Immunologic Tests
Conditions
Keywords
Immunological assay, Birch allergy
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.
Interventions
PROCEDUREBlood withdrawal
Blood sampling
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subject Responders With Antigen Specific Lymphocytes T Helper 2 (Th2) Cluster of Differentiation 4+ (CD4+) T Cells Expressing Cytokines | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Subject Responders With Antigen-Th2 CD4+ T Cells Expressing Interferon-gamma (IFN-γ) | 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 | 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. |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Allergy Group Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen. | 40 |
| Control Group Subjects with ages ranging from 18-45 years and inclusive, with no known allergies. | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | Allergy Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 30.1 Years STANDARD_DEVIATION 7.44 | 28.6 Years STANDARD_DEVIATION 6.92 | 29.35 Years STANDARD_DEVIATION 7.18 |
| Sex: Female, Male Female | 26 Participants | 19 Participants | 45 Participants |
| Sex: Female, Male Male | 14 Participants | 21 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
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
Time frame: At Day 0
Population: The According-To-Protocol (ATP) cohort, Bet v 1 BrdU+ subjects included all subjects from the ATP cohort for which proliferation of peripheral blood mononuclear cells (PBMCs) with the birch pollen allergen Bet v 1 was observed after 96 hours.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Allergy Group | Number of Subject Responders With Antigen Specific Lymphocytes T Helper 2 (Th2) Cluster of Differentiation 4+ (CD4+) T Cells Expressing Cytokines | IL-13 | 7 Subjects |
| Allergy Group | Number of Subject Responders With Antigen Specific Lymphocytes T Helper 2 (Th2) Cluster of Differentiation 4+ (CD4+) T Cells Expressing Cytokines | IL-5 | 7 Subjects |
| Control Group | Number of Subject Responders With Antigen Specific Lymphocytes T Helper 2 (Th2) Cluster of Differentiation 4+ (CD4+) T Cells Expressing Cytokines | IL-13 | 1 Subjects |
| Control Group | Number of Subject Responders With Antigen Specific Lymphocytes T Helper 2 (Th2) Cluster of Differentiation 4+ (CD4+) T Cells Expressing Cytokines | IL-5 | 0 Subjects |
Primary
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.
Time frame: At Day 0
Population: The According-To-Protocol (ATP) cohort, Bet v 1 BrdU+ subjects included all subjects from the ATP cohort for which proliferation of peripheral blood mononuclear cells (PBMCs) with the birch pollen allergen Bet v 1 was observed after 96 hours.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Allergy Group | Number of Subject Responders With Antigen Specific Th2 CD4+ T Cells Expressing Cytokines - Amended Definition | IL-13 | 6 Subjects |
| Allergy Group | Number of Subject Responders With Antigen Specific Th2 CD4+ T Cells Expressing Cytokines - Amended Definition | IL-5 | 7 Subjects |
| Control Group | Number of Subject Responders With Antigen Specific Th2 CD4+ T Cells Expressing Cytokines - Amended Definition | IL-13 | 0 Subjects |
| Control Group | Number of Subject Responders With Antigen Specific Th2 CD4+ T Cells Expressing Cytokines - Amended Definition | IL-5 | 1 Subjects |
Secondary
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.
Time frame: At Day 0
Population: The According-To-Protocol (ATP) cohort, Bet v 1 BrdU+ subjects included all subjects from the ATP cohort for which proliferation of peripheral blood mononuclear cells (PBMCs) with the birch pollen allergen Bet v 1 was observed after 96 hours.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Allergy Group | Number of Subject Responders With Antigen-Th2 CD4+ T Cells Expressing IFN-γ - Amended Definition | 8 Subjects |
| Control Group | Number of Subject Responders With Antigen-Th2 CD4+ T Cells Expressing IFN-γ - Amended Definition | 2 Subjects |
Secondary
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
Time frame: At Day 0
Population: The According-To-Protocol (ATP) cohort, Bet v 1 BrdU+ subjects included all subjects from the ATP cohort for which proliferation of peripheral blood mononuclear cells (PBMCs) with the birch pollen allergen Bet v 1 was observed after 96 hours.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Allergy Group | Number of Subject Responders With Antigen-Th2 CD4+ T Cells Expressing Interferon-gamma (IFN-γ) | 8 Subjects |
| Control Group | Number of Subject Responders With Antigen-Th2 CD4+ T Cells Expressing Interferon-gamma (IFN-γ) | 3 Subjects |