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 trial tests the safety and immune response of a new flu vaccine, H1ssF, compared to the usual flu shot, Flucelvax. Researchers aim to evaluate the effectiveness and safety of these vaccines. The trial suits adults who have received at least three flu shots in the past five years or have never received a flu vaccine, depending on location, and are generally healthy without major medical issues. Participants must commit to attending regular study visits and avoid other flu vaccines during the trial. As a Phase 1 trial, this research focuses on understanding how the new vaccine works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

Do I need to stop taking my current medications for the trial?

You may need to stop certain medications before joining the trial. Specifically, you cannot use systemic immunosuppressive medications, cytotoxic medications, blood products, live attenuated vaccines, inactivated vaccines, investigational research agents, or certain allergy treatments during the study. Check with the study team for details on your specific medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the H1ssF vaccine is generally safe and well-tolerated. In earlier studies, most side effects were mild, such as temporary soreness at the injection site and mild flu-like symptoms, which are common with many vaccines. No reports of serious side effects have emerged.

Flucelvax, an approved seasonal flu vaccine, has been used for a while. Its safety profile is well established, with most people experiencing only mild side effects, such as soreness at the injection site, mild headache, or fatigue.

Overall, studies have demonstrated that both the H1ssF and Flucelvax vaccines are safe, with mostly mild and short-lasting side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard flu vaccines that use inactivated or weakened viruses to stimulate an immune response, the H1ssF vaccine is unique because it targets the stem of the influenza virus's hemagglutinin protein. This approach aims to provide broader protection against different flu strains, potentially addressing the challenge of virus mutations that often make traditional vaccines less effective. Researchers are excited about the H1ssF vaccine because it could lead to more universal flu protection, reducing the need for annual updates and improving vaccine efficacy.

What evidence suggests that this trial's treatments could be effective for flu?

Research shows that the experimental H1ssF vaccine, which participants in this trial may receive, helps the body produce antibodies that recognize and fight various flu viruses. This broad protection is crucial because current flu vaccines range from 10% to 60% effectiveness, depending on their match with circulating flu strains. Early results suggest that H1ssF might offer more consistent protection. Specifically, previous patients had more antibodies against the flu, indicating this vaccine could strengthen the immune system's defense. While more research is needed, these early findings offer hope for a more reliable flu vaccine. ^{1 6 7 8 9}

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+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07340047

NCT07340047 | H1ssF Flu Vaccine Clinical Trial

This is a two-arm, open-label, randomized, phase 1, controlled clinical trial intended to evaluate the safety and immunologic response to ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11629632/

Recent advances in the influenza virus vaccine landscape

For each vaccine technology, a brief history of the development is given, followed by the key characteristics and a summary of the available clinical outcome ...

3.

sciencemediacentre.es

sciencemediacentre.es/en/reactions-phase-1-trial-new-prototype-universal-flu-vaccine

Reactions to Phase 1 trial of a new prototype universal flu ...

H1ssF vaccine increased group 1 influenza binding antibodies in all age groups. In general, currently licensed influenza vaccines are less ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0264410X2500996X

Qualification of a reporter virus microneutralization assay ...

Influenza vaccines help reduce influenza associated morbidity and mortality, but vaccine effectiveness estimates range from 10 %–60 % by ...

5.

insight.jci.org

insight.jci.org/articles/view/194932

H1N1 challenge results in rapid recall of stem-specific ...

This necessitates yearly updates, with variable effectiveness (10%–60%) based on the success of the inclusion of strains matching those in ...

6.

trialx.com

trialx.com/clinical-trials/listings/280521/a-study-to-evaluate-26/

A Study to Evaluate the Safety and Immunogenicity ...

This study is designed to assess the safety and immunogenicity of one dose of H1ssF 3928 mRNA Vaccine. Eligible participants will be ...

7.

niaid.nih.gov

niaid.nih.gov/news-events/vrc-uni-flu-vax

Universal Influenza Candidate Vaccine Performs Well in ...

The H1ssF vaccine is unique in that it only displays the stem part of the influenza HA protein on the surface of a nanoparticle made of nonhuman ...

8.

science.org

science.org/doi/10.1126/scitranslmed.ade4790

An influenza hemagglutinin stem nanoparticle vaccine ...

The H1ssF vaccine was safe and well tolerated, with mild reported solicited local and systemic reactogenicity (Fig. 2). The only local ...

9.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05755620

NCT05755620 | A Study to Evaluate the Safety and ...

This study is designed to assess the safety and immunogenicity of one dose of H1ssF 3928 mRNA Vaccine. Eligible participants will be sequentially enrolled ...