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Characterization of Immune Response to Intradermal Influenza Vaccination
The goal of this study is to characterize the immune response, both innate and adaptive, as well as locally and systemic, to intradermal (ID) vaccination in healthy individuals. The intervention involves intradermal administration of an FDA-approved intramuscular seasonal influenza vaccine, using an FDA-approved device MicronJet. Investigators will measure antibody titers, cell subtypes, and multi-omic profiles, by collecting skin and peripheral blood at baseline and at several time points after vaccination. The primary objective is to identify baseline correlates of immune response in the skin and peripheral blood to the seasonal influenza vaccine. The investigators secondary goals are to describe the inflammatory response in the skin over time.
Details
| Lead sponsor | Yale University |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | RECRUITING |
| Enrolment | 249 |
| Start date | 2024-01-24 |
| Completion | 2026-05 |
Conditions
- Vaccine Reaction
Interventions
- MicronJet
- Fluzone® Quadrivalent
- Fluzone® Quadrivalent
- Bacteriostatic Saline
Primary outcomes
- Change in antibody titer concentration to vaccination-Blood — Day 0 and Day 28
Change in antibody titer to vaccination as measured by microneutralization titers at day 0 and day 28 will be correlated with biomarkers in the blood using generalized estimating equations. - Change in antibody titer concentration to vaccination-Skin — Day 0 and Day 28
Change in antibody titer to vaccination as measured by microneutralization titers at day 0 and day 28 will be correlated with biomarkers in the skin at baseline using generalized estimating equations.
Countries
United States