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).
The purpose of this study is to evaluate whether
this vaccine reduces the clinical signs and pruritus associated with canine
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.
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.
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:
- Owner’s written informed consent has been
- At least 18 months of age at start of trial.
- History of non-seasonal or seasonally
- Clinical diagnosis of atopic dermatitis.
- 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.
- 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.
- 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
- Sarcoptic mange excluded by trial therapy,
negative serology, or history and clinical signs.
- 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.
- 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.
- Dogs must exhibit cytokine or cytokine
receptor mRNA in biopsies obtained from their lesional skin.
- Baseline Pruritus Visual Analog Score (PVAS)
of > 4.
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.
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
the following criteria or conditions will be excluded from the study:
- Pregnancy, lactation or breeding activity.
- Evidence of underlying disease that may
compromise the study outcome.
- Disease history and results of diagnostic
testing are not clearly documented.
- Dogs not using a regulatory approved flea
control and endoparasite (including heartworm) control regimens.
- Diet changes during the trial.
- Use of anti-inflammatory drugs other than
those allowed by protocol.
- Allergen-specific immunotherapy discontinued
within 6 months or initiated within 12 months prior to enrollment.
- Initiated or discontinued essential fatty
acid supplementation within 8 weeks.
- Clinical evidence of active ectoparasite
evidence of active bacterial or fungal skin infections.
covers the costs associated with the study at each visit
Multi for Dogs will be supplied during the study
- 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)