NCT06067555

Intradermal Influenza Vaccination

Characterization of Immune Response to Intradermal Influenza Vaccination

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 249 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Vaccine Reaction

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2024-01-24
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2023-10-05
• Last updated: 2025-06-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study