Actively Recruiting

Early Phase 1
Age: 18Years - 40Years
All Genders
Healthy Volunteers
NCT06067555

Intradermal Influenza Vaccination

Led by Yale University · Updated on 2025-06-19

249

Participants Needed

1

Research Sites

118 weeks

Total Duration

On this page

Sponsors

Y

Yale University

Lead Sponsor

C

Chan Zuckerberg Initiative

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Intradermal Influenza Vaccination

Who Can Participate

Age: 18Years - 40Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed and dated informed consent form
  • Willingness to follow all study procedures and availability for the study duration
  • Ability to speak, read, and write English proficiently
  • Male or female, aged 18 to 40 years at enrollment
  • Allowed to participate in future influenza seasons even if older than 40
  • In good general health based on medical history
Not Eligible

You will not qualify if you...

  • Abnormal lab test results deemed significant by the study doctor
  • Positive HIV 1/2 antibody screening
  • Received current seasonal influenza vaccine for this season
  • History of allergy or severe reaction to vaccine components such as egg protein
  • Use of oral glucocorticoids in past 30 days
  • Received live-attenuated vaccine in past 3 months
  • Received any experimental vaccine
  • Received other vaccines (non-live, non-experimental) in past 3 months
  • Planned vaccination within 100 days after study vaccine
  • Use of immunoglobulin therapy in past 90 days
  • Surgery within past 8 weeks or planned before day 28
  • Current treatment for cancer or chemotherapy in past 2 years
  • Blood product administration within 90 days or planned before day 100
  • History of parasitic, fungal, or mycobacterial infections in past year except minor skin infections
  • History of autoimmune or autoinflammatory diseases, especially skin-related
  • History of keloids or bleeding disorders
  • Use of illicit drugs in past 30 days except marijuana
  • Alcohol use disorder in past 30 days
  • Serious uncontrolled infection in past 30 days
  • History of Guillain-Barre syndrome
  • Body mass index of 30 or higher
  • Known or suspected immunodeficiency including HIV in past year
  • Pregnancy or planning pregnancy during study
  • Any condition that may put participant at risk or affect study results as judged by the investigator

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Church Street Research Unit

New Haven, Connecticut, United States, 06519

Actively Recruiting

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Research Team

A

Andrew Johnston, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

9

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