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Clinical Trial 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.


Clinical Trial 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, 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06067555
Study type Interventional
Source Yale University
Contact Andrew Johnston, MD, PhD
Phone 203-889-6634
Email Andrew.d.johnston@yale.edu
Status Recruiting
Phase Early Phase 1
Start date January 24, 2024
Completion date May 2026

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