Not Yet RecruitingPhase 1

H1ssF Flu Vaccine Clinical Trial

United States112 participantsStarted 2026-08-01

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. 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.

Exclusion criteria

✕. 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.
✕. 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.

What they're measuring

Occurrence of solicited local reactogenicity for 7 days after vaccine administration

Timeframe: Day 7

Occurrence of solicited systemic reactogenicity for 7 days after vaccine administration

Timeframe: Day 7

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

Timeframe: Week 5

Occurrence of serious adverse events at any time throughout the study

Timeframe: Week 40

Trial details

NCT IDNCT07340047

SponsorUniversity of Minnesota

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03-01

Contact for this trial

Kevin Escandon, MD, MS

612-624-9344 escan012@umn.edu

View on ClinicalTrials.gov More Influenza trials

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. 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.

Exclusion criteria

✕. 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.
✕. 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.

What they're measuring

Occurrence of solicited local reactogenicity for 7 days after vaccine administration

Timeframe: Day 7

Occurrence of solicited systemic reactogenicity for 7 days after vaccine administration

Timeframe: Day 7

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

Timeframe: Week 5

Occurrence of serious adverse events at any time throughout the study

Timeframe: Week 40