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Intradermal Influenza Vaccination

NCT06067555 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 249

Last updated 2025-06-19

No results posted yet for this study

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.

Conditions

  • Vaccine Reaction

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)

Sponsors & Collaborators

  • Chan Zuckerberg Initiative

    collaborator OTHER

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    collaborator NIH

  • Silicon Valley Community Foundation

    collaborator OTHER

  • University of Chicago

    collaborator OTHER

  • Yale University

    lead OTHER

Principal Investigators

  • Andrew Johnston · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-24
Primary Completion
2026-05-31
Completion
2026-05-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06067555 on ClinicalTrials.gov