Study in Allergic Adults to Support the Development of Immunological Assays

Study Overview
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Brief Summary
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The purpose of this study is to develop and characterize immunological assays on blood samples.

Detailed Description
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This is a clinical study in which there is no vaccine administered. It is designed for research purposes such as developing immunological assays.

Official Title
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A Study in Adult Subjects With Allergy to Support the Development of Immunological Assays

Conditions
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Immunologic Tests

Intervention / Treatment
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* Procedure: Blood withdrawal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who the investigator believes can and will comply with the requirements of the protocol. Written informed consent obtained from the subject. Healthy subjects (except the condition studied in the ALLERGY group). A male or female between, and including 18 and 45 years of age at the time of study start. Subject presenting moderate to severe clinical symptoms of allergy within the week before enrolment (only for ALLERGY group). Subjects suffering from seasonal allergy to birch pollen previously documented by a medical history (only for ALLERGY group). A positive skin prick test response realised and/or a positive test for specific IgE against birch within the last 5 years (only for ALLERGY group). Exclusion Criteria: Any known or clinical signs of anaemia or any condition that would preclude the drawing of blood as described in the protocol. Receipt of blood products 120 days prior to study visit. Receipt of immunoglobulin 120 days prior to study visit. Use of any investigational or non-registered product within 30 days preceding the study visit. Concurrently participating in another clinical study, at the time of the study visit, in which the subject has been or will be exposed to an investigational or a non-investigational product. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history. Any confirmed or suspected autoimmune or inflammatory disorders. Administration of systemic or inhaled anti-inflammatory medications and, in particular, inhaled corticoid-steroids and cromoglycates within 30 days preceding the study visit. Purely local medications such as intranasal steroids or systemic symptomatic medications such as antihistamines and beta agonists are allowed. Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the study visit. Pregnant or lactating female. Any past or current birch-specific immunotherapy (only for ALLERGY group). Any allergic disease as established by medical history before study start (only for CONTROL group). Family history of allergic diseases in the first degree family members (only for CONTROL group).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Allergy Group<br>Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen. | Procedure: Blood withdrawal<br>* Blood sampling<br>|
| Other: Control Group<br>Subjects with ages ranging from 18-45 years and inclusive, with no known allergies. | Procedure: Blood withdrawal<br>* Blood sampling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subject Responders With Antigen Specific Lymphocytes T Helper 2 (Th2) Cluster of Differentiation 4+ (CD4+) T Cells Expressing Cytokines | Among cytokines expressed were interleukin-4 (IL-4), interleukin-5 (IL-5) and/or interleukin-13 (IL-13), as measured by flow cytometry and multiplex assays. Responders were defined as subjects with a concentration after Bet v 1 stimulation above Percentile 95 (P95) (determined on Betula verucossa 1[Bet v 1] Bromodeoxyuridine + [BrdU+] subjects) of all concentrations after medium only stimulation | At Day 0 | 
| Number of Subject Responders With Antigen Specific Th2 CD4+ T Cells Expressing Cytokines - Amended Definition | Among cytokines expressed were IL-4, IL-5 and/or IL-13, as measured by flow cytometry and multiplex assays. Responders to a specific cytokine were defined as subjects with concentration for that respective cytokine after Bet v 1 stimulation above P95 of the concentration for that cytokine after medium only stimulation for all subjects (Total cohort), AND at least 5 times higher than their own respective concentration after medium only stimulation. | At Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subject Responders With Antigen-Th2 CD4+ T Cells Expressing Interferon-gamma (IFN-γ) | Responders are defined as subjects with a concentration after Bet v 1 stimulation above P95 (determined on Bet v 1 BrdU+ subjects) of all concentrations after medium only stimulation | At Day 0 | 
| Number of Subject Responders With Antigen-Th2 CD4+ T Cells Expressing IFN-γ - Amended Definition | Responders to a specific cytokine were defined as subjects with concentration for that respective cytokine after Bet v 1 stimulation above P95 of the concentration for that cytokine after medium only stimulation for all subjects (Total cohort), AND at least 5 times higher than their own respective concentration after medium only stimulation. | At Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunological assay, Birch allergy