Intradermal Influenza Vaccination

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-40
SponsorYale University

About this trial

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 criteria

Qualifiers

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study, as well as have deidentified samples and data stored for future research.

Able to proficiently speak, read, and write English.

Male or female, aged 18-40 years old at time of initial enrollment

Disqualifiers

None

Trial design

Treatments tested in this trial

  • MicronJet
  • Fluzone® Quadrivalent
  • Fluzone® Quadrivalent
  • Bacteriostatic Saline

Treatment groups

249 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Sponsors and collaborators

Yale University

Lead sponsor

Chan Zuckerberg Initiative

Collaborator

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

Collaborator

Silicon Valley Community Foundation

Collaborator

University of Chicago

Collaborator