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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No immunotherapy (IT) Cohort | Experimental | 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 |
|
| Subcutaneous Immunotherapy (SCIT) cohort | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intradermal cat allergen challenge | Drug | Participants will undergo intradermal cat allergen challenge in bilateral upper arms at baseline (Day 1) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total number of analyzable cells from the lymph node fine-needle aspiration | The total number of analyzable cells per Fine-Needle Aspiration (FNA) sample will be summarized descriptively (Mean and Standard Deviation, Median, Minimum, and Maximum values, and proportion of samples yielding >100,000 analyzable cells) | At Day 4 and Week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of adverse events related to lymph node sampling | Adverse Events (AEs) assessed as related to the lymph node sampling will be summarized by cohort and overall | From Baseline to Week 3 |
| Total number of adverse events related to adenoid swab |
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Inclusion Criteria:
Exclusion Criteria:
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
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
History of chronic obstructive pulmonary disease
History of recurrent acute sinusitis, defined as 2 episodes per year for the last 2 years, all of which required antibiotic treatment
History of chronic sinusitis, defined as sinus symptoms lasting greater than 12 weeks that includes 2 or more major factors or 1 major factor and 2 minor factors. Major factors are defined as facial pain or pressure, nasal obstruction or blockage, nasal discharge or purulence or discolored postnasal discharge, purulence in nasal cavity, or impaired or loss of smell. Minor factors are defined as headache, fever, halitosis, fatigue, dental pain, cough, and ear pain, pressure, or fullness
History of disease affecting the immune system such as autoimmune disease (e.g., systemic lupus erythematosus), immune complex disease (e.g., serum sickness), or immunodeficiency, which, in the opinion of the site investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or may impact the quality or interpretation of the data obtained from the study
History of malignancy of any type, excluding basal cell and squamous cell cancers of the skin that only required surgical excision or in situ carcinoma of the cervix study provided that curative therapy was completed at least 12 months prior to informed consent
Any of the following:
Pregnant, planning a pregnancy during the study, or breast-feeding
Bleeding disorders
BMI >= 40
Other anatomic or musculoskeletal abnormalities that would interfere with FNA sampling procedure
History of lymphedema
Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the site investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or may impact the quality or interpretation of the data obtained from the study
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tanya M Laidlaw, MD | Contact | 617-732-9850 | tlaidlaw@bwh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Carolyn Baloh, M.D. | Brigham and Women's Hospital: Division of Allergy and Clinical Immunology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital: Division of Allergy and Clinical Immunology | Recruiting | Boston | Massachusetts | 02215 | United States |
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| Label | URL |
|---|---|
| Division of Allergy, Immunology, and Transplantation | View source |
| National Institute of Allergy and Infectious Diseases | View source |
| Immune Tolerance Network (ITN) |
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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The summarization of adverse events (AEs) related to lymph node sampling will be repeated for the AEs assessed as related to the adenoid swab |
| From Baseline to Week 3 |