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Vanguard Plus 5 ®
VANGUARD® PLUS 5
Pfizer Animal
Vaccine
Canine Distemper-Adenovirus Type 2-Parainfluenza-Parvovirus
Vaccine, Modified Live Virus
Description: VANGUARD® Plus 5 contains attenuated strains of CD
virus, CAV-2, CPI virus, and CPV propagated on an established
canine cell line. The CPV fraction is high titer (107.0
TCID50/dose) and was attenuated by low passage (35 passes from
the canine isolate with a maximum of 2 additional passes allowed
for production) on the canine cell line which gives it the
immunogenic properties capable of overriding maternal antibody
interference at the levels indicated in Table 2. Some puppies in
the field may have higher levels of maternal antibodies than
those evaluated in our pivotal efficacy study. VANGUARD® Plus 5
is packaged in freeze-dried form with inert in place of
vacuum.
Contains penicillin and streptomycin as preservatives.
Indications: VANGUARD® Plus 5 is for vaccination of y
dogs 6 weeks of age or older as an aid in preventing canine
distemper caused by canine distemper (CD) virus, infectious
canine hepatitis (ICH) caused by canine adenovirus type 1
(CAV-1), respiratory disease caused by canine adenovirus type 2
(CAV-2), canine parainfluenza caused by canine parainfluenza
(CPI) virus, and canine parvoviral enteritis caused by canine
parvovirus (CPV).
Directions: 1. General Directions: Vaccination of y dogs
is recommended. Aseptically rehydrate the freeze-dried vaccine
with the sterile diluent provided, shake well, and administer 1
mL subcutaneously or intramuscularly.
2. Primary Vaccination: y dogs 6 weeks of age or older
should receive 3 doses, each administered 3 weeks apart.
3. Revaccination: Annual revaccination with a single dose is
recommended.
Precaution(s): Store at 2°-7°C. Prolonged exposure to higher
temperatures and/or direct sunlight may adversely affect potency.
Do not freeze.
Use entire contents when first opened.
Sterilized syringes and needles should be used to administer
this vaccine. Do not sterilize with s because traces of
disinfectant may inactivate the vaccine.
Burn containers and all unused contents.
Caution(s): Vaccination of pregnant bitches should be avoided.
As with many vaccines, anaphylaxis may occur after use. Initial
antidote of epinephrine is recommended and should be followed
with appropriate supportive therapy.
This product has been shown to be efficacious in y
animals. A protective immune response may not be elicited if
animals are incubating an infectious disease, are malnourished or
parasitized, are stressed due to shipment or environmental
conditions, are otherwise immunocompromised, or the vaccine is
not administered in accordance with label directions.
For use in dogs only.
Warning(s): For veterinary use only.
Discussion: Disease Description: CD is a universal,
high-mortality viral disease with variable manifestations.
Approximately 50% of nonvaccinated, nonimmune dogs infected with
CD virus develop clinical signs, and approximately 90% of those
dogs die.1 ICH, caused by CAV-1, is a universal, sometimes al,
viral disease of dogs characterized by hepatic and generalized
endothelial lesions. CAV-2 causes respiratory disease which in
severe cases may include pneumonia and bronchopneumonia. CPI is a
common viral upper respiratory disease. Uncomplicated CPI may be
mild or subclinical, with signs becoming more severe if
concurrent infection with other respiratory pathogens exists. CPV
infection results in enteric disease characterized by sudden
onset of vomiting and diarrhea, often hemorrhagic. Leukopenia
commonly accompanies clinical signs. Susceptible dogs of any age
can be affected, but mortality is greatest in puppies. In puppies
4-12 weeks of age CPV may occasionally cause myocarditis that can
result in acute heart failure after a brief and inconspicuous
illness. Following infection many dogs are refractory to the
disease for a year or more. Similarly, seropositive bitches may
transfer to their puppies CPV antibodies which can interfere with
active immunization of the puppies through 16 weeks of age.
Trial Data: Safety and Efficacy: Laboratory evaluation
demonstrated that VANGUARD® Plus 5 immunized dogs against CD,
ICH, CAV-2 respiratory disease, CPI, and CPV, and that no
immunologic interference existed among the vaccine fractions.
Extensive field safety trials conducted by Pfizer Animal
showed it to be safe and reaction-free in dogs as young as 6
weeks of age under normal usage conditions.
It has been demonstrated that CAV-2 vaccine cross-protects
against ICH caused by CAV-1. The CAV-2 fraction in Vanguard
vaccines is used as a replacement for CAV-1 because it has
significant advantages. Some CAV-1 vaccines may produce
undesirable reactions, including persistent kidney infections,
uveitis, and corneal opacity (Âblue eyeÂ), which have not been
reported after vaccination with CAV-2.2 In addition, the CAV-2
strain used in Vanguard® vaccines has been specially selected
for freedom from oncogenic properties characteristic of
adenoviruses.
Studies conducted at Pfizer demonstrated that CAV-2 not only
protects against ICH, but against CAV-2 respiratory disease as
well.3 Although conventional CAV-1 (ICH) vaccines cross-protect
against CAV-2, they may not prevent subclinical infection and
spread of the CAV-2 agent. Canine adenovirus type 2 challenge
virus was not recovered from CAV-2-vaccinated dogs in tests
conducted at Pfizer.
The CPV fraction in VANGUARD® Plus 5 was subjected to
comprehensive safety and efficacy testing at Pfizer. It was shown
safe and reaction-free in laboratory tests and in clinical trials
under field conditions. Product safety was further demonstrated
by a backpassage study which included oral administration of
multiple doses of the vaccine strain to susceptible dogs, all of
whom remained normal. The CPV virus in VANGUARD® Plus 5 shares a
characteristic with other live CPV vaccine strains in that the
vaccine virus may be present in the feces following
administration. Although this CPV vaccine virus was found
occasionally and in low titers in the feces of vaccinated dogs,
testing demonstrated that the vaccine master seed did not revert
to virulence following 6 consecutive backpassages in susceptible
dogs.
Table 1. Initial Serum Neutralization (SN) Titers of Vaccinates
and Controls
SN Titers
# Vaccinates Included
# Controls Included
<1:2
3
0
 1:4
4
3
 1:8
1
3
 1:16
4
1
 1:32
2
5
 1:64
3
1
 1:128
6
3
 1:256
2
3
 1:512
0
5
 1:1024
0
1
Table 2. Postvaccination Serum Neutralization (SN) Titers
Geometric Mean (Range)a
Groups
N
Pre-vaccination
Postvaccination
1
2
3b
All Vaccinated Dogs
25
1:24
(<2-256)
1:108
(8-1024)
1:605
(8-4096)
1:1176
(128->4096)
Responders Post 1st Vac.
13
1:6
(<2-64)
1:460
(64-1024)
1:1745
(256-4096)
1:1410
(256-4096)
Responders Post 2nd Vac.
 9
1:87
(16-256)
1:20
(8-64)
1:376
(256-1024)
1:1625
(256-4096)
Responders Post 3rd Vac.
 3
1:128
(128)
1:32
(16-64)
1:25
(8-64)
1:203
(128-256)
Nonvaccinated Control Dogs
25
1:64
(4-1024)
1:9
(<2-64)
1:3
(<2-64)
<1:2
(<2-4)
a Dogs were vaccinated at 6, 9, and 12 weeks of age.
b Pre-challenge SN titers
Research at Pfizer demonstrated that 3 doses of the vaccine with
increased CPV virus titer can overcome serum neutralization (SN)
titers associated with maternal antibody. Serum neutralization
titers as low as 1:4 have been shown by others to interfere with
active immunization using conventional modified live vaccines.4,5
A clinical trial was conducted with fifty 6-week-old puppies [25
vaccinates (SN titer range -256) and 25 nonvaccinated controls
(SN titer range 4-1024)] (Table 1). The group of vaccinates
received 3 doses, with vaccinations administered 3 weeks apart
beginning at 6 weeks of age. After 1 vaccination, 13/25 puppies
exhibited a 4-fold or greater increase in CPV SN titer
(seroconversion) (Table 2). Twelve of these 13 puppies had
maternal SN titers ?1:16 at the time of the first vaccination
with the remaining puppy having an SN titer of 1:64. Another 9
puppies with initial SN titers between 1:16 and 1:256
seroconverted after the second vaccination. Their maternal
antibody SN titers had declined to ?1:64 at the time of the
second vaccination. Similarly, the last 3 vaccinates, with
initial SN titers of 1:128, seroconverted after the third
vaccination, after their maternal antibody CPV titer dropped
?1:64. Therefore, in this study, when 3 doses of vaccine were
given beginning at 6 weeks of age, all 25 vaccinates, even those
with the highest maternal antibody levels, became actively
immunized (GM = 1:1176; range of SN titers 128-4096). All 50 dogs
were challenged 3 weeks after the third vaccination with a
heterologous CPV challenge virus. Fourteen of 25 nonvaccinated
control dogs died or showed illness severe enough to warrant
euthanasia, while all 25 vaccinates remained essentially y.
The high-titer, low-passage vaccine virus in VANGUARD® Plus 5 is
therefore highly immunogenic and capable of stimulating active
in the presence of maternal antibodies.
