Intradermal Influenza Vaccination

Conditions

• Vaccine Reaction

Eligibility Criteria

Sex

ALL

Age

18 Years - 40 Years

Healthy Volunteers

Accepted

Interventions

• MicronJet — DEVICE
  MicronJet 600 syringe will be used to administer intradermal flu vaccine injections
• Fluzone® Quadrivalent — BIOLOGICAL
  Intradermal injections of 0.3mL
• Fluzone® Quadrivalent — BIOLOGICAL
  Intramuscular injection of 0.3mL
• Bacteriostatic Saline — OTHER
  Intradermal injection of 0.3mL (control)

Study Details

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.

Key Dates

Start date

Jan 24, 2024

Status verified

Jun 2025

Primary completion

May 31, 2026

Completion

May 31, 2026

Study Design

Enrollment

249 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Active Comparator: Intramuscular (IM) Control
  An intramuscular control group, from which no skin biopsies will be taken after vaccination. Only the intramuscular cohort will receive the flu vaccine via standard IM route in the deltoid region of the upper arm.
• Experimental: ID-2hour
  Participants receive intradermal flu vaccination in the upper arm and will have skin biopsy of vaccination site 2 hours after vaccine administration.
• Experimental: ID-6hour
  Participants receive intradermal flu vaccination in the upper arm and will have skin biopsy of vaccination site 6 hours after vaccine administration.
• Experimental: ID-1day
  Participants receive intradermal flu vaccination in the upper arm and will have skin biopsy of vaccination site 1 day after vaccine administration.
• Experimental: ID-3day
  Participants receive intradermal flu vaccination in the upper arm and will have skin biopsy of vaccination site 3 days after vaccine administration.
• Experimental: ID-28day
  Participants receive intradermal flu vaccination in the upper arm and will have skin biopsy of vaccination site 3 days after vaccine administration.
• Placebo Comparator: Sal-2hour
  A control group in which bacteriostatic saline is injected intradermally in lieu of influenza vaccine. A skin biopsy will be taken from the "vaccination" site 2 hours after administration.
• Placebo Comparator: Sal-6hour
  A control group in which bacteriostatic saline is injected intradermally in lieu of influenza vaccine. A skin biopsy will be taken from the "vaccination" site 6 hours after administration.
• Placebo Comparator: Sal-1hour
  A control group in which bacteriostatic saline is injected intradermally in lieu of influenza vaccine. A skin biopsy will be taken from the "vaccination" site 1 day after administration.

Primary Outcome Measure

Change in antibody titer concentration to vaccination-Blood [ Time Frame: Day 0 and Day 28 ]

Central Contacts

• Andrew Johnston, MD, PhD
  203-745-0216
  [email protected]

Locations (1)

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