Characterization of Immune Response to Intradermal Influenza Vaccination

Status: Recruiting
Location: See location...
Intervention Type: Device, Biological, Other
Study Type: Interventional
Study Phase: Early Phase 1
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. 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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: t
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‣ In order to be eligible to participate in this study, an individual must meet all of the following criteria:

• 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

• a. 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

‣ Individuals meeting any of the following criteria will be excluded from study participation:

• 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).

⁃ BMI ≥ 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.

Locations
United States
Connecticut
Church Street Research Unit
RECRUITING
New Haven
Contact Information
Primary
Andrew Johnston, MD, PhD
Andrew.d.johnston@yale.edu
203-745-0216
Time Frame
Start Date: 2024-01-24
Estimated Completion Date: 2026-05
Participants
Target number of participants: 249
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Yale University
Collaborators: Chan Zuckerberg Initiative, Silicon Valley Community Foundation, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), University of Chicago

This content was sourced from clinicaltrials.gov

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