NCT07908329 Intradermal Influenza Vaccination
| NCT ID | NCT07908329 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Yale University |
| Condition | Vaccine Reaction |
| Study Type | INTERVENTIONAL |
| Enrollment | 139 participants |
| Start Date | 2026-10-01 |
| Primary Completion | 2029-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 139 participants in total. It began in 2026-10-01 with a primary completion date of 2029-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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
Inclusion: Healthy Arm: * 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 Cancer Arm: * 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. * Deemed eligible to receive an influenza vaccine by their treating oncologist/oncological team. Their oncology team will also determine that the patient's participation in the study will not impact their clinical care or participation in other clinical trials. PAIS Arm: * 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. * Deemed eligible to receive an influenza vaccine by their referring provider. * Documentation of infection (i.e. COVID-19, Lyme). Exclusion: Healthy Arm: * 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. Cancer Arm: * CBC with differential, 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 Hepatitis B/C, tuberculosis, or anti-HIV 1/2 antibody at the time of screening. * Prior receipt of a current seasonal influenza vaccine (for the season of participation) within the past 3 months. * History of allergy or hypersensitivity to any components of the study vaccine (e.g., egg protein). * History of severe reactions to vaccines. * Active (episodes in the last year) autoimmune disease, such as but not limited to, vitiligo, hypothyroidism, multiple sclerosis, scleroderma, rheumatoid arthritis, and Grave's disease. * 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). * 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 allowed, so that participants can consider other trials with potentially life-saving cancer therapies. Study staff should still be notified of co-enrollment to any other protocol. PAIS Arm: * CBC with differential, 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 Hepatitis B/C, tuberculosis, or anti-HIV 1/2 antibody at the time of screening. * Prior receipt of a current seasonal influenza vaccine (for the season of participation) within the past 3 months. * History of allergy or hypersensitivity to any components of the study vaccine (e.g., egg protein). * History of severe reactions to vaccines. * Active (episodes in the last year) autoimmune disease, such as but not limited to, vitiligo, hypothyroidism, multiple sclerosis, scleroderma, rheumatoid arthritis, and Grave's disease. * History of keloids * 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). * 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 allowed. Study staff should still be notified of co-enrollment to any other protocol.
Contact & Investigator
Andrew Johnston
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT07908329 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Vaccine Reaction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07908329 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07908329 currently recruiting?
Yes, NCT07908329 is actively recruiting participants. Contact the research team at Andrew.d.johnston@yale.edu for enrollment information.
Where is the NCT07908329 trial being conducted?
This trial is being conducted at New Haven, United States.
Who is sponsoring the NCT07908329 clinical trial?
NCT07908329 is sponsored by Yale University. The principal investigator is Andrew Johnston at Yale University. The trial plans to enroll 139 participants.