Flu Vaccine for Flu Prevention

Overseen By VRC Clinic

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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

Disqualifiers: Uncontrolled asthma, Diabetes, Hypertension, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 12

Duration: 16 weeks

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new flu vaccine, VRC-FLUMOS0122-00-VP (SteMos1), both with and without an adjuvant that may enhance its effectiveness. Researchers aim to find more effective ways to prevent flu, a contagious illness that can cause serious symptoms. Healthy adults aged 18 to 50 who have received at least one flu vaccine since 2020 may qualify to participate. Participants will receive the vaccine, monitor any symptoms, and visit the clinic for follow-ups over approximately 15 months. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new vaccine.

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

The trial does not specify if you need to stop taking your current medications, but it does exclude participants who have taken certain vaccines or medications recently. It's best to discuss your specific medications with the study team to see if they might affect your eligibility.

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

Research shows that the SteMos1 flu vaccine, with and without the ALFQ booster, is being tested for safety and tolerability. In past studies, similar vaccines have been safe for healthy adults. These studies examine the vaccine's effects on the immune system and any potential side effects.

For the SteMos1 vaccine without the booster, studies have found it to be generally safe, with most side effects being mild, such as sore arms or slight fevers. The ALFQ booster is added to enhance the vaccine's effectiveness. So far, researchers are also checking the combination of SteMos1 with ALFQ for any side effects.

As this is an early-stage study, the main goal is to ensure safety. Researchers closely monitor for any negative effects, allowing for early detection and management of reactions.

Overall, while this new combination is being tested, data suggests it is well-tolerated. Participants are closely monitored to ensure their safety throughout the study. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the new flu vaccine, VRC-FLUMOS0122-00-VP (SteMos1), because it offers a novel approach to flu prevention. Unlike traditional flu vaccines that are usually based on inactivated or weakened viruses, SteMos1 is combined with an ALFQ adjuvant, which can enhance the immune response, potentially leading to better protection. The vaccine is tested in different doses, both with and without the adjuvant, providing flexibility and the possibility of optimizing the dose for the best immune response. This could mean more robust and longer-lasting immunity compared to current flu vaccines, making it a promising option for better flu prevention.

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

Research has shown that the new flu vaccine, SteMos1, is designed to protect against four types of flu viruses. Early studies suggest that adding adjuvants, which are special ingredients that enhance vaccine efficacy, can improve the immune response. In this trial, some participants will receive SteMos1 with the ALFQ adjuvant to test its effectiveness, while others will receive SteMos1 without the adjuvant. The aim is to provide stronger protection against the flu, including potential pandemic strains. Although specific human data on SteMos1's effectiveness remains limited, its mechanism suggests it could offer broad protection. ^{1 3 4 5 6}

Who Is on the Research Team?

Lesia K Dropulic, M.D.

Principal Investigator

National Institute of Allergy and Infectious Diseases (NIAID)

Are You a Good Fit for This Trial?

Healthy adults aged 18 to 50 who have received at least one flu vaccine since 2020 are eligible for this trial. It's designed to test a new flu vaccine, with some participants also receiving an adjuvant—a substance that enhances the body's immune response.

Inclusion Criteria

Able and willing to complete the informed consent process

Ability to read and comprehend English

I can attend clinic visits for 68 weeks, including during the 2025-2026 flu season.

Exclusion Criteria

I am not breastfeeding or planning to become pregnant during the study.

I have not received certain substances or vaccines recently.

Received investigational research agents within 4 weeks prior to enrollment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the SteMos1 vaccine with or without ALFQ adjuvant as a 2-dose regimen, with doses administered on Day 0 and Week 16

16 weeks

2 visits (in-person) for vaccination, plus monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including antibody response evaluations and health checks

52 weeks after the second vaccine administration

10 follow-up clinic visits, 4 phone calls

Optional Apheresis

Participants may opt to undergo apheresis for additional immune response analysis

What Are the Treatments Tested in This Trial?

Interventions

• VRC-FLUMOS0122-00-VP (SteMos1) with and without ALFQ Adjuvant

Trial Overview The study is testing a quadrivalent influenza HA stem vaccine called SteMos1, both with and without the ALFQ adjuvant. Participants will be randomly assigned to receive either just the vaccine or the vaccine plus adjuvant in two doses four months apart.

How Is the Trial Designed?

Group I: Group 5- optional Experimental Treatment 1 Intervention

SteMos1 \[dose TBD based on interim analysis of data from Groups 3-4\] + 0.5 ml of ALFQ on Day 0 and Week 16

Group II: Group 4 Experimental Treatment 1 Intervention

180 mcg of SteMos1 + 0.5 ml of ALFQ on Day 0 and Week 16

Group III: Group 3 Experimental Treatment 1 Intervention

60 mcg of SteMos1 + 0.5 ml of ALFQ on Day 0 and Week 16

Group IV: Group 2 Experimental Treatment 1 Intervention

180 mcg of SteMos1 on Day 0 and Week 16

Group V: Group 1 Experimental Treatment 1 Intervention

60 mcg of SteMos1 on Day 0 and Week 16

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07111078

Study Details | NCT07111078 | Quadrivalent Influenza HA ... This is a phase I, open-label, dose escalation study to evaluate the safety, tolerability, and immunogenicity of the stem quadrivalent influenza vaccine ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07111078?aggFilters=status%3A%2Csex%3Am%2Cages%3Aadult%2Chealthy%3Ay&ageRange=34.0y_34.0y

Quadrivalent Influenza HA Stem Vaccine VRC-FLUMOS0122-00 ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

3. patlynk.com patlynk.com/trial/NCT07111078

Quadrivalent Influenza HA Stem Vaccine Safety and ... This study focuses on testing a new flu vaccine called SteMos1, which aims to protect against four types of influenza viruses.

4. trial.medpath.com trial.medpath.com/clinical-trial/a6897c0643d2b9a4/nct07111078-vrc-329-quadrivalent-influenza-ha-stem-vaccine-alfq-adjuvant

Quadrivalent Influenza HA Stem Vaccine VRC-FLUMOS0122-00-VP ... Adjuvants are special salts or fats that help vaccines work better. Researchers are looking for ways to make flu vaccines more effective. Objective: To test a ...

5. withpower.com withpower.com/trial/phase-1-influenza-prevention-8-2025-cebe4

Flu Vaccine for Flu Prevention This Phase 1 medical study run by National Institute of Allergy and Infectious Diseases (NIAID) is evaluating whether VRC-FLUMOS0122-00-VP (SteMos1) with ...

6. clinicalstudies.info.nih.gov clinicalstudies.info.nih.gov/htmlSearchedFile.aspx?Query=Respiratory%20Allergy&status=&gender=Select%20One&Inst=&age=&healthyVolunteer=0

NIH Clinical Center: Search the Studies ... Safety, Tolerability, and Immunogenicity of a Quadrivalent Influenza HA Stem Vaccine VRC-FLUMOS0122-00-VP (STEMos1) with and without ALFQ Adjuvant in Healthy ...