Investigational Immunotherapy Vaccine as Treatment for Canine Atopic Dermatitis

***Enrollment CLOSED***

The University of Florida College of Veterinary Medicine is currently recruiting dogs diagnosed with atopic dermatitis for a clinical research trial to test an investigational vaccine.

Enrollment Status: Closed Enrollment

• Inclusion Criteria:  Any dog <10years old with atopic dermatitis or itchy skin without concurrent infection.  Not taking antibiotics, prednisone, Apoquel, atopica (cyclosporin) or glucocorticoids at the time of screening.
• Treatment: Participation includes 1 enrollment/vaccination visit and follow up vaccination visits at 3 weeks and 6 weeks and recheck visits at 60 days, 90 days, and 6 months. Complete dermatological examinations will be performed at each visit.  This is a controlled study, dogs may be assigned to the Treatment group or a Placebo group.  The study does allow the use of medications to treat pyoderma like antibiotiocs or prednisone after the vaccine has been initiated.
• Costs: The study will cover the costs associated with  each visit for this trial.   The investigational vaccine will be provided at no cost.  Owners will be responsible for medications to treat pyoderma (antibiotics and prednisone) if a skin infection appears during the course of the study. Owners will be required to maintain their animal on a stable flea/tick prevention protocol and to maintain their diet and environment throughout the duration of the trial.
• Costs for compassionate:  Owners will be responsible for vaccine and medications to treat pyoderma (antibiotics and prednisone) if a skin infection appears during the course of the study. Owners will be required to maintain their animal on a stable flea/tick prevention protocol and to maintain their diet and environment throughout the duration of the trial.
• Contact: You can contact our Small Animal Hospital at (352) 392-2235 to schedule an appointment with Dermatology. Study Interest Form
• PI: Dr. Domenico Santoro

Background:

Many therapeutic options have been proposed and studied in allergic dogs. Allergen specific immunotherapy (ASIT) is considered the gold standard for long term management for allergic dogs, but its efficacy is not achieved for several months requiring additional treatments to control allergic patients. Corticosteroids are frequently prescribed to control symptoms while waiting for ASIT to reach full efficacy. However, both treatment options can be harmful or very expensive in long term. Very recently, the use of heat-killed actinomycetales has shown potential beneficial effects on canine allergies. The purpose of this placebo controlled study is to evaluate the clinical beneficial effects of heat-killed actinomycetales in allergic dogs. The study is designed to show if there is improvement in the clinical signs in dogs with allergies in a short period of time. The injected heat-killed bacteria will stimulate an inflammatory response that will lead to a shift in the local and systemic immunological response to external allergens.