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Intradermal Influenza Vaccination- Healthy Cohort

Characterization of Immune Response to Intradermal Influenza Vaccination

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06067555
Enrollment
42
Registered
2023-10-05
Start date
2024-01-24
Completion date
2025-02-26
Last updated
2026-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaccine Reaction

Brief 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 compared to intramuscular vaccination and placebo. 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.

Detailed description

Participants are evaluated before vaccination and followed longitudinally after vaccination. Participants may also provide optional stool samples. The primary immunogenicity measurement is the change in influenza microneutralization antibody titers between Day 0 and Day 28.

Interventions

DEVICEMicronJet

MicronJet 600 syringe will be used to administer intradermal flu vaccine injections

Intradermal injections of 0.3mL

Intradermal injection of 0.3mL (control)

Sponsors

Yale University
Lead SponsorOTHER
Chan Zuckerberg Initiative
CollaboratorOTHER
Silicon Valley Community Foundation
CollaboratorOTHER
University of Chicago
CollaboratorOTHER
Yale Development Award
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

Inclusion: * 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. * Participant is allowed to participate in subsequent influenza seasons even if they will be \>40 years old. * In good general health as evidenced by medical history Exclusion: * CBC with differential, lymphocyte phenotyping with T, B, and natural killer cells (TBNK), complete metabolic panel, anti-CMV immunoglobulin (Ig) G and IgM, and/or anti-Epstein-Barr virus (EBV) antibody panel values outside of the Yale Department of Laboratory Medicine normal reference ranges and deemed clinically significant by the PI at the time of screening. * Positive result for anti-HIV 1/2 antibody screening at the time of screening. * Prior receipt of a current seasonal influenza vaccine (for the season of participation). * History of allergy or hypersensitivity to any components of the study vaccine (e.g., egg protein). * History of severe reactions to vaccines. * Use of an oral glucocorticoid within the past 30 days. * Receipt of a live-attenuated vaccine within the past 3 months. * Receipt of any experimental vaccine. * Receipt of any other type of vaccine (non-live and non-experimental, e.g., tetanus, diphtheria, and pertussis \[TDaP\]) within the past 3 months. * Planned vaccination before day 100 after study vaccination. * Current or recent use (within the past 90 days) of immunoglobulin therapy. * Surgery within the past 8 weeks, or planned surgery before day 28. * Current (within the past 30 days) treatment for active malignancy. * Cancer chemotherapy in the past 2 years. * Administration of any blood products within 90 days of the screening, or planned administration before day 100. * History of parasitic, amebic, fungal, or mycobacterial infections within the past 1 year, with the exception of tinea pedis and onychomycosis. * History of autoimmune or autoinflammatory disease. a. In particular skin-related (i.e. psoriasis, lichen planus, lupus, neutrophilic dermatoses, atopic dermatitis) * History of keloids * History of a bleeding disorder. * Current use (within the past 30 days) of illicit drugs (per subject report), with the exception of marijuana. * Current alcohol use disorders (criteria per Diagnostic and Statistical Manual of Mental Disorders, fifth edition), within the past 30 days. * Serious, ongoing, uncontrolled infection within the past 30 days as per the judgement of the PI. * History of Guillain-Barre syndrome (GBS). * Body Mass Index ≥ 30. * Known or suspected immunodeficiency within 1 year, including documented HIV infection. * Pregnancy or planning to become pregnant during the study period. (Women of childbearing potential must have a negative urine or serum pregnancy test at screening.) * Presence of conditions that, in the judgment of the PI, may put the individual at undue risk or compromise the scientific objectives of the study. 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.

Design outcomes

Primary

MeasureTime frameDescription
Change in antibody titer concentration to vaccination-BloodDay 0 and Day 28Change 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.
Change in antibody titer concentration to vaccination-SkinDay 0 and Day 28Change 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.

Secondary

MeasureTime frameDescription
Change in antibody titer concentration to vaccinationDay 0 and Day 28Change 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAndrew Johnston

Yale University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 30, 2026