The purpose of the study is to evaluate innate and adaptive immunity following QIV-HD vaccination compared to QIV-SD vaccination in people 65 years of age and older.
The hypothesis is that higher dose of antigen can increase the intensity and the quality of innate immunity, as the adaptive humoral and cellular responses. In this study, the objectif is to evaluate innate and adaptive immunity following QIV-HD vaccination compared to QIV-SD vaccination in people 65 years of age and older. Modifications of early blood molecular (transcriptome) and cellular (blood phenotyping) signatures within the first 24 hours following vaccination will be investigated. The association between early gene signature and late influenza-specific humoral immune responses weeks/months after vaccination will be also assessed. This study is a hase IV, randomized, open-label, active-controlled, multi-center study comparing the immune response induced by QIV-HD vaccine (intervention) and QIV-SD vaccine (control).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
60
Patient will received one dose of High Dose Quadrivalent Influenza Vaccine according to marketing authorization.
Patient will received one dose of Standard Dose Quadrivalent Influenza Vaccine according to marketing authorization.
Centre Hospitalier Annecy Genevois
Annecy, France
Centre Hospitalier Métropole Savoie
Chambéry, France
Change of Transcriptomic profiles
Transcriptomic profiles of blood cells (microarrays) will be performed to measure early systemic innate immune response
Time frame: Change from Baseline Transcriptomic profiles at day after vaccine injection (Day 1)
Change of Innate cellular phenotyping
Innate cellular phenotyping will be performed using 36 surface markers deciphering lineage cells monocytes, neutrophils, NK, antigen-presenting cells.
Time frame: Change from Baseline Innate cellular phenotyping at day after vaccine injection (Day 1)
Change of Gene signature
Study of the transcriptional profile of the blood cells by microarrays
Time frame: Change from Baseline Gene signature at day after vaccine injection (Day 1)
Humoral immune responses
HAI titers, Individual HAI titers ratio, Subjects with titers ≥ 40, Seroconversion
Time frame: Day 0, Day 21, Day 90 and Day 210 time
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