LYmph Node eXamination in Cat Allergen Immunotherapy
ConditionAllergy
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
Inability or unwillingness of a participant to give written informed consent or comply with study protocol
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
Trial design
Treatments tested in this trial
- Intradermal cat allergen challenge
Treatment groups
16 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov