Actively Recruiting
LYmph Node eXamination in Cat Allergen Immunotherapy
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-05-01
16
Participants Needed
1
Research Sites
41 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Sixteen eligible cat-allergic participants will be accrued in the study. Eight participants who have been on subcutaneous immunotherapy (SCIT) at maintenance dosing for at least 1 year will be assigned to the SCIT cohort, and 8 participants who have never been on cat immunotherapy will be assigned to the No immunotherapy (IT) cohort. Participants will undergo intradermal cat allergen challenge in bilateral upper arms at baseline (Day 1), will undergo axillary lymph node and peripheral blood sampling at Day 4, and axillary lymph node, peripheral blood, and adenoid and nasal sampling at Week 3. The primary objective is to determine the number of analyzable cells from axillary lymph node fine-needle aspiration 3 days and 3 weeks after intradermal cat allergen challenge in two cohorts of cat-allergic participants: those undergoing cat allergen immunotherapy and those who are not receiving this treatment
CONDITIONS
Official Title
LYmph Node eXamination in Cat Allergen Immunotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and provide informed consent
- History of moderate to severe rhinoconjunctivitis symptoms caused by cat exposure interfering with daily activities or sleep
- Skin prick test wheal ≥ 5 mm to standardized cat extract or cat-specific IgE ≥ 0.7 kU/L within 5 years
- Female participants of childbearing potential must have a negative pregnancy test at screening
- For SCIT cohort: at least 1 year of maintenance subcutaneous cat allergen immunotherapy with ongoing treatments at least every 6 weeks
You will not qualify if you...
- Unable or unwilling to give informed consent or comply with study protocol
- Current household or regular occupational exposure to cats
- For No immunotherapy cohort: any previous or current allergen immunotherapy treatment
- History of grade 4 anaphylaxis
- Partially controlled or uncontrolled asthma within 4 weeks before screening
- Severe asthma or emergency visits for asthma in the past 12 months
- History of chronic obstructive pulmonary disease
- History of recurrent acute sinusitis requiring antibiotics
- History of chronic sinusitis with specified symptoms
- Immune system diseases affecting study participation
- History of malignancy except certain skin cancers or treated cervical carcinoma
- Recent tobacco, vaping, or illicit inhaled substance use
- Recent investigational product use, systemic corticosteroids, immunoglobulin, or blood products
- Use of immunosuppressants or biologics targeting immune system within specified timeframes
- Recent vaccination within 6 weeks
- Pregnant, planning pregnancy, or breastfeeding
- Bleeding disorders
- BMI ≥ 40
- Anatomic or musculoskeletal issues interfering with sampling
- History of lymphedema
- Other medical problems posing risks or affecting study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital: Division of Allergy and Clinical Immunology
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
T
Tanya M Laidlaw, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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