Canine malignant melanoma is an aggressive cancer derived from the pigment-producing cells, called melanocytes. This disease is particularly common in dogs, frequently appearing in the mouth as oral malignant melanoma or on the toes as digital melanoma. Because of its tendency to spread rapidly to other parts of the body, treatment often requires more than just local removal of the tumor.
Defining the Therapeutic Goal
The melanoma vaccine, known commercially as ONCEPT® Canine Melanoma Vaccine, DNA, is classified as a therapeutic treatment, not a preventative measure like a typical annual shot. It is designed for dogs already diagnosed with melanoma and works as a form of immunotherapy, harnessing the dog’s own immune system to target and destroy remaining cancer cells.
This approach is considered an adjunct therapy, meaning it is used in addition to conventional methods like surgery or radiation. The vaccine is not intended to cure the disease but rather to extend the life and improve the quality of life for the affected dog. The USDA has licensed the vaccine for use in dogs with Stage II or Stage III oral malignant melanoma, where local control of the primary tumor has been achieved. Stage II and III melanomas are characterized by tumors that are larger than two centimeters or have already spread to the local lymph nodes.
The challenge with many cancers is that the body’s immune system often fails to recognize the tumor cells as foreign and dangerous. Melanoma cells are often particularly adept at hiding from immune surveillance. The therapeutic goal of this unique vaccine is to break that tolerance, teaching the immune system to see and attack the cancerous melanocytes.
The Mechanism of Action
The biological mechanism of the ONCEPT vaccine is based on a concept called xenogeneic immunization. The vaccine itself is a piece of specially engineered, circular DNA known as a plasmid. This plasmid DNA is injected into the dog, where it is taken up by muscle cells near the injection site.
The DNA within the vaccine codes for human tyrosinase, an enzyme found in melanocytes. Tyrosinase is responsible for producing melanin and is significantly overexpressed by melanoma tumor cells in both dogs and humans. After the dog’s muscle cells absorb the plasmid, they begin producing the human tyrosinase protein.
The dog’s immune system recognizes this human protein as foreign because it differs slightly from the dog’s native tyrosinase. This triggers a strong, comprehensive immune response, activating specialized white blood cells called T-cells. These T-cells are trained to attack any cell producing the foreign human tyrosinase. Crucially, the human and canine tyrosinase proteins share enough structural similarity that the T-cells’ strong reaction “cross-reacts.”
The activated immune cells then turn their attention to the dog’s own melanoma cells, which are overproducing the similar canine tyrosinase enzyme. The T-cells begin to seek out and destroy these cancer cells throughout the body, providing a systemic defense against the disease. This results in the initiation of a robust, tumor-specific immune memory that continues to patrol the body for residual or newly emerging cancer cells.
Treatment Protocol and Managing Side Effects
The initial treatment series involves four separate doses, administered every two weeks. This intensive early schedule is designed to repeatedly introduce the foreign tyrosinase DNA, building a potent and long-lasting immune memory against the cancer.
The vaccine is delivered using a specialized device, the VET JET® transdermal vaccination system, which uses high pressure instead of a needle. The device injects the vaccine directly into the muscle of the inner thigh. Following the initial four-dose induction phase, dogs require a booster dose every six months for the rest of their lives to sustain the immune response.
The vaccine is generally well-tolerated. The most common side effects are transient and localized to the injection site, including mild pain, localized swelling, or a temporary redness shortly after the procedure.
Systemic side effects are typically mild and short-lived, potentially including a low-grade fever or a brief period of lethargy. These reactions are generally a sign that the dog’s immune system is actively responding to the vaccine. The vaccine is usually administered by a veterinary oncologist or a specialist who can monitor the overall cancer treatment plan.
The efficacy of the vaccine is measured by its ability to extend the median survival time for dogs with Stage II or III oral melanoma. When used in conjunction with local control, the vaccine can significantly prolong survival, often to twelve months or more, compared to only a few months with surgery alone. The cost of the treatment varies widely but represents a significant, long-term financial commitment.

