A Study in Adult Subjects With Allergy to Support the Development of Immunological Assays
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Number of Subject Responders With Antigen Specific Lymphocytes T Helper 2 (Th2) Cluster of Differentiation 4+ (CD4+) T Cells Expressing Cytokines
Study Overview
Brief Summary
The purpose of this study is to develop and characterize immunological assays on blood samples.
Detailed Description
This is a clinical study in which there is no vaccine administered. It is designed for research purposes such as developing immunological assays.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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).
Arms & Interventions
Allergy Group
Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.
Intervention: Blood withdrawal (Procedure)
Control Group
Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
Intervention: Blood withdrawal (Procedure)
Outcomes
Primary Outcomes
Number of Subject Responders With Antigen Specific Lymphocytes T Helper 2 (Th2) Cluster of Differentiation 4+ (CD4+) T Cells Expressing Cytokines
Time Frame: At Day 0
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
Number of Subject Responders With Antigen Specific Th2 CD4+ T Cells Expressing Cytokines - Amended Definition
Time Frame: At Day 0
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.
Secondary Outcomes
- Number of Subject Responders With Antigen-Th2 CD4+ T Cells Expressing Interferon-gamma (IFN-γ)(At Day 0)
- Number of Subject Responders With Antigen-Th2 CD4+ T Cells Expressing IFN-γ - Amended Definition(At Day 0)