Clinical trial NCT06067555: Intradermal Influenza Vaccination
Official title: Characterization of Immune Response to Intradermal Influenza Vaccination
Conditions: Vaccine Reaction
Summary: 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.
Interventions:
description: MicronJet 600 syringe will be used to administer intradermal flu vaccine injections
name: MicronJet
type: Device
description: Intradermal injections of 0.3mL
name: Fluzone® Quadrivalent
type: Biological
description: Intramuscular injection of 0.3mL
name: Fluzone® Quadrivalent
type: Biological
description: Intradermal injection of 0.3mL (control)
name: Bacteriostatic Saline
type: Other
Study arms:
design_group_description: An intramuscular control group, from which no skin biopsies will be taken after vaccination. Only the intramuscular cohort will receive the flu vaccine via standard IM route in the deltoid region of the upper arm.
design_group_title: Intramuscular (IM) Control
design_group_type: Active Comparator
design_group_description: Participants receive intradermal flu vaccination in the upper arm and will have skin biopsy of vaccination site 2 hours after vaccine administration.
design_group_title: ID-2hour
design_group_type: Experimental
design_group_description: Participants receive intradermal flu vaccination in the upper arm and will have skin biopsy of vaccination site 6 hours after vaccine administration.
design_group_title: ID-6hour
design_group_type: Experimental
design_group_description: Participants receive intradermal flu vaccination in the upper arm and will have skin biopsy of vaccination site 1 day after vaccine administration.
design_group_title: ID-1day
design_group_type: Experimental
design_group_description: Participants receive intradermal flu vaccination in the upper arm and will have skin biopsy of vaccination site 3 days after vaccine administration.
design_group_title: ID-3day
design_group_type: Experimental
design_group_description: Participants receive intradermal flu vaccination in the upper arm and will have skin biopsy of vaccination site 3 days after vaccine administration.
design_group_title: ID-28day
design_group_type: Experimental
design_group_description: A control group in which bacteriostatic saline is injected intradermally in lieu of influenza vaccine. A skin biopsy will be taken from the "vaccination" site 2 hours after administration.
design_group_title: Sal-2hour
design_group_type: Placebo Comparator
design_group_description: A control group in which bacteriostatic saline is injected intradermally in lieu of influenza vaccine. A skin biopsy will be taken from the "vaccination" site 6 hours after administration.
design_group_title: Sal-6hour
design_group_type: Placebo Comparator
design_group_description: A control group in which bacteriostatic saline is injected intradermally in lieu of influenza vaccine. A skin biopsy will be taken from the "vaccination" site 1 day after administration.
design_group_title: Sal-1hour
design_group_type: Placebo Comparator
Sponsor: Yale University
Collaborators: The University of Chicago
Silicon Valley Community Foundation
Drug name mappings:
name: 四价流感病毒裂解疫苗(Sanofi)
lang: CN
name: Tetravalent influenza vaccine(Split, inactivated)(Sanofi)
lang: EN