Study in Allergic Adults to Support the Development of Immunological Assays

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

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

Study Overview

• Status: Completed
• Conditions: Immunologic Tests
• Intervention / Treatment: Procedure: Blood withdrawal

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium, 9000
    • GSK Investigational Site
  • La Louvière, Belgium, 7100
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2011
• Primary Completion (Actual): May 11, 2011
• Study Completion (Actual): May 11, 2011

Study Registration Dates

• First Submitted: March 21, 2011
• First Submitted That Met QC Criteria: March 21, 2011
• First Posted (Estimate): March 22, 2011

Study Record Updates

• Last Update Posted (Actual): June 20, 2017
• Last Update Submitted That Met QC Criteria: May 24, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Immunological assay; Birch allergy
• Other Study ID Numbers: 115315