Clinical trial NCT01320137: Study in Allergic Adults to Support the Development of Immunological Assays
Official title: A Study in Adult Subjects With Allergy to Support the Development of Immunological Assays
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunologic Tests
Keywords: Immunological assay
Birch allergy
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-03-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Number of Subject Responders With Antigen Specific Lymphocytes T Helper 2 (Th2) Cluster of Differentiation 4+ (CD4+) T Cells Expressing Cytokines
timeFrame: At Day 0
measure: Number of Subject Responders With Antigen Specific Th2 CD4+ T Cells Expressing Cytokines - Amended Definition
timeFrame: At Day 0
Secondary outcomes:
measure: Number of Subject Responders With Antigen-Th2 CD4+ T Cells Expressing Interferon-gamma (IFN-γ)
timeFrame: At Day 0
measure: Number of Subject Responders With Antigen-Th2 CD4+ T Cells Expressing IFN-γ - Amended Definition
timeFrame: At Day 0
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: GSK Investigational Site
city: La Louvière
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: