H1ssF + Flucelvax for Flu

Overseen By Kevin Escandon, MD, MS

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Minnesota

Must not be taking: Immunosuppressants, Cytotoxics, Allergy injections, others

Disqualifiers: Pregnancy, Diabetes, Hypertension, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

Tim Schacker, MD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 who are in good health, with a BMI ≤ 30 kg/m2. Minnesotans must have had at least three flu shots in the last five years and not received one within six months before joining. Ugandans can't have had any flu vaccines before. Everyone must be willing to consent and pass medical reviews.

Inclusion Criteria

Uganda participants must have no prior exposure to any flu vaccine

I am between 18 and 70 years old.

Screening laboratory results within institutional normal ranges

Exclusion Criteria

Breastfeeding or planning to become pregnant during the study

History of ≥3 previous inguinal LN biopsies

I have been deemed not suitable for surgery by my doctor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the H1ssF vaccine or the Flucelvax seasonal vaccine

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and immunologic response after vaccination

40 weeks

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• H1ssF

Trial Overview

The study compares two flu vaccines: H1ssF (experimental) and Flucelvax (seasonal). Participants will be randomly assigned to receive either vaccine, allowing researchers to assess safety and immune responses.

How Is the Trial Designed?

Group I: H1ssF vaccine Experimental Treatment 1 Intervention

Group II: Flucelvax seasonal vaccine Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+