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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02311413
Other study ID # DAIT U19-MMU-02
Secondary ID U19AI100266
Status Completed
Phase Phase 2
First received
Last updated
Start date March 9, 2015
Est. completion date July 18, 2018

Study information

Verified date October 2018
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this study is to identify changes in cells that are related to the treatment with Cat-PAD (ToleroMune Cat).


Description:

Cat-PAD is an experimental cat allergy vaccine and has been studied to determine if it can reduce symptom scores of participants exposed to cat allergen. To study how the vaccine causes changes in the immune system, the researchers plan to evaluate changes in the blood (genes and proteins) and urine in response to the Cat-PAD vaccine.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Cat-PAD
The assigned study intervention will be administered by intradermal injection into the flexor surface of the forearm.
Placebo
The assigned study intervention will be administered by intradermal injection into the flexor surface of the forearm.

Locations

Country Name City State
Canada St. Joseph's Healthcare Hamilton Ontario

Sponsors (2)

Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Circassia Limited

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the area under the curve (AUC) from 0 to 6 hour for total nasal symptom score (TNSS). This outcome will be analyzed using analysis of covariance (ANCOVA) where the difference in mean AUC between the untreated and treated groups will be compared while statistically controlling for the effects of the baseline AUC. Following nasal allergen challenge , one year after initiation of peptide immunotherapy.
See also
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Completed NCT02237196 - Anti-TSLP (AMG 157) Plus Antigen-Specific Immunotherapy for Induction of Tolerance in Individuals With Cat Allergy Phase 1/Phase 2
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Terminated NCT01292070 - Safety Evaluation of an Experimental Treatment, Intradermal Human Fcγ1-Fel d1 Fusion Protein (GFD), for Cat Allergy Phase 0
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Completed NCT01033344 - Cat-PAD Exposure Chamber Study Phase 2
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Completed NCT02040844 - Phase III Cat-PAD Follow-on Study Phase 3
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Completed NCT01272323 - Cat-PAD Follow on Study N/A
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