Vaccine ReactionEarly Phase 1NCT06067555
Intradermal Influenza Vaccination- Healthy Cohort
A Early Phase 1 study testing MicronJet, Fluzone® Quadrivalent and Bacteriostatic Saline in people with Vaccine Reaction, run by Yale University at 1 site in United States.
Trial 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 compared to intramuscular vaccination and placebo. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccine Reaction
- What is being tested?
- MicronJet, Fluzone® Quadrivalent and Bacteriostatic Saline
- Type of treatment
- Vaccines, Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2024to 26 Feb 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- 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
Who cannot join
- 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.
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- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Church Street Research Unit
New Haven, Connecticut, 06519
About this study
Official title: Characterization of Immune Response to Intradermal Influenza Vaccination
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 compared to intramuscular vaccination and placebo. 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.
Read the detailed description
Participants are evaluated before vaccination and followed longitudinally after vaccination. Participants may also provide optional stool samples. The primary immunogenicity measurement is the change in influenza microneutralization antibody titers between Day 0 and Day 28.
- Conditions
- Vaccine Reaction
- Being tested
- MicronJet, Fluzone® Quadrivalent, Bacteriostatic Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicronJetDevice
MicronJet 600 syringe will be used to administer intradermal flu vaccine injections
Fluzone® QuadrivalentBiological
Intradermal injections of 0.3mL
Fluzone® QuadrivalentBiological
Intramuscular injection of 0.3mL
Bacteriostatic SalineOther
Intradermal injection of 0.3mL (control)
| Study group | Role | What they receive |
|---|---|---|
| Intradermal saline | Placebo comparator | Healthy participants will receive intradermal saline injection. Receives: Device: MicronJet; Other: Bacteriostatic Saline |
| Intradermal flu vaccine | Active comparator | Healthy participants will receive intradermal flu vaccine injection. Receives: Device: MicronJet; Biological: Fluzone® Quadrivalent |
| Intramuscular flu | Experimental | Healthy participants will receive intramuscular flu vaccine injection. Receives: Device: MicronJet; Biological: Fluzone® Quadrivalent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 and Day 28
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.
Measured: 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.
Measured: Day 0 and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start24 Jan 2024
- Primary completion26 Feb 2025
- Study completion26 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine ReactionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Chan Zuckerberg Initiative, Silicon Valley Community Foundation, University of Chicago, Yale Development Award
- Responsible party
- Sponsor
- Investigators
- Andrew Johnston, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067555
- Sponsor's protocol ID
- 2000035891
- Status last verified
- Oct 2026
- First submitted
- 27 Sep 2023
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified data in an NIH-funded or approved public repository, including genetic data in the database of Genotypes and Phenotypes (dbGaP); gene expression and chromatin profiling data in the National Center for Biotechnology Information (NCBI) Gene Expression Omnibus (GEO); sequencing data in the NCBI Sequence Read Archive (SRA); flow cytometry data in FlowRepository. De-identified or identified data with approved outside collaborators under appropriate agreements.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Immune Response to Intradermal Influenza Vaccination
- ClinicalTrials.gov ID
- NCT06067555
- Acronym / sponsor ID
- 2000035891
- Conditions
- Vaccine Reaction
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Chan Zuckerberg Initiative, Silicon Valley Community Foundation, University of Chicago, Yale Development Award
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 26 Feb 2025 (actual)
- Study completion
- 26 Feb 2025 (actual)
- First posted
- 5 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 compared to intramuscular vaccination and placebo. 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.
Detailed description
Participants are evaluated before vaccination and followed longitudinally after vaccination. Participants may also provide optional stool samples. The primary immunogenicity measurement is the change in influenza microneutralization antibody titers between Day 0 and Day 28.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intradermal saline | Placebo comparator | Device: MicronJet, Other: Bacteriostatic SalineHealthy participants will receive intradermal saline injection. |
| Intradermal flu vaccine | Active comparator | Device: MicronJet, Biological: Fluzone® QuadrivalentHealthy participants will receive intradermal flu vaccine injection. |
| Intramuscular flu | Experimental | Device: MicronJet, Biological: Fluzone® QuadrivalentHealthy participants will receive intramuscular flu vaccine injection. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
- 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
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicronJetMicronJet 600 syringe will be used to administer intradermal flu vaccine injections | Device | Intradermal flu vaccine, Intradermal saline, Intramuscular flu |
| Fluzone® QuadrivalentIntradermal injections of 0.3mL | Biological | Intradermal flu vaccine |
| Fluzone® QuadrivalentIntramuscular injection of 0.3mL | Biological | Intramuscular flu |
| Bacteriostatic SalineIntradermal injection of 0.3mL (control) | Other | Intradermal saline |
Primary outcome
Change in antibody titer concentration to vaccination-Blood
Time frame: Day 0 and Day 28
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.
Change in antibody titer concentration to vaccination-Skin
Time frame: Day 0 and Day 28
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.
1 secondary outcome
Change in antibody titer concentration to vaccination
Time frame: Day 0 and Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified data in an NIH-funded or approved public repository, including genetic data in the database of Genotypes and Phenotypes (dbGaP); gene expression and chromatin profiling data in the National Center for Biotechnology Information (NCBI) Gene Expression Omnibus (GEO); sequencing data in the NCBI Sequence Read Archive (SRA); flow cytometry data in FlowRepository. De-identified or identified data with approved outside collaborators under appropriate agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Johnston principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing MicronJet, Fluzone® Quadrivalent and Bacteriostatic Saline in people with Vaccine Reaction, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in antibody titer concentration to vaccination-Blood (time frame: Day 0 and Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.