LYmph Node eXamination in Cat Allergen Immunotherapy
United States16 participantsStarted 2026-04-10
Plain-language summary
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
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. Participant must be able to understand and provide informed consent
✓. A clinical history of moderate to severe rhinoconjunctivitis symptoms caused by cat exposure, such that exposure is currently, or was historically to the initiation of treatment, interfering with usual daily activities or with sleep, as defined according to the ARIA classification of rhinitis
✓. Skin prick test wheal greater than or equal to 5 mm to standardized cat extract or cat-specific IgE greater than or equal to 0.7 kU/L obtained within 5 years of screening. These can be obtained from medical records if available from the prior 5 years, or at the screening visit if not
✓. Female participants of childbearing potential must have a negative pregnancy test at the screening visit prior to performing study procedures
✓. For participants in the Subcutaneous Immunotherapy (SCIT) cohort, the following inclusion criterion applies as well: A history of at least 1 year of maintenance subcutaneous allergen immunotherapy to cat, with currently ongoing immunotherapy treatments at least every 6 weeks
Exclusion criteria
✕. Inability or unwillingness of a participant to give written informed consent or comply with study protocol
What they're measuring
1
Total number of analyzable cells from the lymph node fine-needle aspiration
Timeframe: At Day 4 and Week 3
Trial details
NCT IDNCT07447869
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
✕. Current household exposure to cat or regular occupational exposure to cat
✕. For participants in No immunotherapy (IT) cohort, any previous immunotherapy treatment with cat allergen
✕. For participants in No IT cohort, any current treatment with any form of allergen immunotherapy
✕. A history of grade 4 anaphylaxis due to any cause as defined by the WAO grading criteria
✕. Partially controlled or uncontrolled asthma as per Global Initiative for Asthma (GINA) guidelines in the 4 weeks prior to screening. Participants may be rescreened once asthma is well-controlled
✕. Severe asthma as defined by GINA guidelines in the previous 12 months
✕. History of emergency visit or hospital admission for asthma in the previous 12 months