RecruitingEarly Phase 1NCT06067555

Intradermal Influenza Vaccination

Characterization of Immune Response to Intradermal Influenza Vaccination


Sponsor

Yale University

Enrollment

249 participants

Start Date

Jan 24, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Bacteriostatic Saline, a biological treatment called Fluzone® Quadrivalent, and others for people with vaccine reaction. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 40 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMicronJet

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

BIOLOGICALFluzone® Quadrivalent

Intradermal injections of 0.3mL

BIOLOGICALFluzone® Quadrivalent

Intramuscular injection of 0.3mL

OTHERBacteriostatic Saline

Intradermal injection of 0.3mL (control)


Locations(1)

Church Street Research Unit

New Haven, Connecticut, United States

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NCT06067555


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