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The purpose of this study is to develop and characterize immunological assays on blood samples.
This is a clinical study in which there is no vaccine administered. It is designed for research purposes such as developing immunological assays.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allergy Group | Other | Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen. |
|
| Control Group | Other | Subjects with ages ranging from 18-45 years and inclusive, with no known allergies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood withdrawal | Procedure | Blood sampling |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Ghent | 9000 | Belgium | |||
| GSK Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Allergy Group | Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen. |
| FG001 | Control Group | Subjects with ages ranging from 18-45 years and inclusive, with no known allergies. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Allergy Group | Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen. |
| BG001 | Control Group | Subjects with ages ranging from 18-45 years and inclusive, with no known allergies. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | Number | Subjects | At Day 0 |
|
SAEs related to study participation/concurrent GSK medication/vaccine reporting was done at Day 0
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Allergy Group | Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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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 |
| La Louvière |
| 7100 |
| Belgium |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Control Group | Subjects with ages ranging from 18-45 years and inclusive, with no known allergies. |
|
|
| 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. | 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. | Posted | Number | Subjects | At Day 0 |
|
|
|
| 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 | 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. | Posted | Number | Subjects | At Day 0 |
|
|
|
| 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. | 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. | Posted | Number | Subjects | At Day 0 |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Control Group | Subjects with ages ranging from 18-45 years and inclusive, with no known allergies. | 0 | 40 | 0 | 40 |
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.