Canine Melanoma Vaccine, DNA — Summary of Benefits
Discuss these benefits with your veterinarian.
- Efficacy — 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).1 The conditional license was granted based on the reasonable expectation that when used along with surgery and/or radiation therapy to treat the initial tumor, this vaccine may help extend the survival time of dogs with canine oral melanoma.2,3
- Safety — as part of the conditional license of this vaccine, Merial was required to demonstrate safety and purity, based on initial trials. A temporary, low-grade fever may be observed in some dogs.1
- Dosage — the vaccination is administered in a 0.4 mL dose volume using the Canine Transdermal Device. Four biweekly vaccinations are needed for the initial series. A booster dose should be administered at six-month intervals.
- Needle-free — the Canine Transdermal Device is especially matched to this vaccine for needle-free delivery and optimal distribution of the vaccine.
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.2,3
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.
1Product label.
2Bergman PJ, et al. Development of a xenogeneic DNA vaccine program for canine malignant melanoma at the Animal Medical Center. Vaccine 2006;24:4582-4585.
3Bergman 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. |