An Early Phase 1 interventional study of MicronJet and Fluzone® Quadrivalent in Vaccine Reaction, sponsored by Yale University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-19.
Sponsored by Yale University · Early Phase 1, Interventional, and Basic science
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.
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.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's planned enrollment of 249 is close to the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Male or female, aged 18-40 years old at time of initial enrollment
a. Participant is allowed to participate in subsequent influenza seasons even if they will be >40 years old.
Individuals meeting any of the following criteria will be excluded from study participation:
History of autoimmune or autoinflammatory disease.
a. In particular skin-related (i.e. psoriasis, lichen planus, lupus, neutrophilic dermatoses, atopic dermatitis)
Co-enrollment guidelines: Co-enrollment in other trials is restricted, other than enrollment on observational studies. Consideration for co-enrollment in trials evaluating the use of a licensed medication will require the approval of the PI. Study staff should be notified of co-enrollment on any other protocol as it may require the approval of the PI.
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.
Biological: Fluzone® Quadrivalent
Participants receive intradermal flu vaccination in the upper arm and will have skin biopsy of vaccination site 2 hours after vaccine administration.
Device: MicronJet · Biological: Fluzone® Quadrivalent
Participants receive intradermal flu vaccination in the upper arm and will have skin biopsy of vaccination site 6 hours after vaccine administration.
Device: MicronJet · Biological: Fluzone® Quadrivalent
Participants receive intradermal flu vaccination in the upper arm and will have skin biopsy of vaccination site 1 day after vaccine administration.
Device: MicronJet · Biological: Fluzone® Quadrivalent
Participants receive intradermal flu vaccination in the upper arm and will have skin biopsy of vaccination site 3 days after vaccine administration.
Device: MicronJet · Biological: Fluzone® Quadrivalent
Participants receive intradermal flu vaccination in the upper arm and will have skin biopsy of vaccination site 3 days after vaccine administration.
Device: MicronJet · Biological: Fluzone® Quadrivalent
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.
Device: MicronJet · Other: Bacteriostatic Saline
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.
Device: MicronJet · Other: Bacteriostatic Saline
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.
Device: MicronJet · Other: Bacteriostatic Saline
MicronJet 600 syringe will be used to administer intradermal flu vaccine injections
Intradermal injections of 0.3mL
Intramuscular injection of 0.3mL
Intradermal injection of 0.3mL (control)
Change in antibody titer concentration to vaccination-Blood
Change in antibody titer to vaccination as measured by microneutralization titers at day 0 and day 28 will be correlated with biomarkers in the blood using generalized estimating equations.
Time frame: Day 0 and Day 28
Change in antibody titer concentration to vaccination-Skin
Change in antibody titer to vaccination as measured by microneutralization titers at day 0 and day 28 will be correlated with biomarkers in the skin at baseline using generalized estimating equations.
Time frame: Day 0 and Day 28
Change in antibody titer concentration to vaccination
Change in antibody titer response to vaccination as measured by microneutralization titers at day 0 and day 28 and its relationship with established baseline biomarkers (CD38+, CD20+, B cell, among others) and post-vaccination biomarkers (plasmablast, among others) in the blood will be correlated using generalized estimating equations.
Time frame: Day 0 and Day 28
Plan to share: Yes — Human data generated in this study will be shared for future research as follows: * De-identified data in an NIH-funded or approved public repository, including * genetic data in the database of Genotypes and Phenotypes (dbGaP). * gene expression and chromatin profiling data in the National Center for Biotechnology Information (NCBI) Gene Expression Omnibus (GEO). * sequencing data in the NCBI Sequence Read Archive (SRA). * flow cytometry data in FlowRepository. * De-identified or identified data with approved outside collaborators under appropriate agreements.
No publications or documents are linked to this record.
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