Recombitek C3 (Canada)

Company: Boehringer Ingelheim Animal Health

rDAP SWD

Dogs

1 mL

Canine Distemper-Adenovirus Type 2-Parvovirus Vaccine

Modified Live Virus, Canarypox Vector

See productdata.aphis.usda.gov for summary of the studies approved by the USDA for licensing this product. The package insert also contains additional information developed by the licensee.

Description

Recombitek^® C3 contains a lyophilized suspension of a recombinant canarypox vector expressing the HA and F glycoproteins of canine distemper virus; modified live adenovirus type 2, and parvovirus; plus sterile water diluent. Safety and immunogenicity of this product have been demonstrated by vaccination and challenge tests in susceptible dogs.

Recombitek C3 Indications

This product has been shown to be effective for the vaccination of healthy dogs 6 weeks of age and older against canine distemper virus, canine adenovirus type 1 (canine hepatitis), canine adenovirus type 2 (canine respiratory disease complex), and canine parvovirus. The duration of immunity has not been determined. For more information regarding efficacy and safety data, see productdata.aphis.usda.gov.

Directions and dosage: Aseptically rehydrate the lyophilized vaccine with the accompanying liquid diluent, and agitate. Administer 1 mL (1 dose) subcutaneously or intramuscularly into healthy dogs. For primary vaccination, revaccinate with a second 1 mL dose 2 to 3 weeks later. The presence of maternal antibody is known to interfere with the development of active immunity in dogs and additional boosters will be required in most young animals. For advice on revaccination frequency, consult your veterinarian.

Precautions

Store at 2-8°C (35-46°F). Do not use chemicals to sterilize syringes and needles. Do not mix with other products, except as specified on the label. Use entire contents immediately after reconstitution. Contains gentamicin as a preservative. In rare instances, administration of vaccines may cause lethargy, fever, and inflammatory or hypersensitivity types of reactions. Transient lethargy, as well as pain and swelling at the site of injection, may occur following use of this product. Treatment may include antihistamines, anti-inflammatories, and/or epinephrine, as directed by a veterinarian. This product has not been tested in pregnant animals. In case of human exposure, contact a physician. Inactivate unused contents before disposal.

For use in animals only. Sold to veterinarians only.

Duration of serologic response studies: Vaccination with Recombitek^® canine distemper combination vaccines, under controlled-exposure and field conditions, has been demonstrated to result in serum antibody titers that persist for at least 36 months against canine distemper virus (CDV), canine parvovirus type 2 (CPV-2), and canine adenovirus type 1 (CAV-1).

Adaptive immunity: Stimulation of the adaptive immune response, following infection or vaccination, involves humoral (antibody) and cell-mediated immunity (CMI). Specifically, the immune system produces antigen-specific T and B cells, including effector cells for immediate protection and memory cells for long-term protection. When exposed to the same pathogen (antigen) in the future, memory T and B cells as well as the antibodies from memory effector B cells interact to provide protection. Vaccination, depending on the vaccine and the disease, may stimulate sterilizing immunity, meaning there are enough pre-existing antibodies present to prevent or significantly limit infection, precluding the development of clinical disease. In other cases, vaccination does not prevent infection but does limit infection and/or clinical disease through a complex interaction of local and systemic CMI and humoral immunity, including local antibodies.¹

Serological tests are available to measure antibody titers following exposure to a pathogen (antigen) through infection or vaccination. For some infectious diseases, including canine distemper, canine parvovirus and canine adenovirus, serum antibody titers can provide valuable diagnostic information when determining an individual animal’s immune status.^2,3 Serologic testing that correlates with immunity by challenge studies include the serum virus neutralization (SVN) test for canine distemper and canine parvovirus and the hemagglutination inhibition (HI test performed with porcine or monkey erythrocytes) for canine parvovirus.^1,2,3 Considering the complex interaction of CMI and humoral immunity and the variability of host-animal response to vaccination (serologic titer) and/or challenge (strain and magnitude), serology alone is not always predictive of protection or lack of protection against disease. Determination of an appropriate vaccination protocol depends upon a thorough understanding of the disease, the vaccine, the patient’s lifestyle and risk of exposure, and serology when appropriate.^1,2

Controlled exposure study: A controlled-exposure study, consisting of 51 CDV-seronegative beagle puppies, housed in a CPV-2 disease-free environment where CAV-2 virus was known to be present, was conducted. Sentinel puppies were housed in the same facility throughout the study and serologically tested for CDV annually to ensure the facility remained CDV-free. Puppies from 37 different litters were randomly assigned to be vaccinated with Recombitek C4 in each of 4 separate groups. Vaccination of the puppies in each group was initiated on four different dates. All puppies in each of the vaccinated groups received two doses of Recombitek C4 at 12 to 13 weeks of age (first vaccination) and 15 to 17 weeks of age (second vaccination). Puppies in Group 1 (n=14) and Group 2 (n=16) were revaccinated at 1 year of age. Puppies in Groups 3 (n=10) and 4 (n=11) were not revaccinated after receiving the initial 2 doses. Sera were collected from all dogs 36 to 48 months after the final vaccination and were assayed for the presence of CDV and CAV-1 antibody titers using serum viral-neutralizing (SVN) assays and CPV-2 antibody titer using hemagglutination inhibition (HI). All samples were assayed by the RD Schultz Laboratory, School of Veterinary Medicine, University of Wisconsin; Madison, WI, ensuring standardized tests methods were used. The results provided below in Table 1 demonstrate a sustainable elevation in geometric mean (log₂) titers for a minimum of 36 to 48 months following the last vaccination.

Table 1. Geometric Mean log₂ titers induced by Recombitek C4 (Controlled exposure study)

Conclusion: As shown in the table above, Recombitek C4 is capable of inducing a sustained serologic antibody titer response to CDV, CPV-2 and CAV-1 for a minimum of 48 months following the last vaccination. The environment in which the dogs were housed was free of CPV-2, and the sentinel dogs remained CDV negative, indicating CPV-2 and CDV titers were induced by vaccination alone. The CAV-1 serologic antibody titer response may reflect response to vaccination and/or environmental exposure.

Multi-center field study: This study was a multi-center hematological survey of client-owned dogs of various breeds seen for routine care at 5 veterinary clinics located in the United States that used Recombitek exclusively. All dogs had been previously vaccinated with Recombitek C4 and/or C6/CV vaccines and had not been revaccinated within the prior 10 to 67 months. Dogs were grouped according to their vaccination interval (time since the last vaccination), which ranged from 10 to 67 months. The vaccination intervals evaluated were as follows: < 14 months, 15 to 26 months, 27 to 32 months, 33 to 38 months, and greater than 39 months. All samples were assayed by the RD Schultz Laboratory, School of Veterinary Medicine, University of Wisconsin; Madison, WI. Two-hundred-thirty-nine (239) serum samples from 4 different sites were batched and tested for CDV antibody titers (SVN). The CDV geometric mean titers (log₂) are shown below in Table 2. Three-hundred-twenty-six (326) serum samples from 5 different sites were assayed for CPV-2 antibody titers (HI). From the 326 samples assayed for CPV-2 titers a subset of 142 samples were randomly selected and assayed for CAV-1 antibody titers (SVN).

The CPV-2 and CAV-1 geometric mean titers (log₂) are shown below in Tables 3 and 4, respectively.

Table 2. CDV Geometric Mean log₂ Titers Induced by Recombitek C4 and/or C6/CV

Table 3. CPV-2 Geometric Mean log₂ Titers Induced by Recombitek C4 and/or C6/CV

Table 4. CAV-1 Geometric Mean log₂ Titers Induced by Recombitek C4 and/or C6/CV

Conclusions: The multi-center field study demonstrated Recombitek^® C6/CV and Recombitek C4 are capable of inducing sustained serologic antibody titer responses to CDV, CPV-2 and CAV-1 for a minimum of 39 months. Since the study was conducted under field conditions with client-owned animals, the antibody titers could be the result of vaccination and/or natural environmental exposure to the infectious agents. However, the study demonstrates expected vaccine performance under conditions of intended use.

References

1. Paul MA, Appel M, Carmichael LE, et al. Report of the American Animal Hospital Association (AAHA) Canine Vaccine Task Force: 2003 Canine Vaccine Guidelines, Recommendations, and Supporting Literature.

2. American Animal Hospital Association Web site. 2006 AAHA Canine Vaccine Guidelines, Revised. Available at: http://www.aahanet.org/PublicDocuments/VaccineGuidelines06Revised.pdf. Accessed August 11, 2008.

3. Greene, CE, Schultz, RD. Immunoprophylaxis. In: Greene CE, ed. Infectious Diseases of the Dog and Cat. 3rd edition. St. Louis: Saunders Elsevier, 2006; 1084.

Manufactured by:

Boehringer Ingelheim Animal Health USA Inc., Athens, GA 30601 USA

Phone: 1 (888) 637-4251

VLN/PCN 124/1331.R1

Distributed in Canada by:

Boehringer Ingelheim Animal Health Canada Inc., Burlington ON L7L 5H4

Recombitek^® is a registered trademark in the USA of Boehringer Ingelheim Animal Health USA Inc.

Recombitek^® is a registered trademark in Canada of Boehringer Ingelheim Vetmedica GmbH. Used under license.

RM2062R2

CPN: 1182116.3