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Study in Allergic Adults to Support the Development of Immunological Assays

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01320137
First received: March 21, 2011
Last updated: December 6, 2016
Last verified: September 2011
  Purpose
The purpose of this study is to develop and characterize immunological assays on blood samples.

Condition Intervention
Immunologic Tests
Procedure: Blood withdrawal

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Study in Adult Subjects With Allergy to Support the Development of Immunological Assays

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Number of Subject Responders With Antigen-Th2 CD4+ T Cells Expressing Interferon-gamma (IFN-γ) [ Time Frame: At Day 0 ]
    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

  • Number of Subject Responders With Antigen-Th2 CD4+ T Cells Expressing IFN-γ - Amended Definition [ Time Frame: At Day 0 ]
    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.


Enrollment: 80
Study Start Date: March 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group A
Birch-allergic subjects
Procedure: Blood withdrawal
Blood sampling
Group B
Healthy subjects
Procedure: Blood withdrawal
Blood sampling

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

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01320137

Locations
Belgium
GSK Investigational Site
Gent, Belgium, 9000
GSK Investigational Site
La Louvière, Belgium, 7100
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01320137     History of Changes
Other Study ID Numbers: 115315
Study First Received: March 21, 2011
Results First Received: December 6, 2016
Last Updated: December 6, 2016

Keywords provided by GlaxoSmithKline:
Immunological assay
Birch allergy

ClinicalTrials.gov processed this record on May 25, 2017