Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
249 participants
INTERVENTIONAL
2024-01-24
2026-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
After preliminary analysis of the first season, we will choose the two most informative skin biopsy time points (2 hour, 6 hour, Day 1, Day 3, or Day 28) and plan for expansion of these cohorts in subsequent influenza seasons for a total of 100 participants per intradermal influenza vaccination cohort. An IM-control group of N=5 will be kept for each flu season; Therefore the total number of participants will be 249 participants. We will not include saline controls in subsequent seasons.
Participants in saline-control cohorts will be restricted from obtaining flu vaccination until after Day 28; after Day 28, they will be allowed to receive influenza vaccination at their discretion. We will ask and record if and when they received vaccination.
BASIC_SCIENCE
NONE
Study Groups
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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.
Fluzone® Quadrivalent
Intramuscular injection of 0.3mL
ID-2hour
Participants receive intradermal flu vaccination in the upper arm and will have skin biopsy of vaccination site 2 hours after vaccine administration.
MicronJet
MicronJet 600 syringe will be used to administer intradermal flu vaccine injections
Fluzone® Quadrivalent
Intradermal injections of 0.3mL
ID-6hour
Participants receive intradermal flu vaccination in the upper arm and will have skin biopsy of vaccination site 6 hours after vaccine administration.
MicronJet
MicronJet 600 syringe will be used to administer intradermal flu vaccine injections
Fluzone® Quadrivalent
Intradermal injections of 0.3mL
ID-1day
Participants receive intradermal flu vaccination in the upper arm and will have skin biopsy of vaccination site 1 day after vaccine administration.
MicronJet
MicronJet 600 syringe will be used to administer intradermal flu vaccine injections
Fluzone® Quadrivalent
Intradermal injections of 0.3mL
ID-3day
Participants receive intradermal flu vaccination in the upper arm and will have skin biopsy of vaccination site 3 days after vaccine administration.
MicronJet
MicronJet 600 syringe will be used to administer intradermal flu vaccine injections
Fluzone® Quadrivalent
Intradermal injections of 0.3mL
ID-28day
Participants receive intradermal flu vaccination in the upper arm and will have skin biopsy of vaccination site 3 days after vaccine administration.
MicronJet
MicronJet 600 syringe will be used to administer intradermal flu vaccine injections
Fluzone® Quadrivalent
Intradermal injections of 0.3mL
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.
MicronJet
MicronJet 600 syringe will be used to administer intradermal flu vaccine injections
Bacteriostatic Saline
Intradermal injection of 0.3mL (control)
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.
MicronJet
MicronJet 600 syringe will be used to administer intradermal flu vaccine injections
Bacteriostatic Saline
Intradermal injection of 0.3mL (control)
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.
MicronJet
MicronJet 600 syringe will be used to administer intradermal flu vaccine injections
Bacteriostatic Saline
Intradermal injection of 0.3mL (control)
Interventions
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MicronJet
MicronJet 600 syringe will be used to administer intradermal flu vaccine injections
Fluzone® Quadrivalent
Intradermal injections of 0.3mL
Fluzone® Quadrivalent
Intramuscular injection of 0.3mL
Bacteriostatic Saline
Intradermal injection of 0.3mL (control)
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Able to proficiently speak, read, and write English.
4. 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.
5. In good general health as evidenced by medical history
Individuals meeting any of the following criteria will be excluded from study participation:
1. 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.
2. Positive result for anti-HIV 1/2 antibody screening at the time of screening.
3. Prior receipt of a current seasonal influenza vaccine (for the season of participation).
4. History of allergy or hypersensitivity to any components of the study vaccine (e.g., egg protein).
5. History of severe reactions to vaccines.
6. Use of an oral glucocorticoid within the past 30 days.
7. Receipt of a live-attenuated vaccine within the past 3 months.
8. Receipt of any experimental vaccine.
9. Receipt of any other type of vaccine (non-live and non-experimental, e.g., tetanus, diphtheria, and pertussis \[TDaP\]) within the past 3 months.
10. Planned vaccination before day 100 after study vaccination.
11. Current or recent use (within the past 90 days) of immunoglobulin therapy.
12. Surgery within the past 8 weeks, or planned surgery before day 28.
13. Current (within the past 30 days) treatment for active malignancy.
14. Cancer chemotherapy in the past 2 years.
15. Administration of any blood products within 90 days of the screening, or planned administration before day 100.
16. History of parasitic, amebic, fungal, or mycobacterial infections within the past 1 year, with the exception of tinea pedis and onychomycosis.
17. History of autoimmune or autoinflammatory disease.
a. In particular skin-related (i.e. psoriasis, lichen planus, lupus, neutrophilic dermatoses, atopic dermatitis)
18. History of keloids
19. History of a bleeding disorder.
20. Current use (within the past 30 days) of illicit drugs (per subject report), with the exception of marijuana.
21. Current alcohol use disorders (criteria per Diagnostic and Statistical Manual of Mental Disorders, fifth edition), within the past 30 days.
22. Serious, ongoing, uncontrolled infection within the past 30 days as per the judgement of the PI.
23. History of Guillain-Barre syndrome (GBS).
24. BMI ≥ 30.
25. Known or suspected immunodeficiency within 1 year, including documented HIV infection.
26. 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.)
27. 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.
18 Years
40 Years
ALL
Yes
Sponsors
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Chan Zuckerberg Initiative
OTHER
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
Silicon Valley Community Foundation
OTHER
University of Chicago
OTHER
Yale University
OTHER
Responsible Party
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Principal Investigators
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Andrew Johnston
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Church Street Research Unit
New Haven, Connecticut, United States
Countries
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Central Contacts
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Other Identifiers
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2000035891
Identifier Type: -
Identifier Source: org_study_id
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