Veterinary Medical Center

Study is opening soon. If you have a potential patient that maybe eligible for enrollment please contact Dr. Hillier (hillier [dot] 4 [at] osu [dot] edu).

Purpose: 

 The purpose of this study is to evaluate whether this vaccine reduces the clinical signs and pruritus associated with canine atopic dermatitis.

Background: 

The targeted cytokine has been implicated in the pathogenesis of atopic dermatitis in humans. It has been shown that vaccination of beagles and mongrels against the targeted cytokine elicits an antibody response detectable by enzyme-linked immunosorbent assay (ELISA).  More importantly, the elicited antibodies block the in vitro activity of the targeted cytokine. 

Study Design:

The objective of this study is to evaluate the effect of a key cytokine involved in canne atopic dermatitis on the severity of clinical signs associated with atopic dermatitis in client-owned dogs.  For this purpose, a group of 20 dogs will be vaccinated 4 times, at a 21 day-interval, with the vaccine (250 µg/dose) adjuvanted with 15% Emulsigen.  A second group of 20 dogs will be vaccinated 4 times with a placebo containing the same adjuvant. The vaccine and placebo will be administered as a 1-mL dose by subcutaneous route. Sera will be collected from all animals at regular intervals.  The antibody response against the cytokine will be evaluated in collected sera using antigen-specific ELISA.  Sera will also be tested for their capacity to block the  activity of the cytokinein an in vitro cell proliferation assay. The primary measures of vaccine efficacy will be based on statistical evaluation of 1) reduction of atopic dermatitis skin lesion scores, as measured by a decrease from baseline of Veterinarian’s assessed lesions and 2) reduction of pruritus, as measured by a decrease from baseline of owner’s assessed scores. 

Inclusion criteria:

The study will enroll client-owned dogs with a history of nonseasonal or seasonally non-seasonal Atopic Dermatitis. To be included in the trial, dogs must fulfill the following criteria:

1. Owner’s written informed consent has been obtained.
2. At least 18 months of age at start of trial.
3. History of non-seasonal or seasonally non-seasonal pruritus.
4. Clinical diagnosis of atopic dermatitis.
5. Incomplete response to a minimum 6-week hydrolyzed diet or novel protein exclusion diet (home cooked or commercial). Dogs should be stabilized on a diet for at least two weeks prior to enrollment in the study and this diet should be maintained throughout the trial.
6. Incomplete response to a regulatory approved flea control regimen for at least 8 weeks.  Regardless of whether there is an element of flea allergy dermatitis (FAD), monthly flea control must be maintained throughout the trial.
7. Dogs must be on a regulatory approved endoparasite control program, including heartworm for at least 8 weeks and must continue this program throughout the trial.(All study particiapants will have Advantage Multi)
8. Sarcoptic mange excluded by trial therapy, negative serology, or history and clinical signs.
9. Within 30 days prior to study initiation, demonstrate immediate positive skin reactions upon intradermal testing with environmental allergens such as house dust mites, pollens, or molds or exhibit high serum concentration of allergen-specific IgE.
10. No clinical signs suggestive of overt surface, superficial, or deep microbial skin infection (i.e. bacterial pyoderma and Malassezia dermatitis) at the time of entry. Dogs with bacterial or fungal skin infection are eligible for inclusion in the study only after resolution of their infections.
11. Dogs must exhibit cytokine or cytokine receptor mRNA in biopsies obtained from their lesional skin.
12. Baseline Pruritus Visual Analog Score (PVAS) of > 4.
13. Allergen-specific immunotherapy is permitted if used for >12 months, the dose remains unchanged for 6 months, the clinical signs are stable and the regimen is maintained during the trial.
14. Essential fatty acid supplementation to diets is permitted if in use for > 8 weeks, the clinical signs are stable and the dosing regimen is maintained during the trial.

Exclusion Criteria:

Dogs with the following criteria or conditions will be excluded from the study:

1. Pregnancy, lactation or breeding activity.
2. Evidence of underlying disease that may compromise the study outcome.
3. Disease history and results of diagnostic testing are not clearly documented.
4. Dogs not using a regulatory approved flea control and endoparasite (including heartworm) control regimens.
5. Diet changes during the trial.
6. Use of anti-inflammatory drugs other than those allowed by protocol.
7. Allergen-specific immunotherapy discontinued within 6 months or initiated within 12 months prior to enrollment.
8. Initiated or discontinued essential fatty acid supplementation within 8 weeks.
9. Clinical evidence of active ectoparasite infestation.
10. Clinical evidence of active bacterial or fungal skin infections.

Client Compensation:

• Study covers the costs associated with the study at each visit
• Advantage Multi for Dogs will be supplied during the study

Client Cost:

• Clients that complete the study will have a credit of $300 to be used at the OSU Veterinary Medical Center

Contact:   Dr. Hillier (hillier [dot] 4 [at] osu [dot] edu) or Nicole Stingle (ClinicalTrials [at] cvm [dot] osu [dot] edu)