Allergy to cats, inducing rhino-conjunctivitis with or without asthma Other
Conditions
Interventions
This study will compare the safety and allergenicity of two Fel d 1 allergen sources: Angany new vaccine vs the commercially available ALK Soluprick cat dander extract. All 20 study participants will
the vaccine diluent and a histamine solution will also be used as controls. On the internal surface of the other forearm: 5 ALK Soluprick dilutions (from 1/100,000 to 1/10) as well as the undiluted so
the vaccine diluent and a histamine solution will also be used as controls. Subjects will be randomized according to the dominant vs non-dominant arm receiving the vaccine using a simple randomization
for IDTs, an adequate between-tests and between-subjects lag time will be used to assess safety. All SPTs and IDTs will be performed on the same day. Patients will be seen again 6.5 hours after the fi
Sponsors
Angany Innovation SAS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults (male or female) aged 18-60 years 2. Documented recent (2 years) history of cat-induced: 2.1. Moderate to severe persistent allergic rhinitis or rhinoconjunctivitis with or without: 2.2. Allergic asthma (Global Initiative for Asthma [GINA] =Step 3) 3. A valid positive SPT (mean wheal diameter =7 mm obtained after screening, duplicate cat dander extract SPT) for cat 4. Cat-specific serum immunoglobulin E (IgE) measured by ImmunoCAP (=1 kUA/L) 5. Fel d 1 specific serum IgE measured by ImmunoCAP (=1 kUA/L) 6. Female subjects must be: 6.1. Of non-child-bearing potential (surgically sterilized or post-menopausal [12 months with no menses without alternative medical cause]) OR 6.2. Not pregnant, non-breastfeeding or planning to become pregnant AND willing to comply with the highly effective or effective contraceptive requirements of the study from Screening to at least 28 days after the last Investigational Medicinal Product (IMP) administration. Highly effective and effective contraceptive methods include: combined hormonal contraceptives (pills, patch or vaginal ring), copper intrauterine device, tubal ligation, progestogen implant, levonorgestrel intra-uterine releasing system and depot medroxyprogesterone acetate subcutaneous (SC) or intramuscular (IM) injections. 7. Able to speak, read and understand English sufficiently to understand the purposes and risks of the study and to provide written informed consent 8. Willing, able and available to comply with all study procedures
Exclusion criteria
Exclusion criteria: 1. History of current clinically significant gastrointestinal, hepatic, renal, cardiovascular, endocrine, oncological, immunological, neurological, ophthalmological, haematological, respiratory or psychiatric disorder or any other condition, which in the opinion of the investigator or sponsor would jeopardize the safety of the subject or the validity of the study results 2. Severe or uncontrolled asthma as assessed by the GINA Asthma symptom control questionnaire OR current treatment for asthma at GINA > Step 3 OR screening FEV1 less than 80% predicted 3. Subjects with a medical history of frequent or repeated severe or life-threatening episodes of anaphylaxis or anaphylactic shock. 4. Subjects with skin disorders that would hinder skin testing and/or its interpretation (e.g., severe generalized active atopic dermatitis) 5. Large tattoo(s) on the forearm, which could prevent the adequate assessment of wheal size, according to the investigator 6. Any medical condition in which adrenaline (epinephrine) is contraindicated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety assessed with vital signs (blood pressure, heart rate, respiratory rate, body temperature and oxygen saturation) , physical exams, FEV-1 assessment (for sentinel subjects only) and adverse events reporting at visit day 1, pre- and post-study imp administration, and during the 24-hour post-imp administration safety follow-up period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Skin reactivity/allergenicity: 1.1. The early phase skin response (wheal diameter) to Fel d 1-BP in a titrated SPT and IDT compared to a commercial cat dander allergen extract, will be evaluated 15 min after vaccine IMP or commercial cat dander extract. The primary efficacy outcome will be the provocation concentration of allergen that causes a =5 mm skin wheal. Following SPTs and IDTs, the wheal will be outlined with a washable ink pen. the outline will then be lifted using adhesive tape applied to the skin and then transferred onto a paper recording sheet. The mean diameter of the wheal will be calculated. 1.2. The late-phase skin response following intradermal administration of Fel d 1-BP will be compared to the commercial extract at 6.5 hours after the first intradermal administration. The extent of the late-phase response will be measured using a pencil friction technique. 1.3 The provocation concentration of allergen that causes a =3 mm skin wheal post-SPT and post-IDT will also be determined as an additional secondary endpoint. | — |
Countries
England, United Kingdom
Contacts
Public ContactPatrick Colin
Outcome results
None listed