LYmph Node eXamination in Cat Allergen Immunotherapy

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT07447869
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Allergy

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Intradermal cat allergen challenge — DRUG
    Participants will undergo intradermal cat allergen challenge in bilateral upper arms at baseline (Day 1)

Study Details

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

Key Dates

Start date
Apr 10, 2026
Status verified
Apr 2026
Primary completion
Jan 27, 2027
Completion
Jan 27, 2027

Study Design

Enrollment
16 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: No immunotherapy (IT) Cohort
    Participants who have never been on cat immunotherapy will be assigned to this 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. Lymph node sampling will occur in one axilla at Day 4 and in the contralateral axilla at Week 3
  • Experimental: Subcutaneous Immunotherapy (SCIT) cohort
    Participants who have been on Subcutaneous Immunotherapy (SCIT) at maintenance dosing for at least 1 year will be assigned to this 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. Lymph node sampling will occur in one axilla at Day 4 and in the contralateral axilla at Week 3

Primary Outcome Measure

Total number of analyzable cells from the lymph node fine-needle aspiration [ Time Frame: At Day 4 and Week 3 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's Hospital: Division of Allergy and Clinical ImmunologyBostonMassachusetts02215-

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Brigham and Women's Hospital: Division of Allergy and Clinical Immunology· Boston, MA

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