Healthy volunteers (influenza vaccination)
Conditions
Interventions
Trade Name: EFLUELDA
Pharmaceutical Form: Suspension for injection in pre-filled syringe
Pharmaceutical Form: Suspension for injection in pre-filled syringe
Sponsors
Centre Hospitalier Annecy Genevois
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 65 years or older, the day of inclusion; 2. Have signed and dated Informed Consent Form; 3. Able and willing to attend all scheduled visits, and to comply with study procedures; 4. Covered by French health insurance. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: Non-inclusion: 1. Any vaccine injection (including COVID-19 vaccine) in the 4 weeks preceding study inclusion; 2. Plan to receive any vaccine (including COVID-19 vaccine) in the 4 weeks following study inclusion; 3. Already vaccinated against influenza for 2021-2022 season; 4. Hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances; 5. HIV infection; 6. Active Hepatitis B, or active Hepatitis C; 7. Previous Guillain Barré syndrome; 8. Ongoing immunosuppressive treatment or active immunodeficiency; 9. Receipt of immune globulins, blood or blood-derived products in the past 3 months; 10. Thrombocytopenia or bleeding disorder, receipt of anticoagulants contraindicating IM vaccination based on investigator’s judgment; 11. Influenza-like illness symptoms, including COVID-19, within 4 weeks before study inclusion; 12. Patients subject to legal protection measures. Exclusion: 1. Any subject presenting with influenza-like illness symptoms, including COVID-19 between inclusion (visit 1) and randomization (visit 2); 2. Subject unable to attempt visit at Day 0 (visit 2) and Day 1 (visit 3); 3. Blood sample at Day 0 (visit 2) impossible to obtain; 4. Receipt of vaccine injection or equivalent between inclusion (visit 1) and randomization (visit 2), other than those allowed and planned in the study. This includes non-study dose of 2021–2022 influenza vaccine, blood-derived immune globulins, blood, or blood-derived products. 5. Any unexpected event relevant to the physician in charge, after discussion with the coordinating investigator and the sponsor These subjects will not be randomized and not followed after the second visit. Study team will propose influenza vaccination outside of the study, as per standard of care.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of QIV-HD and QIV-SD vaccines in subjects 65 years of age and older on: -the early systemic innate immune response through transcriptomic analysis i.e. innate gene signature including interferon signaling pathways, -innate cells including antigen presenting and inflammatory cells, -gene signature associate with adaptive immune response before and after the influenza vaccination, -humoral immunity i.e. HI titers, at different time points. ;Secondary Objective: Not applicable;Primary end point(s): Outcomes will be measure in each subject. Measures will be reported by allocated arm: QIV-HD arm or QIV-SD arm. Transcriptomic Transcriptomic profiles of blood cells (microarrays) will be performed to measure early systemic innate immune response. Samples will be collected seven days prior vaccine injection (D-7, first baseline), the day of vaccine injection (D0, second baseline) to assess the stability of biomarkers, and one day after vaccine injection (D+1). Innate cellular phenotyping Innate cellular phenotyping will be performed using 36 surface markers deciphering lineage cells monocytes, neutrophils, NK, antigen-presenting cells. The technology used is based on Aurora spectral cytometry (Cyteck). These data will be integrated in final innate gene signature analysis. Gene signature The innate immune response will be assessed at D+1 after vaccination. We will compare gene expression with the basal gene expression status at baseline (D-7 and D0), by studying the transcriptional profile of the blood cells by microarrays. Humoral immune responses We will measure and report the evolution of: •HAI titers obtained on D0, D21, D90 and D210 •Individual HAI titers ratio D21/D0, D90/D0 and D210/D0 •Subjects with titers = 40 at D21, D90 and D210 •Seroconversion: titer < 10 at D0 and post-vaccination titer = 40 at D21, D90 and D210 or titer = 10 at D0 and a = 4-fold increase in titer at D21, D90 and D210) Humoral response results will | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
France
Contacts
Public ContactDRCI - Marion GHIDI
Centre Hospitalier Annecy Genevois
Outcome results
None listed