Health TrialsbyHealthPanel

Intradermal Influenza Vaccination

ConditionVaccine Reaction
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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • MicronJet

    Device

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

  • Fluzone® Quadrivalent

    Biological/Vaccine

    Intradermal injections of 0.3mL

  • Fluzone® Quadrivalent

    Biological/Vaccine

    Intramuscular injection of 0.3mL

  • Bacteriostatic Saline

    Other intervention

    Intradermal injection of 0.3mL (control)

Treatment groups

249 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: Intramuscular (IM) ControlActive comparator 1 intervention
Group B: ID-2hourExperimental treatment 2 interventions
Group C: ID-6hourExperimental treatment 2 interventions
Group D: ID-1dayExperimental treatment 2 interventions
Group E: ID-3dayExperimental treatment 2 interventions
Group F: ID-28dayExperimental treatment 2 interventions
Group G: Sal-2hourPlacebo comparator 2 interventions
Group H: Sal-6hourPlacebo comparator 2 interventions
Group I: Sal-1hourPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Source ClinicalTrials.gov
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