H1ssF Flu Vaccine Clinical Trial

NCT07340047 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: IDIM-2025-31286
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Influenza

Keywords

Vaccine

Outcome Measures

Primary Outcomes (4)

• Occurrence of solicited local reactogenicity for 7 days after vaccine administration

  Number of participants with solicited local symptoms per protocol

  Day 7

• Occurrence of solicited systemic reactogenicity for 7 days after vaccine administration

  Number of participants with solicited systemic symptoms per protocol

  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

  Number of participants with any adverse event through week 5

  Week 5

• Occurrence of serious adverse events at any time throughout the study

  Number of participants with any serious adverse event throughout the study

  Week 40

Secondary Outcomes (2)

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

  Week 2

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

  Week 2

Study Arms (2)

H1ssF vaccine

EXPERIMENTAL

Biological: H1ssF vaccine

Flucelvax seasonal vaccine

ACTIVE COMPARATOR

Biological: Flucelvax seasonal vaccine

Interventions

H1ssF vaccine BIOLOGICAL

Experimental influenza vaccine

H1ssF vaccine

Flucelvax seasonal vaccine BIOLOGICAL

Licensed influenza vaccine

Flucelvax seasonal vaccine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Medical chart review and medical history without clinically significant findings or concerns.
• Physical examination without clinically significant findings or concerns.
• 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

You may not qualify if:

• Breast-feeding or planning to become pregnant during the study.
• 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.
• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Tim Schacker, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin Escandon, MD, MS

CONTACT

612-624-9344; escan012@umn.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: January 14, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)