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More than just an update
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Reducing influenza risk
means always looking ahead.
New Equilis® Prequenza helps
you succeed like no other.
If protecting horses against equine influenza were just a matter of vaccinating, life would be easier.
Protecting horses against equine influenza means that a significant proportion of the population needs
to be vaccinated appropriately and regularly. It means always looking ahead to ensure the most effective
protection possible at all times.
Vaccines against equine influenza reduce the severity of clinical signs and virus excretion after infection.
Outbreaks of equine influenza continue to occur, due to the multiple factors impacting disease prevention
and the complexity of maintaining herd immunity.
Far more than just an update, new Equilis Prequenza employs a broad-based approach to provide the best
protection against equine influenza through enhanced immunogenicity. This can only be achieved through
a combination of adjuvant, antigen and strain. Equilis Prequenza addresses all of these key factors.
Host
Management
Horses, donkeys and mules of all breeds and ages.
Appropriate and regular vaccination – primary
course and revaccination.
Viral respiratory disease severity depends on vaccination
status, stress, age, exercise, secondary infection.
Vaccination reduces severity of clinical signs
and virus excretion after infection.
Economically important – prolonged periods
of rest to reach full recovery.
Minimize stress and mixing – shipping,
training, diet change(s), new environment(s).
Ventilation.
Virus
Factors of
Disease
Prevention
Host specific lineage – H3N8.
Frequently present: frequent infection and disease.
Almost worldwide distribution.
Rapid transmission – short incubation.
Antigenic drift – slowly moving target.
Biosecurity – good hygiene (fomites) and
isolation of cases and in contact horses.
Herd immunity
Significant proportion of the population needs
to be vaccinated appropriately and regularly.
Protect the most susceptible – < 3 years old.
Quarantine new horses (for 2 weeks) before mixing.
Protect new horses.
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Enhanced Protection
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Influenza continues to evolve. So does
Equilis Prequenza. The broad-based approach
led us to make changes in a number of key
areas to enhance immunogenicity.
Patented Matrix-C adjuvant
™
Equine influenza vaccines all rely on adjuvants to help
stimulate the host’s immune response to the target
antigen(s). Equilis Prequenza is different – thanks to
Matrix-C™ technology.
Matrix-C is unique because it allows for rapid uptake
by cells of the immune system. Within a few hours
after vaccination the adjuvant has moved from the
vaccination site to the draining lymph nodes and
eventually to the spleen and bone marrow where most
of the immune cells reside.1,2
Matrix-C provides broad protection by stimulating
both antibody production and a cell-mediated
immune response in the horse.3 This broad-based
protection mimics natural infection.
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The Matrix-C™ structure is unique. Matrix-C forms
unique spherical open cage-like structures (typically
40nm in diameter). This complex displays immune
stimulating properties and is thus used to induce
Adjuvant Technology Platform
ISCOM
Matrix-C
a stronger immune response.
Matrix-C contains more purified saponin and has
no restrictions on the amount and type of antigens
that can be included. This leads to increased
immunogenicity due to optimization of the mixture
of antigens with adjuvant.
Saponin mixture.
Purified saponin – fraction C.
Antigen and adjuvant
form complex.
Antigens mixed with, but
separate from, adjuvant.
More variable particle size.
More consistent particle
size.
Limited by amount and
type of antigen.
Unique and patented.
Rapid uptake from injection site.
Stimulates antibody production and cell-mediated immune response.
Stronger immune response.
Updated strain
Equilis Prequenza now contains Newmarket/2/93 with South Africa/4/03, a Florida clade 1 strain the only vaccine to date to adopt this prototype strain.4 Equilis Prequenza also has demonstrated
cross-protection against Richmond/1/07,5 the most recent prototype of a clade 2 strain, as well as
Ohio/03.
Innovative cell line production
Equilis Prequenza is produced in a well-established and reliable mammalian cell
culture system.
This system reduces the need for the purification steps required when
influenza viruses are cultured in the traditional way in hen’s eggs.
M
aintains the immunogenicity of influenza virus, through preventing
the loss of haemagglutinin N-glycosylation.6
Whole virus
Equilis Prequenza now includes whole equine influenza virus. Whole virus is important because
it presents all of the antigenic components of the virus – both external and internal –
to the immune system. Vaccine strategies against influenza have traditionally focused on
generating antibody responses to the external glycoprotein antigens haemagglutinin and
neuraminidase. While antibodies to these external antigens are important, they are not the
whole story. Equilis Prequenza helps ensure adequate and robust protection by presenting
both external and internal antigens to the host’s immune system.
P
resents both internal and external antigens to the
immune system, ensuring robust protection.
Respiratory
tract
Matrix
M2 protein
RNA
Internal antigens:
External antigens:
Matrix
M2 protein
RNA
Nucleoprotein and
polymerases
Neuraminidase
Haemagglutinin
WHOLE
INFLUENZA
VIRUS
Nucleoprotein and
polymerases
Neuraminidase
Haemagglutinin
Viral messenger RNA
Viral RNA
Virus
Ribosome
from cell
Endosome
Sialic acid
Viral proteins
INFECTED
CELL
Cell nucleus
Viral RNA copies
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Proven Efficacy
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Efficacy has been demonstrated in stringent challenge trials where vaccinated horses were
protected against American lineage Florida clade 1 and 2 sublineage strains.7-11
Always looking ahead for emerging virulent strains, we are among the first to show protection
against Richmond/1/07, the most recent prototype of a clade 2 strain, as well as the heterologous
clade 1 strain Ohio/03.4 There is both challenge and longer term serology data to support the
efficacy of this vaccine.5,12,13
Efficacy confirmed by challenge
A group of seven horses was vaccinated twice intramuscularly with Equilis Prequenza Te.
They were challenged individually, together with a group of five non-vaccinated controls, with
an aerosol delivering 108.5 EID50 of equine influenza virus strain Richmond/1/07 three weeks
after second vaccination.12 All of the horses were monitored for clinical signs and samples
were taken to determine virus shedding until 14 days after the challenge.
Temperature: Vaccinated horses had significantly lower mean and peak rectal temperatures
than the control horses. Vaccinated horses had a 0.79°C lower rectal temperature (p=0.004)
and 1.70°C lower peak rectal temperature (p=0.002) than controls. The change in rectal
temperature from baseline of 8.38°C days was also significantly lower in the vaccinated
horses than in the controls (p=0.005).
Rectal temperature ºC
41.0
Temperature
40.5
40.0
Prequenza
39.5
Controls
39.0
38.5
38.0
37.5
37.0
-1
0
1
2
3
4
5
6
7
8
Days after challenge
9
10
11
12
13
14
Clinical signs: Vaccination had a statistically significant effect on the total clinical score
(p=0.012). Vaccinated horses were 12 times more likely to have a lower total clinical score than
the controls. Vaccination also had a statistically significant effect on the clinical score (p=0.022).
Vaccinated horses also had 7.9 times lower clinical scores than controls, indicating that the
clinical signs were fewer and milder in the vaccinated horses.
8
Clinical signs
Total clinical score
7
6
Prequenza
5
Controls
4
3
2
1
0
-1
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
Days after challenge
Virus shedding: Vaccination had a highly significant effect on the extent of viraemia (titre,
p=0.001), duration of virus excretion (p=0.0005) and total amount of virus excreted (AUC,
p=0.001). Vaccinated horses had significantly lower viraemia for significantly fewer days
(average 1.1 days) than control horses (6.4 days). Vaccinated horses were 99.6% less likely to
excrete virus than control horses.
Virus excretion (EID 50/ml)
5
Virus shedding
4
Prequenza
3
Controls
2
1
0
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
Days after challenge
A similar study was performed in 7 vaccinated and 5 control horses using 107.9 EID50 Ohio/03
as challenge virus. This study had similar results.13 Vaccination had a highly significant effect on
rectal temperature (p=0.0135), total clinical score (p=0.027) and viraemia (p=0.0003).
Vaccinated horses were 84% less likely to excrete virus than control horses.
Longer term protection confirmed by serology
In a further study, vaccinated horses were followed serologically. There were still pronounced antibody titres at
18 weeks after second vaccination and this was equivalent to what has been demonstrated previously.5
12
Serology
Antibody titer (log2)
10
South Africa/4/03
8
Newmarket/2/93
6
4
2
0
0
V1
2
4
V2
6
8
10
12
14
16
18
20
22
Week
Significantly reduces both clinical signs and virus shedding.
P
rovides a reliable tool in the protection of horses against
a recent virulent strain of equine influenza.
Induces a long-lasting immune response.
Link to previous challenge studies
Efficacy has been demonstrated in stringent challenge trials where vaccinated horses were
protected against American lineage strains, such as South Africa/4/03 and Ohio/03 (both
from the Florida clade 1 sublineage) and Newmarket/5/03 (Florida clade 2), three weeks after
a basic vaccination course (two vaccinations) and, Kentucky/9/95, four weeks and five months
after a basic vaccination course and one year after third vaccination.7-11 The data from these
studies is relevant now too, since the serological response to this vaccine is similar to that
of its predecessor.
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Convenience
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Easy-to-identify syringe plungers.
E
asy-to-identify color coded vial caps.
Choice of syringes or vials.
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Vaccine Expertise
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The equine vaccine leader in Europe
MSD Animal Health is the equine vaccine market leader in Europe.
Proven track record
O
ver 7 million doses of Equilis Prequenza (Te) sold and an excellent track record of very rare
systemic and local (<7 per 100,000 doses sold) reactions.5
Equilis Prequenza studies using pregnant thoroughbred mares have shown few local reactions,
no systemic reactions and no impact on equine pregnancy.5 By choosing Equilis Prequenza, you’re
choosing a vaccine with a proven track record.
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Vaccination Schedule
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Onset
of immunity:
– 2 weeks after the primary
vaccination course.
Duration
of immunity:
– 5 months after the primary
vaccination course
–1
2 months after the first revaccination.
Primary vaccination course
Administer one dose (1 mL) of Equilis Prequenza Te, by intramuscular injection, according
to the following schedule:
First vaccination (V1) from 6 months of age, second vaccination (V2) 4 weeks later.
In case of increased risk of infection or insufficient colostrum intake, an additional initial injection
can be administered at 4 months of age followed by the full vaccination program (primary
vaccination course at 6 months of age and 4 weeks later).
Revaccination
The first revaccination (V3) should be administered 5 months after the primary vaccination
course. The immune response to this vaccination will provide immunity to equine influenza
for at least 12 months. The second revaccination (V4) should be administered within 12 months
of the first revaccination. The alternate use, at 12-month intervals, of Equilis Prequenza with
Equilis Prequenza Te is recommended to maintain immunity levels for the tetanus component
(see schematic diagram).
Primary vaccination
course
Revaccination
4 weeks
V1
5 months
V2
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Revaccination
12 months
V3
V4
N.B. This schedule is based on the results of studies conducted by MSD Animal Health. Please be aware that some national and international
associations (such as the Fédération Equestre Internationale (FEI)) require vaccination every 6 months to participate in competitions.
Today, there are more reasons than
ever to choose Equilis Prequenza
Enhanced Protection
Matrix-CTM adjuvant
U
pdated strain – Newmarket/2/93
with South Africa/4/03
Innovative cell line production
Proven Efficacy
S
tringent challenge studies with
Richmond/1/07 and Ohio/03
Serological evidence of long-term protection
Serological link to previous challenge studies
Whole virus
Convenience
Vaccine Expertise
Easy-to-identify syringe plungers
The equine vaccine leader in Europe
Easy-to-identify color coded vial caps
P
roven track record – local and systemic
reactions are very rare
Choice of syringes or vials
References
1.
Pearse MJ, Drane D. Adv Drug Dev Rev. 2005;57:465-474.
2.
Pearse MJ, Drane D. Vaccine. 2004;22:2391-2395.
3.
Paillot R, Prowse L. Vet Immunol Immunopathol. 2012;145:516–521.
4.
OIE Expert Surveillance Panel. Bulletin de l’OIE 2012;2;46-47.
5.
European Medicines Agency. Equilis Prequenza and Equilis Prequenza Te
European Public Assessment Reports - Product Information. www.emea.europa.eu
6.
Hütter J, Rödig JV, Höper D et al. J Immunol. 2013;190:220-230.
7.
Heldens JGM, Pouwels HGW, Derks CGG et al. Vaccine. 2009;27:5530–5537.
8.
Heldens JGM, Pouwels HGW, Derks CGG et al. Vaccine. 2010;28:6989-6996.
9.
Ragni-Alunni R, van de Zande SMA. In Proc. SVH Årsmøde, Ebeltoft, Denmark 3 - 5
November 2006.
10.
Ragni-Alunni R,van de Zande SMA. Ippologia. 2008;19:9-14.
11.
van de Zande SMA, Ragni-Alunni R. In Proc. 10th International Congress WEVA,
Moscow, Russia, 28 Jan – 1 Feb 2008.
12.
Data on file. MSD Animal Health. Report 2012;12R/0193
13.
Data on file. MSD Animal Health. Report 2011;10R/0179
Intervet International BV - P.O. Box 31, 5830 AA Boxmeer - The Netherlands
Phone: +31 (0)485 587600 - Fax: +31 (0)485 577333 www.msd-animal-health.com
© 2013 Intervet International B.V., a subsidiary of Merck & Co., Inc.,
Whitehouse Station, NJ, USA. All rights reserved.
2013_GAH_EQ_004
“Placeholder for Data Sheet”
Felleskatalogtekster:
Equilis Prequenza Intervet/MSD Animal Health
Vaksine mot influensa hos hest.
ATCvet-nr.: QI05A A01
INJEKSJONSVÆSKE, suspensjon til hest: 1 dose (1 ml) inneh.: Hesteinfluensavirus: A/equine-2/South Africa/4/03 50 AU, A/equine-2/Newmarket/2/93 50 AU,
renset saponin, kolesterol, fosfatidylkolin, fosfatbuffer.
Egenskaper: Virkningsmekanisme: Stimulerer til aktiv immunisering mot hesteinfluensa.
Indikasjoner: Aktiv immunisering av hester fra 6 måneders alder mot hesteinfluensa, ved å redusere kliniske symptomer og virusspredning etter infeksjon.
Begynnende immunitet: 2 uker etter grunnimmunisering. Varighet av immunitet: 5 måneder etter grunnimmunisering, 12 måneder etter 1. revaksinering.
Bivirkninger: En diffus hard eller bløt hevelse (maks. 5 cm i diameter), som går tilbake innen 2 dager, kan forekomme. I svært sjeldne tilfeller kan det forekomme en lokal hevelse >5 cm som kan vare >2 dager. Smerte på injeksjonsstedet kan forekomme i sjeldne tilfeller og resultere i kortvarig funksjonelt
ubehag (stivhet). I svært sjeldne tilfeller kan feber, noen ganger fulgt av letargi og mangel på appetitt, forekomme i 1 dag, unntaksvis i opp til 3 dager.
Forsiktighetsregler: Pga. mulig interferens med maternelle antistoffer, skal føll ikke vaksineres før ved 6 måneders alder, spesielt føll født av hopper som
ble revaksinert i løpet av de 2 siste månedene av drektigheten.
Interaksjoner: Ingen informasjon er tilgjengelig vedrørende sikkerhet og effekt ved bruk sammen med andre preparater. Det må derfor avgjøres i det enkelte tilfelle om denne vaksinen skal brukes før eller etter et annet veterinærpreparat.
Drektighet/Laktasjon: Kan brukes under drektighet og laktasjon.
Dosering: Kun friske dyr skal vaksineres. 1 dose (1 ml) gis i.m. Grunnimmunisering: 1. injeksjon gis fra 6 måneders alder, 2. injeksjon gis 4 uker senere. Revaksinering: 1. revaksinering (3. dose) gis 5 måneder etter grunnimmuniseringen. Denne revaksineringen fører til immunitet som varer i minst 12 måneder. Den
2. revaksineringen gis 12 måneder etter 1. revaksinering. Alternativt anbefales det å gi, med 12 måneders intervall, en passende vaksine mot hesteinfluensa
som inneholder stammene A/equine 2/South Africa/4/03 og A/equine 2/Newmarket-2/93 for å opprettholde immunitet for influensakomponenten. Ved økt
infeksjonsrisiko eller ved utilstrekkelig inntak av kolostrum, kan det i tillegg gis en initial injeksjon ved 4 måneders alder etterfulgt av det fullstendige vaksinasjonsprogrammet (grunnimmunisering ved 6 måneders alder og 4 uker senere).
Tilbakeholdelsestider: Ingen.
Oppbevaring og holdbarhet: Oppbevares i kjøleskap (2-8°C). Beskyttes mot lys. Skal ikke fryses.
Pakninger: Injeksjonsvæske: Til hest: 10 × 1 ml (ferdigfylt sprøyte) 152943. 10 × 1 ml (hettegl.) 092193. Sist endret: 27.08.2013
Equilis Prequenza Te Intervet/MSD Animal Health
Vaksine mot influensa og tetanus hos hest. ATCvet-nr.: QI05A L01
INJEKSJONSVÆSKE, suspensjon til hest: 1 dose (1 ml) inneh.: Hesteinfluensavirus: A/equine-2/South Africa/4/03 50 AU, A/equine-2/Newmarket/2/93 50 AU,
tetanustoksoid 40 Lf, renset saponin, kolesterol, fosfatidylkolin, fosfatbuffer, spor av tiomersal og formaldehyd.
Egenskaper: Virkningsmekanisme: Stimulerer til aktiv immunisering mot hesteinfluensa, og aktiv immunisering mot tetanus.
Indikasjoner: Aktiv immunisering av hester fra 6 måneders alder mot hesteinfluensa, ved å redusere kliniske symptomer og virusspredning etter infeksjon,
og aktiv immunisering mot tetanus for å hindre dødsfall. Influensa: Begynnende immunitet: 2 uker etter grunnimmunisering. Varighet av immunitet: 5
måneder etter grunnimmunisering, 12 måneder etter 1. revaksinering. Tetanus: Begynnende immunitet: 2 uker etter grunnimmunisering. Varighet av immunitet: 17 måneder etter grunnimmunisering, 24 måneder etter 1. revaksinering.
Bivirkninger: En diffus hard eller bløt hevelse (maks. 5 cm i diameter), som går tilbake innen 2 dager, kan forekomme. I svært sjeldne tilfeller kan det forekomme en lokal hevelse >5 cm som kan vare >2 dager. Smerte på injeksjonsstedet kan forekomme i sjeldne tilfeller og resultere i kortvarig funksjonelt
ubehag (stivhet). I svært sjeldne tilfeller kan feber, noen ganger fulgt av letargi og mangel på appetitt, forekomme i 1 dag, unntaksvis i opp til 3 dager.
Forsiktighetsregler: Pga. mulig interferens med maternelle antistoffer, skal føll ikke vaksineres før ved 6 måneders alder, spesielt føll født av hopper som
ble revaksinert i løpet av de 2 siste månedene av drektigheten.
Interaksjoner: Det finnes sikkerhets- og effektdata som viser at denne vaksinen kan gis på samme dag som, men ikke blandet med, Tetanus-Serum fra
Intervet/MSD Animal Health. Ingen informasjon er tilgjengelig vedrørende sikkerhet og effekt ved bruk sammen med andre preparater. Det må derfor
avgjøres i det enkelte tilfelle om denne vaksinen skal brukes før eller etter andre veterinærpreparater.
Drektighet/Laktasjon: Kan brukes under drektighet og laktasjon.
Dosering: Kun friske dyr skal vaksineres. 1 dose (1 ml) gis i.m. Grunnimmunisering: Første injeksjon gis fra 6 måneders alder, 2. injeksjon gis 4 uker senere.
Revaksinering: Influensa: 1. revaksinering (3. dose) gis 5 måneder etter grunnimmuniseringen. Denne revaksineringen fører til immunitet som varer i minst
12 måneder. Den 2. revaksineringen gis 12 måneder etter 1. revaksinering. Alternativt anbefales det å gi, med 12 måneders intervall, en passende vaksine
mot hesteinfluensa som inneholder stammene A/equine 2/South Africa og A/equine 2/Newmarket-2/93, for å opprettholde immunitet for influensakomponenten. Tetanus: 1. revaksinering gis senest 17 måneder etter grunnimmuniseringen. Deretter anbefales et maks. intervall på 2 år. Ved økt infeksjonsrisiko
eller ved utilstrekkelig inntak av kolostrum, kan det i tillegg gis en initial injeksjon ved 4 måneders alder etterfulgt av det fullstendige vaksinasjonsprogrammet (grunnimmunisering ved 6 måneders alder og 4 uker senere). Samtidig aktiv og passiv immunisering (krisevaksinering): Vaksinen kan brukes sammen med
Tetanus-Serum fra Intervet til behandling av skadede hester som ikke er immunisert mot tetanus. I slikt tilfelle kan den 1. vaksinedosen gis samtidig med
egnet profylaktisk dose Tetanus-Serum fra Intervet, på et separat injeksjonssted, ved bruk av separate sprøyter og kanyler. Dette fører til passiv beskyttelse
mot tetanus i minst 21 dager etter samtidig administrering. Den 2. vaksinedosen administreres 4 uker senere. En 3. vaksinasjon med Equilis Prequenza Te
gjentas minst 4 uker senere. Samtidig bruk av Equilis Prequenza Te og Tetanus-Serum fra Intervet, kan redusere aktiv immunitet mot tetanus sammenlignet
med hester som er vaksinert med Equilis Prequenza Te, uten tetanus-antitoksin-serum.
Tilbakeholdelsestider: Ingen.
Oppbevaring og holdbarhet: Oppbevares i kjøleskap (2-8°C). Beskyttes mot lys. Skal ikke fryses.
Pakninger: Injeksjonsvæske: Til hest: 10 × 1 ml (ferdigfylt sprøyte) 387395. 10 × 1 ml (hettegl.) 037426. Sist endret: 27.08.2013
MSD Animal Health NO2013-08 CA41