The present study aims to assess the natural immunity to specific microbial antigens in healthy subjects and in subjects with stable COPD aged between 45-75 years.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
73
Blood collection at Day 0 (all subjects) and at Month 6 (COPD subjects) for the analysis of serology, cell-mediated immune response.
Nasopharyngeal and oropharyngeal swabs collection at Day 0 (All subjects) and at exacerbation visits (COPD subjects).
Sputum collection at Day 0 and at exacerbation visits (COPD subjects)
GSK Investigational Site
Brussels, Belgium
GSK Investigational Site
Ghent, Belgium
GSK Investigational Site
Liège, Belgium
Anti-protein D Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per millilitre (EU/mL)
Time frame: At Day 0
Anti-protein D Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)
Time frame: At Month 6
Anti-Pneumococcal Histidine Triad D Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)
Time frame: At Day 0
Anti-Pneumococcal Histidine Triad D Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)
Time frame: At Month 6
Anti-pneumolysin Antibody Concentrations
The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.
Time frame: At Day 0
Anti-pneumolysin Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)
Time frame: At Month 6
Concentrations for Serum Protein-D Enzymatic Inhibition
Concentrations are presented as geometric mean concentrations (GMCs). The reference seropositivity cut-off value was ≥ 17.8%.
Time frame: At Day 0
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Concentrations for Serum Protein-D Enzymatic Inhibition
Concentrations are presented as geometric mean concentrations (GMCs). The reference seropositivity cut-off value was ≥ 17.8%.
Time frame: At Month 6
Number of Subjects With PD Enzymatic Inhibition Concentration Greater Than or Equal to (≥) 17.8%
Concentrations were expressed as geometric mean concentrations (GMCs)
Time frame: At Day 0
Number of Subjects With PD Enzymatic Inhibition Concentration Greater Than or Equal to (≥) 17.8%
Concentrations were expressed as geometric mean concentrations (GMCs)
Time frame: At Month 6
Frequency of Specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α), Interferon-γ (IFN-γ), IL-13 and IL-17 Upon in Vitro Stimulation
Time frame: At Day 0
Frequency of Specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α), Interferon-γ (IFN-γ), IL-13 and IL-17 Upon in Vitro Stimulation
Time frame: At Day 0
Number of Subjects With Positive Sputum - Culture Testing Results
Time frame: At Day 0
Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results
Time frame: At Day 0
Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results
Time frame: At Day 0