Investigational Immunotherapy Vaccine for Treatment of Feline Hypersensitivity Dermatitis (FHD)

NOTE: This study is on PHASE 2 – Compassionate enrollment ONLY.

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

• Inclusion Criteria:  Any cat  with feline hypersensitivity dermatitis or itchy skin without concurrent infection.  Not taking antibiotics, prednisolone, 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, 6 months, and 1 year. Complete dermatological examinations and blood is drawn at each visit.  This is a controlled study, cats may be assigned to 1 of 2 treatment groups or a Placebo group.  The study does allow the use of medications to treat pyoderma like antibiotiocs or prednisolone after the vaccine has been initiated.
• Costs: 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:

Feline hypersensitivity dermatitis (FHD) is an extremely common skin disease affecting up to 33% cats seen by dermatology specialty practices. Feline hypersensitivity dermatitis includes allergic dermatitis such as flea bite hypersensitivity, cutaneous adverse food reaction, urticarial, angioedema, and feline atopy. Although very common, no many therapeutic options are available for cats with FHD. Available therapeutic options include, but are not limited to, the use of glucocorticoids, allergen specific immunotherapy (ASIT), cyclosporine (CsA), fatty acids, and topical shampoos. As in dogs with atopic dermatitis, ASIT is considered the gold standard for long-term management for feline atopy. However, intradermal test to select specific allergens to formulate the immunotherapy, is very difficult to interpret due to the low grade of reactions. In addition, the efficacy of ASIT is not achieved for several months requiring additional treatments to control atopic cats. CsA and corticosteroids are frequently prescribed to control symptoms of FHD. Corticosteroids, although very effective, are characterized by potentially severe side effects that in some cases can override the benefit of such therapies (e.g. diabetes mellitus). On the opposite, although CsA is characterized by significant fewer side effects than corticosteroids, it is very expensive for long-term management for a chronic disease like feline atopy.

Very recently, the use of heat-killed actinomycetales  as bacterial immunomodulators has shown potential beneficial effects on the canine allergies. Actinomycetales have multiple immunological effects. To date, no studies have been published on the use of such therapy for FHD. Thus, the purpose of this placebo controlled study is to evaluate the clinical and immunological beneficial effects of heat-killed actinomycetales in FHD. It is hypothesized that the use of heat-killed actinomycetales will significantly improve the clinical signs and the pruritus in cats with HD.