Phase 0 study on the safety and allergenicity of a new vaccine for cat allergy
Research type
Research Study
Full title
Title of Study: An open label, safety and allergenicity Phase 0 study of a new hypoallergenic plant-derived cat dander vaccine in adult cat allergic subjects.\nStudy ANG22-01H
IRAS ID
1006294
Contact name
Patrick Colin
Contact email
Sponsor organisation
Angany Inc.
Research summary
Cat allergy is a common problem, causing rhinoconjunctivitis (hay fever-like symptoms) and asthma. Allergen immunotherapy (’desensitisation’) for cat allergy is possible, but the process is time-consuming and carries risks of inducing an allergic reaction. This Phase 0, exploratory clinical study aims at assessing the safety and potential for allergic reactions (allergenicity) of a new vaccine for cat allergy in adult, cat allergic patients. The vaccine is bio-engineered to provide high level expression of the allergenic major cat allergen but with reduced capacity to trigger allergic reactions. In this study, safety will be assessed using physical exams and adverse events reporting. Allergenicity of the new investigational vaccine will be assessed by performing Skin Prick Tests (SPT, with the superficial puncture of the forearm skin) and intradermal injections (injection in a deeper layer of the skin) of several dilutions of a vaccine stock solution. Comparable dilutions of a commercial cat dander extract will also be administered by SPT and intradermal injections, to the same subjects (but on a different forearm), for comparison purposes. Early phase skin reactions will be measured as the size of the weal induced by these products at 15 minutes post-administration, in-line with standard allergy skin testing. Because of the new vaccine technology used, it is expected that skin reactions will be less significant with the investigational product than the commercial one, at comparable dilutions. This study, to be conducted in eligible adult, male and female cat allergic patients, will allow the selection of safe doses of the vaccine for future clinical studies, where proposed dosing regimens will be tested. Only one clinical site (in London, UK) will be involved in this research project. Finally, this is a short study, where only one vaccine/commercial product dilution administration session will take place, followed by a 24 hour safety assessment period.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
22/SC/0464
Date of REC Opinion
3 Feb 2023
REC opinion
Further Information Unfavourable Opinion