Characterization of Immune Response to Intradermal Influenza Vaccination
Overview
- Phase
- Early Phase 1
- Intervention
- Fluzone® Quadrivalent
- Conditions
- Vaccine Reaction
- Sponsor
- Yale University
- Enrollment
- 249
- Locations
- 1
- Primary Endpoint
- Change in antibody titer concentration to vaccination-Blood
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
Brief 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.
Detailed Description
Subjects will remain on study and may optionally repeat study visits (including vaccination) annually through the 2025-26 influenza season, with final study follow-up up to 1 year after vaccination. Sampling individual subjects across several influenza seasons will allow for monitoring of multi-season responses. Skin, blood, nasal mucosal lining fluid, nasopharyngeal cells, saliva, and skin microbe samples will be collected at various timepoints before and up to 365 days after vaccination to explore short and long-term effects of immunization. Subjects may optionally provide stool samples.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
ID-1day
Participants receive intradermal flu vaccination in the upper arm and will have skin biopsy of vaccination site 1 day after vaccine administration.
Intervention: Fluzone® Quadrivalent
Intramuscular (IM) Control
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.
Intervention: Fluzone® Quadrivalent
ID-2hour
Participants receive intradermal flu vaccination in the upper arm and will have skin biopsy of vaccination site 2 hours after vaccine administration.
Intervention: MicronJet
ID-2hour
Participants receive intradermal flu vaccination in the upper arm and will have skin biopsy of vaccination site 2 hours after vaccine administration.
Intervention: Fluzone® Quadrivalent
ID-6hour
Participants receive intradermal flu vaccination in the upper arm and will have skin biopsy of vaccination site 6 hours after vaccine administration.
Intervention: MicronJet
ID-6hour
Participants receive intradermal flu vaccination in the upper arm and will have skin biopsy of vaccination site 6 hours after vaccine administration.
Intervention: Fluzone® Quadrivalent
ID-1day
Participants receive intradermal flu vaccination in the upper arm and will have skin biopsy of vaccination site 1 day after vaccine administration.
Intervention: MicronJet
ID-3day
Participants receive intradermal flu vaccination in the upper arm and will have skin biopsy of vaccination site 3 days after vaccine administration.
Intervention: MicronJet
ID-3day
Participants receive intradermal flu vaccination in the upper arm and will have skin biopsy of vaccination site 3 days after vaccine administration.
Intervention: Fluzone® Quadrivalent
ID-28day
Participants receive intradermal flu vaccination in the upper arm and will have skin biopsy of vaccination site 3 days after vaccine administration.
Intervention: MicronJet
ID-28day
Participants receive intradermal flu vaccination in the upper arm and will have skin biopsy of vaccination site 3 days after vaccine administration.
Intervention: Fluzone® Quadrivalent
Sal-2hour
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.
Intervention: MicronJet
Sal-2hour
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.
Intervention: Bacteriostatic Saline
Sal-6hour
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.
Intervention: MicronJet
Sal-6hour
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.
Intervention: Bacteriostatic Saline
Sal-1hour
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.
Intervention: MicronJet
Sal-1hour
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.
Intervention: Bacteriostatic Saline
Outcomes
Primary Outcomes
Change in antibody titer concentration to vaccination-Blood
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- Change in antibody titer concentration to vaccination(Day 0 and Day 28)