S O V E R 2 0 Y E A R S

IT’SALLABOUT

TRUSTIT’S

TRUS

BROAD ERYSIPELAS PROTECTION• Against all most common swine Erysipelas strains, 1a, 1b and 2

• Erysipelas may appear in:

– acute form: septicaemia, hyperthermia, anorexia, erythema and death

– sub acute /chronic forms: arthritis, endocarditis and orchitis

– indirect reproductive failure: return to heat, abortions, embryonic

death, infertility and decreased seminal quality

PARVOVIRUS PROTECTION • Against all strains of PPV causing reproductive problems to date

• Porcine parvovirus (PPV) is the major cause of reproductive failure in swine = SMEDI (stillbirth, mummi� cation, embryonic death and infertility)

• Piglets born viremic during infection

for broad and strong protection against Parvovirus and Erysipelas

VACCINATION IS THE ONLY WAY TO CONTROL THE DISEASES

38.3

38.6

38.9

39.2

39.5

D2D1D0+6hD0*

0

10

20

30

40

50

60

D2D1Day 0+6 h

(ºC)

(%)

a

a

bb

a

b b

a

b

b

a

aa

a

b

b a

a

bab

a

a, b : Values in same column holding di�erent superscripts are showing signi�cant di�erence (p<0.05)* Temperature on day 0 was used to covariate the rest of the temperature analysis

a, b : Values in same column holding di�erent superscripts are showing signi�cant di�erence (p<0.05)

Vaccine B

Vaccine A

PARVORUVAX

Vaccine B

Vaccine A

PARVORUVAX

A proper diagnosis of Parvo and Erysipelas is crucialDiagnosis of Parvovirus• Increased percentage of mummies, irregular returns

or decreased litter size, primarily in gilts, is suggestive of PPV infection

• PPV antigen in the lungs or liver of mummifi ed fetuses can be con� rmed using immuno� uorescence or PCR

• Paired serology of samples from gilts and sows can indicate the infection

Diagnosis of Erysipelas • High temperature and the diamond shaped skin

lesions are typical for the acute clinical disease

• Post-mortems, culture of the organism and /or PCR from the sudden deaths con� rms the diagnosis

• Paired serology using Hemagglutination Inhibition Test or ELISA can con� rm the exposure to the germ in sows or pigs

for broad and strong protection against Parvovirus and Erysipelas

Proven safety demonstrated in research and � eld experience over more than 20 years3 groups of sows were vaccinated with di� erent P+E vaccines (Morillo et al., IPVS 2010, 863)

38.3

38.6

38.9

39.2

39.5

D2D1D0+6hD0*

0

10

20

30

40

50

60

D2D1Day 0+6 h

(ºC)

(%)

a

a

bb

a

b b

a

b

b

a

aa

a

b

b a

a

bab

a

a, b : Values in same column holding di�erent superscripts are showing signi�cant di�erence (p<0.05)* Temperature on day 0 was used to covariate the rest of the temperature analysis

a, b : Values in same column holding di�erent superscripts are showing signi�cant di�erence (p<0.05)

Vaccine B

Vaccine A

PARVORUVAX

Vaccine B

Vaccine A

PARVORUVAX

VACCINATION IS THE ONLY WAY TO CONTROL THE DISEASES

: Safety

A VACCINE WITH AN EXCELLENT SAFETY PROFILE

38.3

38.6

38.9

39.2

39.5

D2D1D0+6hD0*

0

10

20

30

40

50

60

D2D1Day 0+6 h

(ºC)

(%)

a

a

bb

a

b b

a

b

b

a

aa

a

b

b a

a

bab

a

a, b : Values in same column holding di�erent superscripts are showing signi�cant di�erence (p<0.05)* Temperature on day 0 was used to covariate the rest of the temperature analysis

a, b : Values in same column holding di�erent superscripts are showing signi�cant di�erence (p<0.05)

Vaccine B

Vaccine A

PARVORUVAX

Vaccine B

Vaccine A

PARVORUVAX

Development of systemic reactions

Development of injection site reactions

induces both cell mediated and humoral immunity

Speci� c protective Cell Mediated Immunity

CMI is… CLEANING OUT INFECTION• mediated by IFNγ secreting cells (IFNγ-SC)

• measured in ELISPOT test

IL-4

IL-12

TH1 TH2

NK cells, TH2 cells,mast cells

RegulatoryTH2 cells

Eosinophilgrowth and

di�erentiaton

Mast-cellgrowth

B cell

IFN-γ

IFN-γ IFN-γ

IFN-γ

IFN-γ

IL-2

IL-12

IL-12IL-12

IL-4, IL-10

IL-5IL-3IL-4IL-10

IL-4 IL-5 IL-6IL-13

IL-4 IL-10IL-13

IL-18

IL-2TNF-β

TNF-βTNF-β

IFN-γ

Macrophageactivation

TCactivation

B cell

IgG2aIgM

IGG1 IGA IGE

NA + …

RegulatoryTH2 cells

IL-4

Macrophages

CMI

KILLS

Tc

PPV speci� c cytotoxic T-cellskill PPV infected cells

Erysipelas speci� c macrophage activation & SpaA facilitated kill

IFN-

IL-12

Zeeuw et al., J Gen Virol 88 (2007) 420-27; Joswik et al., J Gen Virol 90 (2009) 2437-41; A.L. Ingebritson, Th esis ISU 2009; Crussard et al., IPVS/ESPHM 2016, 259; Chae et al., Vet J 194 (2012) 151-157

Th e critical measures for DUAL PARVO AND ERY VACCINE PROTECTION are NA, Anti-SpaA & IFNγ-SC

Speci� c protective humoral immune response

Humoral immunity is… PROTECTING AGAINST EFFECT OF INFECTION

• mediated by small fractions of speci� c antibodies

• Erysipelas type 1a, 1b and 2Anti-SpaA – a specifi c opsonizing antibodymeasured by SpaA ELISA

• PPVneutralizing antibodies (NA) measured by serum neutralization test

induces both cell mediated and humoral immunity

IL-4

IL-12

TH1 TH2

NK cells, TH2 cells,mast cells

RegulatoryTH2 cells

Eosinophilgrowth and

di�erentiaton

Mast-cellgrowth

B cell

IFN-γ

IFN-γ IFN-γ

IFN-γ

IFN-γ

IL-2

IL-12

IL-12IL-12

IL-4, IL-10

IL-5IL-3IL-4IL-10

IL-4 IL-5 IL-6IL-13

IL-4 IL-10IL-13

IL-18

IL-2TNF-β

TNF-βTNF-β

IFN-γ

Macrophageactivation

TCactivation

B cell

IgG2aIgM

IGG1 IGA IGE

NA + …

RegulatoryTH2 cells

IL-4

Macrophages

Humoral

Erysipelas Speci� c Anti-SpaA inhibits bacterial action & facilitates phagocytosis

PPV speci� c NA blocks receptor contact & virus uptake

Humoral immunity is… PROTECTING AGAINST PROTECTING AGAINST EFFECT OF INFECTION EFFECT OF INFECTION

• mediated by small fractions of speci� c antibodies

• Erysipelas type 1a, 1b and 2Anti-SpaA – a specifi c opsonizing antibodymeasured by SpaA ELISAmeasured by SpaA ELISAmeasured by

• PPVneutralizing antibodies (NA) measured by serum neutralization test

TH2

RegulatoryTH2 cells

Eosinophilgrowth and

di�erentiaton

Mast-cellgrowth

B cell

IFN-γ

IL-12

IL-4, IL-10

IL-5IL-3IL-4IL-10

IL-4 IL-4 IL-5 IL-5 IL-6 IL-6IL-13

IL-4 IL-4IL-12 IL-4IL-12 IL-10IL-13

TNF-β

IgM

IGA IGE

NA + …

IgMIGG1IgM

IGA

Erysipelas Speci� c Anti-SpaA inhibits bacterial action & facilitates phagocytosis

PPV speci� c NA blocks receptor contact & virus uptake

Zeeuw et al., J Gen Virol 88 (2007) 420-27; Joswik et al., J Gen Virol 90 (2009) 2437-41; A.L. Ingebritson, Th esis ISU 2009; Crussard et al., IPVS/ESPHM 2016, 259; Chae et al., Vet J 194 (2012) 151-157 No correlation exists to general IgG ELISA s or HI tests

Th e critical measures for DUAL PARVO AND ERY VACCINE PROTECTION are NA, Anti-SpaA & IFNγ-SC

Th evenon et al., IPVS 2002, 561

8

6

4

2

047 49 51 53

Time (day)

Aver

age

daily

sym

ptom

scor

e

55 57 59

PARVORUVAX

1:10 Ery Ag vac.

1:100 Ery Ag vac.

Placebo

14

12

10

8

6

4

2

0

Mea

n fe

tuse

s num

ber

Unvaccinated

FETUSES VIABILITY IN UNVACCINATED AND VACCINATED GILTS

Vaccinated

Alive fetusesDead fetusesMummies

12.8born alive

2.1born alive

Joisel et al., IPVS 2004, 430

GIVES e�cient protection

Joisel et al.,

8

6

4

2

047 49 51 53

Time (day)

Aver

age

daily

sym

ptom

scor

e

55 57 59

PARVORUVAX

1:10 Ery Ag vac.

1:100 Ery Ag vac.

Placebo

PROVIDES POWERFUL AND BROAD DUAL PROTECTION AGAINST PARVOVIRUS AND ERYSIPELAS

Parvo e� cacy trialFoetus viability in unvaccinated and Parvoruvax vaccinated gilts

Erysipelas e� cacy trial Mean daily clinical score per group Challenge at day 50 with serotype 1 and 2 strains

: Conclusionon immune response

Th evenon et al., IPVS 2002, 561

GIVES e�cient protection

POWERSAFETYTRUSTPOWER

IFNγ-SC/CMI – a signi� cant and persistent cell mediated immune response against PPV and Erysipelas(Juillard et al., IPVS 2006, 162. Piras et al., IPVS 2006,160)

Neutralizing Antibodies – a powerful and long lasting protective humoral immune response against PPV (Brun et al., IPVS 2006,161)

Anti-SpaA Antibodies – a very quick and strong protective humoral immune response against Erysipelas• Even following � rst primo vaccination

• Specifi c Anti-SpaA antibodies as well as neutralizing antibodiesare linked directly to protection

• Poor correlation to general Ig tests like HI & ELISA

• Commercial ELISA’s are designed on various antigens to discover previous � eld infection.

(Crussard et al., IPVS/ESPHM 2016, 259)

Erysipelas e� cacy trial Mean daily clinical score per group Challenge at day 50 with serotype 1 and 2 strains

Primo vaccination Booster

SOWS AND GILTS

2 doses with a 3- to 4-week interval,

the second dose given at least 2 weeks before mating

At least 1 week before each mating

or 1 dose every six month

BOARS Vaccination twice with 3 weeks interval Every 6 months

Antib

odie

s

Age of giltsEntry in quarantine

INEFFICIENTVACCINATION

150 days5 months

180 days6 months

EFFICIENTVACCINATION

: vaccination scheme

Ceva Santé Animale S.A. - 10, av. de La Ballastière - 33500 Libourne - France - Phone: 00 33 (0) 5 57 55 40 40 - Fax: 00 33 (0) 5 57 55 42 37 - www.ceva.com - contact@ceva.com

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E F F IC AC Y & SA F E T YS OW & B OA R PRO T E C T IONL E A DI NG E X PE R I E NC E T H ROUG H 2 0 Y E A R S I N S O W S A N D G I L T S

POWERSAFETYTRUST

Parvoruvax® Suspension for Injection contains Inactivated Porcine Parvovirus (K-22 strain) and Erysipelothrix rhusiopathiae (lysed bacterial cells), serotype 2. Also contains aluminium hydroxide and thiomersal. The product is indicated for active immunisation of breeding pigs (sows, gilts and boars) against porcine parvovirosis, to reduce the number of stillbirths and mummi� ed piglets, and against erysipelas to reduce or prevent clinical symptoms. Vaccination can occasionally cause reactions of hypersensitivity in some animals, particularly in those animals sensitised by the erysipelas infection. In such case, appropriate treatment such as adrenaline should be provided. Rarely, vaccination can induce a small local reaction (<1.5 cm) at the site of injection without any e� ect on the health or productivity of the animal. The vaccination can cause a slight rise in body temperature (<0.2°C) that returns to normal values from 1 to 2 days after vaccination without any consequence to the health or productivity of the animal. Primary vaccination against porcine parvovirosis should not be carried out in the presence of maternally derived antibodies. Only healthy animals should be vaccinated. The vaccine is safe for use during pregnancy and lactation. However, avoid vaccination during the 3 weeks following service mating. Withdrawal periods: Zero days. Pharmaceutical precautions: Use immediately after opening. Store between 2°C and 8°C, protected from light. For more details, see the SPC applicable in your country.This page contains information on a veterinary biological product sold in several di� erent countries and areas where it may be subject to di� erent regulatory approvals. Ceva gives no guarantee that the details presented are correct with respect to all locations. In addition, the safety and e� cacy data and the withholding periods may be di� erent depending on local regulations. Please consult your veterinarian for further information.