Influenza
Conditions
Brief summary
Cellular: Antigen activated CD4+ T-lymphocytes measured at –14, day +7 day +28 [+/-5 days]and day +90 [+/-5 days] after vaccination., Humoral: Number of participants with ≥-4-fold rise in mucosal antibody titer against each vaccine virus haemagglutinin antigens vaccine-specific antibody (IgG and IgA) titers in respiratory secretions measured using antibody titer measured at –14, day +7 day +28 [+/-5 days]and day +90 [+/-5 days] after vaccination
Detailed description
Cellular: Quantification and characterization of leukocyte cell subsets, incl T- and B-cell subsets and activation patterns, using highly standardized flowcytometry in combination with single cell RNAsequencing (scRNAseq) analysis coupled with single cell surface marker profiling (CITEseq or similar platform) for in-depth characterization of immune cell subsets measured at –14, day +7 day +28 [+/-5 days]and day +90 [+/-5 days] after vaccination, Humoral: Number of participants with ≥-4-fold rise in serum antibody titers against each vaccine virus haemagglutinin antigens vaccine-specific antibody (IgG) titers in serum measured using antibody titer measured measured at –14, day +7 day +28 [+/-5 days]and day +90 [+/-5 days] after vaccination.
Interventions
DRUGVaxigrip suspension for injection in pre-filled syringe.
Trivalent influenza vaccine (split virion
DRUGinactivated).
DRUGnasal)
DRUGFluenz Placebo
DRUG-
Sponsors
Gentofte Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cellular: Antigen activated CD4+ T-lymphocytes measured at –14, day +7 day +28 [+/-5 days]and day +90 [+/-5 days] after vaccination., Humoral: Number of participants with ≥-4-fold rise in mucosal antibody titer against each vaccine virus haemagglutinin antigens vaccine-specific antibody (IgG and IgA) titers in respiratory secretions measured using antibody titer measured at –14, day +7 day +28 [+/-5 days]and day +90 [+/-5 days] after vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Cellular: Quantification and characterization of leukocyte cell subsets, incl T- and B-cell subsets and activation patterns, using highly standardized flowcytometry in combination with single cell RNAsequencing (scRNAseq) analysis coupled with single cell surface marker profiling (CITEseq or similar platform) for in-depth characterization of immune cell subsets measured at –14, day +7 day +28 [+/-5 days]and day +90 [+/-5 days] after vaccination, Humoral: Number of participants with ≥-4-fold rise in serum antibody titers against each vaccine virus haemagglutinin antigens vaccine-specific antibody (IgG) titers in serum measured using antibody titer measured measured at –14, day +7 day +28 [+/-5 days]and day +90 [+/-5 days] after vaccination. | — |
Countries
Denmark
Outcome results
None listed