Vanguard 5/L (Canada)

Manufacturer: Pfizer

Canine Distemper-adenovirus Type 2-parainfluenza-parvovirus Vaccine

Modified Live Virus

Leptospira Canicola-icterohaemorrhagiae Bacterin

For use in dogs only

Product Description

Vanguard 5/L is for vaccination of healthy dogs 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, canine parvoviral enteritis caused by canine parvovirus (CPV), and leptospirosis caused by Leptospira canicola and L. icterohaemorrhagiae. The vaccine component of Vanguard 5/L contains attenuated strains of CD virus, CAV-2, CPI virus, and CPV propagated in an established canine cell line. The CPV fraction was attenuated by low passage in the canine cell line and at that passage level has immunogenic properties capable of overriding maternal antibodies. Some puppies in the field may have higher levels of maternal antibodies than those evaluated in our pivotal efficacy study. The vaccine is packaged in freeze dried form with inert gas in place of vacuum. The bacterin component, containing inactivated whole cultures of L. canicola and L. icterohaemorrhagiae is supplied as diluent.

Disease Description

CD is a universal, high-mortality 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 fatal, 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 the 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. Leptospirosis occurs in dogs of all ages, with a wide range of clinical signs and chronic nephritis generally following acute infection. Infection with L. canicola and L. icterohaemorrhagiae cannot be differentiated clinically.

Safety And Efficacy

Laboratory evaluation demonstrated that Vanguard 5/L aided in preventing CD, ICH, CAV-2 respiratory disease, CPI, CPV enteritis, and leptospirosis caused by L. canicola and L. icterohaemorrhagiae, and that no immunological interference existed among the vaccine fractions.

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 (“blue eye”), 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 demonstrated that the CAV-2 fraction in Vanguard 5/L not only aids in preventing ICH, but 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.

The CPV fraction in Vanguard 5/L was subjected to comprehensive safety and efficacy testing. It was shown safe and reaction-free in laboratory tests and in clinical trials under field conditions. Product safety was demonstrated by oral administration of multiple doses of the vaccine strain to susceptible dogs, which remained normal. The CPV virus in Vanguard 5/L shares a characteristic with other live CPV vaccine strains in that the vaccinal virus may be present in the feces following administration. Although this CPV vaccinal virus was found occasionally and in low titers in the feces of vaccinated dogs, testing demonstrated that the vaccine strain did not revert to virulence following six consecutive backpassages in susceptible dogs.

Susceptible test dogs all developed CPV antibody titers after vaccination and were protected following oral administration of virulent CPV. Conversely, after challenge exposure, nonvaccinated control dogs all developed clinical signs of CPV enteritis, including vomiting and diarrhea with blood and mucous in the feces. Challenge virus was isolated from the feces of five of five control dogs, but only 1/20 vaccinates, and all controls developed marked lymphopenia, while lymphopenia was not demonstrated in vaccinates.

Further research demonstrated a stronger correlation of CPV immunogenicity to number of attenuating virus passages than to antigenic mass; immunogenicity of the vaccinal strain was shown to decline as the number of passages increased. The low-passage vaccinal virus in Vanguard 5/L is therefore highly immunogenic and capable of stimulating active immunity in the presence of maternal antibodies at the levels shown in Table 1. Studies demonstrating that capability involved forty-one 6- to 8-week old puppies (32 vaccinates and 9 controls) with the range of maternal antibody titers shown in Table 2. By 14 days after vaccination, 91% of vaccinates' titers were well above the protective threshold. By 21 days, all dogs, including the dog with the initial SN titer of 1:64 seroconverted, giving a group seroconversion rate of 100%. In contrast, seropositive sentinel littermate dogs' CPV antibody titers declined, demonstrating that initial antibody titers were indeed of maternal origin and no adventitious exposure occurred during the study.

Table 1. Pre- And Postvaccination Serum Neutralization (sn) Titers

number Of Dogs	Prevaccination	Postvaccination
		7 Days	14 Days	21 Days
5	2	39.2	768.0	1433.6
2	4	3.0	36.0	192.0
11	8	45.1	457.5	488.7
9	16	33.8	263.1	739.6
4	32	40.0	450.0	640.0
1	64	32.0	32.0	128.0
Average	13.8	37.3	410.8	696.0

Table 2. Initial Serum Neutralization (sn) Titers Of Vaccinates And Controls.

sn Titers	# Vaccinates Included	# Controls Included
1:2	5	0
1:4	2	1
1:8	11	2
1:16	9	4
1:32	4	2
1:64	1	0

Directions

1. General Directions: Vaccination of healthy dogs is recommended. Aseptically rehydrate the freeze-dried vaccine (Vanguard 5) with the liquid bacterin provided (Leptoferm™ C-I), shake well, and administer 1 mL subcutaneously or intramuscularly.

2. Primary Vaccination: Healthy dogs should receive 2 doses administered 3-4 weeks apart. If dogs are vaccinated before the age of 4 months, they should be revaccinated with a single dose upon reaching 4 months of age. (Maternal antibodies may interfere with development of an adequate immune response in puppies of less than 4 months old.)

3. Revaccination: Annual revaccination with a single dose is recommended.

Precautions

1. Store at 2°-7°C. Prolonged exposure to higher temperatures and/or direct sunlight may adversely affect potency. Do not freeze.

2. Use entire contents when first opened.

3. Sterilized syringes and needles should be used to administer the vaccine. Do not sterilize with chemicals because traces of disinfectant may inactivate the vaccine.

4. Burn containers and all unused contents.

5. Contains gentamicin as preservative.

6. Vaccination of pregnant bitches should be avoided.

7. As with many vaccines, anaphylaxis may occur after use. Initial antidote of epinephrine is recommended and should be followed with appropriate supportive therapy.

8. This product has been shown to be efficacious in healthy 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.

References

1. Swango LJ: Frequently asked questions about CPV disease. Norden News 58:4-10, 1983.

2. Appel M, Bistner SI, Menegus M: Pathogenicity of low-virulence strains of two canine adenovirus types. Am J Vet Res 34:543-549, 1973.

3. Bass EP, Gill MA, Beckenhauer WH: Evaluation of a canine adenovirus type 2 strain as a replacement for infectious canine hepatitis vaccine. JAVMA 177:234-242, 1980.

Technical inquiries should be directed to Pfizer Animal Health Technical Services, (800) 366-5288 (USA), (800) 461-0917 (Canada).

For veterinary use only

U.S. Patent No. 3,616,203

Canadian Patent 1969 No. 829,277

U.S. Veterinary License No. 189

Pfizer Animal Health, Exton, PA 19341, USA, Div. of Pfizer Inc, NY, NY 10017

75-4983-21

^® Registered trademark of Pfizer Products Inc; Pfizer Canada Inc., licensee

Presentation

Cartons of 25 x 1 dose vials.

Nac No.

11981122