Vaccine ReactionEarly Phase 1NCT07908329
Intradermal Influenza Vaccination
A Early Phase 1 study testing MicronJet, Fluzone® Quadrivalent and Fluzone® High Dose Quadrivalent 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. The intervention involves intradermal administration of an FDA-approved intramuscular seasonal influenza vaccine, using an FDA-approved device MicronJet. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccine Reaction
- What is being tested?
- MicronJet, Fluzone® Quadrivalent and Fluzone® High Dose Quadrivalent
- Type of treatment
- Vaccines, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to May 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Participant is allowed to participate in subsequent influenza seasons even if they will be >40 years old.
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- 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).
Who cannot join
- 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.
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- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
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. 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
This is a single-site, prospective, open-label, exploratory study designed to characterize local and systemic immune responses to seasonal influenza vaccination. Seasonal influenza vaccination is used as a controlled immune challenge to identify baseline and early post-vaccination features associated with the magnitude, kinetics, and durability of the immune response. The study includes three participant arms based on medical history: healthy adults, patients with cancer who are preparing to begin immune checkpoint inhibitor therapy, and adults with physician-diagnosed post-acute infection syndrome (PAIS), including long COVID and long Lyme disease or post-treatment Lyme disease syndrome.
Participants receive a season-appropriate Fluzone influenza vaccine. Depending on the study arm and cohort, the vaccine is administered either intradermally using a MicronJet600 microneedle device or intramuscularly. The vaccine is approved for intramuscular administration; its intradermal administration in this study is an off-label use conducted under an exemption from an Investigational New Drug application. Intradermal participants receive a 0.3 mL dose. Intramuscular participants receive the dose specified for their cohort and influenza season.
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.
Cancer and PAIS arms are exploratory.
- Conditions
- Vaccine Reaction
- Being tested
- MicronJet, Fluzone® Quadrivalent, Fluzone® High Dose Quadrivalent
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
Fluzone® High Dose QuadrivalentBiological
For participants >65 years old
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Active comparator | Healthy participants will receive either intramuscular or intradermal flu vaccination. Receives: Device: MicronJet; Biological: Fluzone® Quadrivalent; Biological: Fluzone® High Dose Quadrivalent |
| Cancer (Exploratory Arm) | Other | Cancer patients about to undergo Immune Checkpoint Inhibitor (ICI) therapy will receive either intramuscular or intradermal flu vaccination. Receives: Device: MicronJet; Biological: Fluzone® Quadrivalent; Biological: Fluzone® High Dose Quadrivalent |
| Post acute infection syndrome (PAIS) (Exploratory Arm) | Other | PAIS patients will receive either intramuscular or intradermal flu vaccination Receives: Device: MicronJet; Biological: Fluzone® Quadrivalent; Biological: Fluzone® High Dose 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 posted2 Nov 2026
- Study start1 Oct 2026
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
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
- Model description
- Please see the detailed study description regarding the different arms and study visit design for each.
- Masking
- None (open label)
- Enrolment
- 139 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Chan Zuckerberg Initiative, Silicon Valley Community Foundation, Yale Development Award
- Responsible party
- Sponsor
- Investigators
- Andrew Johnston, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908329
- Sponsor's protocol ID
- 2000035891_a
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 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 2 Nov 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
- NCT07908329
- Acronym / sponsor ID
- 2000035891_a
- Conditions
- Vaccine Reaction
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 139 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Chan Zuckerberg Initiative, Silicon Valley Community Foundation, Yale Development Award
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 2 Nov 2026 (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. 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
This is a single-site, prospective, open-label, exploratory study designed to characterize local and systemic immune responses to seasonal influenza vaccination. Seasonal influenza vaccination is used as a controlled immune challenge to identify baseline and early post-vaccination features associated with the magnitude, kinetics, and durability of the immune response. The study includes three participant arms based on medical history: healthy adults, patients with cancer who are preparing to begin immune checkpoint inhibitor therapy, and adults with physician-diagnosed post-acute infection syndrome (PAIS), including long COVID and long Lyme disease or post-treatment Lyme disease syndrome.
Participants receive a season-appropriate Fluzone influenza vaccine. Depending on the study arm and cohort, the vaccine is administered either intradermally using a MicronJet600 microneedle device or intramuscularly. The vaccine is approved for intramuscular administration; its intradermal administration in this study is an off-label use conducted under an exemption from an Investigational New Drug application. Intradermal participants receive a 0.3 mL dose. Intramuscular participants receive the dose specified for their cohort and influenza season.
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.
Cancer and PAIS arms are exploratory.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Please see the detailed study description regarding the different arms and study visit design for each.
| Arm | Type | Receives |
|---|---|---|
| Healthy | Active comparator | Device: MicronJet, Biological: Fluzone® Quadrivalent, Biological: Fluzone® High Dose QuadrivalentHealthy participants will receive either intramuscular or intradermal flu vaccination. |
| Cancer (Exploratory Arm) | Other | Device: MicronJet, Biological: Fluzone® Quadrivalent, Biological: Fluzone® High Dose QuadrivalentCancer patients about to undergo Immune Checkpoint Inhibitor (ICI) therapy will receive either intramuscular or intradermal flu vaccination. |
| Post acute infection syndrome (PAIS) (Exploratory Arm) | Other | Device: MicronJet, Biological: Fluzone® Quadrivalent, Biological: Fluzone® High Dose QuadrivalentPAIS patients will receive either intramuscular or intradermal flu vaccination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 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.
- Male or female, aged 18-40 years old at time of initial enrollment
- In good general health as evidenced by medical history
Key exclusion criteria (62 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 | Cancer (Exploratory Arm), Healthy, Post acute infection syndrome (PAIS) (Exploratory Arm) |
| Fluzone® QuadrivalentIntradermal injections of 0.3mL | Biological | Cancer (Exploratory Arm), Healthy, Post acute infection syndrome (PAIS) (Exploratory Arm) |
| Fluzone® QuadrivalentIntramuscular injection of 0.3mL | Biological | Cancer (Exploratory Arm), Healthy, Post acute infection syndrome (PAIS) (Exploratory Arm) |
| Fluzone® High Dose QuadrivalentFor participants >65 years old | Biological | Cancer (Exploratory Arm), Healthy, Post acute infection syndrome (PAIS) (Exploratory Arm) |
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
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 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.
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 Fluzone® High Dose Quadrivalent 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 18 inclusion and 62 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: looking for participants now, as of the sponsor's last update on 2 Nov 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew Johnston, MD, PhD (203-745-0216, Andrew.d.johnston@yale.edu), or a site near the patient. 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 2 Nov 2026.