A brighter future for dogs with canine melanoma

Canine Melanoma Vaccine, DNA — Label

Indications

The vaccine is indicated for the treatment of dogs with stage II or stage III oral melanoma and for which local disease control has been achieved (negative local lymph nodes or positive lymph nodes that were surgically removed or irradiated).

Dosage

The vaccine is packaged in a box containing four single-dose vials. This package of four vials is sufficient for the initial series of vaccinations required to treat one dog.
The vaccine is administered in a 0.4 mL dose volume using the Canine Transdermal Device. Refer to the device package insert for instructions on vaccinating with the device.
The site of injection for all size dogs is into the muscle of the medial thigh just caudal to the femur.
Initial treatment requires administration of four doses of vaccine at two week intervals.
A booster dose should be administered at six month intervals.

Safety

Safety of the vaccine has been demonstrated by the administration of the label dose to conventional dogs and a limited number of dogs with oral melanoma. Dogs were observed for post-vaccination reactions.
A transient, low-grade fever may be observed in some dogs.
Safety studies in dogs with oral melanoma are ongoing to support full licensure of this vaccine.

Reasonable Expectation of Efficacy

The vaccine is currently distributed under conditional licensure based upon USDA requirements for demonstration of safety and a reasonable expectation of efficacy. Trials to demonstrate efficacy of the product are ongoing and will be based upon the extension of survival time in dogs treated with this product.

Mode of Action

Each dose contains plasmid DNA that expresses the gene coding for human tyrosinase.
Tyrosinase protein is over expressed on melanoma cells.
Upon injection, the DNA is taken up by muscle cells which then express the human tyrosinase protein.
The human tyrosinase protein is different enough from the canine tyrosinase protein that it will stimulate an immune response, yet similar enough to the canine tyrosinase that the immune response is effective against canine melanoma cells which express tyrosinase.

Precautions and contraindications

There are no known contraindications for the use of this product in dogs with oral melanoma.
Store at 2-7°C (35-45°F). Do not freeze. Use entire contents when first opened. Do not use chemicals to sterilize nozzles or adapters.
In rare instances, administration of vaccines may cause lethargy, fever, and inflammatory or hypersensitivity types of reactions. Treatment may include antihistamines, anti inflammatories, and/or epinephrine.

For Veterinary Use Only.

NOTICE: The USDA has issued a conditional U.S. Veterinary Biological Product License for this therapeutic vaccine. This conditional license is a response to an application and assurance of safety and purity, and a reasonable expectation of efficacy based on initial trials.^1,2

During this period of conditional license, additional research will be conducted to further support the safety and efficacy of the vaccine. Production under this license is in compliance with all regulations and standards applicable to such products.

¹Bergman PJ, et al. Development of a xenogeneic DNA vaccine program for canine malignant melanoma at the Animal Medical Center. Vaccine 2006;24:4582-4585.
²Bergman PJ, et al. Long-Term Survival of Dogs with Advanced Malignant Melanoma after DNA Vaccination with Xenogeneic Human Tyrosinase: A Phase I Trial. Clinical Cancer Research 2003;9:1284-1290.