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RECRUITING
NCT06067555
EARLY_PHASE1

Intradermal Influenza Vaccination

Sponsor: Yale University

View on ClinicalTrials.gov

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.

Official title: Characterization of Immune Response to Intradermal Influenza Vaccination

Key Details

Gender

All

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

249

Start Date

2024-01-24

Completion Date

2026-05

Last Updated

2025-06-19

Healthy Volunteers

Yes

Interventions

DEVICE

MicronJet

MicronJet 600 syringe will be used to administer intradermal flu vaccine injections

BIOLOGICAL

Fluzone® Quadrivalent

Intradermal injections of 0.3mL

BIOLOGICAL

Fluzone® Quadrivalent

Intramuscular injection of 0.3mL

OTHER

Bacteriostatic Saline

Intradermal injection of 0.3mL (control)

Locations (1)

Church Street Research Unit

New Haven, Connecticut, United States