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InfluenzaPhase 1NCT07340047

H1ssF Flu Vaccine Clinical Trial

A Phase 1 study testing H1ssF vaccine and Flucelvax seasonal vaccine in people with Influenza, run by University of Minnesota.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a two-arm, open-label, randomized, phase 1, controlled clinical trial intended to evaluate the safety and immunologic response to the experimental vaccine H1ssF (H1 stabilized stem ferritin nanoparticle) and the seasonal flu vaccine Flucelvax. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
H1ssF vaccine and Flucelvax seasonal vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Aug 2026to 1 Mar 2028
Phase
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 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adults aged 18-70 years inclusive.
  • Previous influenza immunization status:
  • MN participants must have received at least 3 licensed seasonal flu vaccine doses over the past 5 years (fall or winter of 2021-2025).
  • MN participants should have a gap of at least 6 months between their last seasonal flu vaccine and study enrollment.
  • Uganda participants must have no prior exposure to any flu vaccine.
  • The participant is able and willing to provide informed consent.
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  • Medical chart review and medical history without clinically significant findings or concerns.
  • Physical examination without clinically significant findings or concerns.
  • Body mass index (BMI) ≤ 30 kg/m2. This inclusion criterion can be voided if the participant is otherwise eligible and the study team finds the participant suitable for the LN biopsy via LN palpation on the physical exam.
  • Screening laboratory results (blood) within institutional normal ranges (unless specified below otherwise). Screening lab tests include: CBCD, comprehensive metabolic panel (i.e., AST, ALT, ALP, BUN, creatinine, glucose, Na, K, Ca, total protein, albumin, total bilirubin), and HIV Ag/Ab test. Acceptance of screening lab results outside of the ranges below will need to be accompanied by a site investigator's approval.
  • Hb ≥ 11 g/dL (males) or ≥ 10.5 g/dL (females).
  • White blood cell (WBC) count in the range of 4,000-11,000 cells/μL.
  • Normal WBC differential per institutional ranges.
  • Total lymphocyte count ≥ 800 cells/μL.
  • Platelet count in the range of 125,000-500,000 cells/μL.
  • Na = 135-145 mmol/L
  • K = 3.4-5.3 mmol/L
  • Creatinine = 0.67-1.28 mg/dL
  • Blood urea nitrogen (BUN) ≤ 20 mg/dL
  • Glucose (non-fasting) = 65-116 mg/dL
  • Ca = 8.6-10.0 mg/dL
  • Total protein ≥ 6.0 g/dL
  • Albumin ≥ 3.5 g/dL
  • Total bilirubin ≤ 1.2 mg/dL
  • ALP ≤ 165 U/L
  • AST ≤ 50 U/L
  • ALT ≤ 87 U/L
  • Negative for HIV infection per study testing (FDA approved method of detection): non-reactive licensed 4th generation (Ag/Ab) HIV rapid test, EIA, or CIA.
  • Women of reproductive potential / premenopausal:
  • Negative beta-human chorionic gonadotropin (β-HCG) urine or serum pregnancy test at screening.
  • Agrees to avoid pregnancy during the study.
  • Agrees to use an effective means of birth control from at least 21 days prior to baseline visit through the end of the study (week 40). Acceptable birth control for this study is defined as:
  • Sexual abstinence with male partners.
  • Surgical sterilization (tubal ligation).
  • Male condom with or without a spermicidal agent.
  • Female condom.
  • Diaphragm or cervical cap.
  • Intrauterine device (IUD) (published data shows that expected failure rate is < 1% per year).
  • Hormone-based contraceptives including oral pills, injectables, implants, rings, and patches.
  • Partner has vasectomy.
  • The participant is agreeable to the following study requirements:
  • The participant should not receive an off-study flu vaccine until they complete the study (40 weeks from enrollment).
  • The participant is available and willing to attend research visits for 40 weeks after enrollment and undergo all study procedures to provide samples, which are to be used for research-only purposes and can be stored indefinitely.
  • The participant is able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
  • The participant should not receive any other investigational research agents until they complete the study.
  • The participant does not foresee becoming ineligible during study participation.

Who cannot join

  • Breast-feeding or planning to become pregnant during the study.
  • Any of the following substances are exclusionary if currently used or planned to be used at any time during the 40-week study period:
  • Systemic immunosuppressive medications within the 4 weeks prior to enrollment (e.g., corticosteroid therapy equal to or exceeding a dose of 15 mg/day of prednisone for more than 10 days, IL-2, interferon, methotrexate, cancer chemotherapy). Use of inhaled, nasal spray, or topical steroids is not exclusionary.
  • Any cytotoxic medications within the 4 weeks prior to enrollment or any within the 14 days prior to enrollment.
  • Blood products within 16 weeks prior to enrollment.
  • Live attenuated vaccines within 4 weeks prior to enrollment.
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  • Inactivated vaccines within 2 weeks prior to enrollment.
  • Investigational research agents within 4 weeks prior to enrollment.
  • Current allergy treatment with allergen immunotherapy with antigen injections, unless on maintenance schedule.
  • Current anti-tuberculosis prophylaxis or therapy.
  • Previous investigational influenza vaccines.
  • Previous investigational ferritin-based vaccines.
  • History of any of the following clinically significant conditions:
  • Severe allergic reactions to influenza vaccines in the past (e.g., Guillain-Barré syndrome, anaphylaxis, or angioedema)
  • Other reactions to any vaccines that preclude receipt of the study vaccination as determined by the investigator.
  • Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema.
  • Asthma that requires prednisone therapy 3 or more times in a 12-month period or rescue inhaler therapy more than weekly.
  • Diabetes mellitus (type I or II), except for gestational diabetes.
  • Thyroid disease that is not well controlled.
  • Idiopathic urticaria within the past year.
  • Autoimmune disease or immunodeficiency.
  • Hypertension that is not well controlled (baseline systolic > 140 mmHg or diastolic > 90 mmHg).
  • Bleeding disorder diagnosed by a healthcare professional (e.g., factor deficiency, coagulopathy, or platelet disorder) or significant bruising or bleeding difficulties with IM injections or blood draws.
  • Active malignancy requiring systemic chemotherapy or surgery within preceding 12 months or expected during study participation. Minor surgical removal of localized skin cancers (squamous cell carcinoma, basal cell carcinoma) is permitted.
  • Seizure disorder other than 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 12 months ago, or 3) seizures that have not required treatment within the last 12 months.
  • Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen.
  • Guillain-Barré Syndrome.
  • Current/active infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
  • Any medical, psychiatric, social condition, occupational reason, or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation, puts participant at risk, influences results of the study, or impairs a participant's ability to provide informed consent.
  • History of ≥3 previous inguinal LN biopsies.
  • Not a suitable surgical candidate per investigators' assessment.

About this study

Official title: Clinical Trial of H1ssF Vaccine vs. Seasonal Influenza Vaccine in Previously Unvaccinated Adults and Previously Vaccinated Adults

This is a two-arm, open-label, randomized, phase 1, controlled clinical trial intended to evaluate the safety and immunologic response to the experimental vaccine H1ssF (H1 stabilized stem ferritin nanoparticle) and the seasonal flu vaccine Flucelvax.

Conditions
Influenza
Being tested
H1ssF vaccine, Flucelvax seasonal vaccine
Keywords
Vaccine
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • H1ssF vaccineBiological

    Experimental influenza vaccine

  • Flucelvax seasonal vaccineBiological

    Licensed influenza vaccine

Study groups in NCT07340047
Study groupRoleWhat they receive
H1ssF vaccineExperimentalNot described
Receives: Biological: H1ssF vaccine
Flucelvax seasonal vaccineActive comparatorNot described
Receives: Biological: Flucelvax seasonal vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of solicited local reactogenicity for 7 days after vaccine administration

    Number of participants with solicited local symptoms per protocol

    Measured: Day 7

  2. Occurrence of solicited systemic reactogenicity for 7 days after vaccine administration

    Number of participants with solicited systemic symptoms per protocol

    Measured: Day 7

  3. Occurrence of adverse events of all severities from baseline through 1-week follow-up after the 2nd LN biopsy on week 4 study visit

    Number of participants with any adverse event through week 5

    Measured: Week 5

  4. Occurrence of serious adverse events at any time throughout the study

    Number of participants with any serious adverse event throughout the study

    Measured: Week 40

Secondary outcomes (2)

  1. Binding antibody responses to H1ssF at week 2 after vaccination in both cohorts (US and Uganda)

    Antibody titer to H1ssF at week 2 after vaccination

    Measured: Week 2

  2. Binding antibody responses to the Flucelvax HAs at week 2 after vaccination in both cohorts (US and Uganda)

    Antibody titer to H1ssF at week 2 after vaccination

    Measured: Week 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2026
  2. Study start1 Aug 2026 (estimated)
  3. Primary completion1 Mar 2028 (estimated)
  4. Study completion1 Mar 2028 (estimated)

Why it stopped: Study did not open for enrollment. The principal investigator is moving to another institution, and next steps. The FDA IND has been withdrawn and the study has been closed with the UMN IRB.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07340047
Sponsor's protocol ID
IDIM-2025-31286
Status last verified
Sep 2026
First submitted
9 Dec 2025
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing H1ssF vaccine and Flucelvax seasonal vaccine in people with Influenza, run by University of Minnesota.

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 46 inclusion and 31 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: withdrawn, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 was withdrawn before enrolling participants, so there are no results.

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?

Occurrence of solicited local reactogenicity for 7 days after vaccine administration (time frame: Day 7). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07340047.

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 21 Sep 2026.

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