Study in Allergic Adults to Support the Development of Immunological Assays

NCT01320137 | Completed Results

• 1 other identifier: 115315
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Immunologic Tests

Keywords

Immunological assay; Birch allergy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (2)

Allergy Group

OTHER

Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.

Procedure: Blood withdrawal

Control Group

OTHER

Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.

Procedure: Blood withdrawal

Interventions

Blood withdrawal PROCEDURE

Blood sampling

Allergy Group; Control Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Ghent, 9000, Belgium

Location

GSK Investigational Site

La Louvière, 7100, Belgium

Location

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2011
• First Posted: March 22, 2011
• Study Start: March 31, 2011
• Primary Completion: May 11, 2011
• Study Completion: May 11, 2011
• Last Updated: June 20, 2017
• Results First Posted: January 31, 2017

Record last verified: 2017-05

Locations

BE (2)