Intradermal Influenza Vaccination

Inclusion Criteria

• •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• •1. Provision of signed and dated informed consent form
• •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.