FluMos-v2 Vaccine for Flu

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: Immunosuppressives, Cytotoxics, Anti-TB, 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: 13

Duration: 16 weeks

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new flu vaccine, FluMos-v2, to evaluate its effectiveness with and without an adjuvant called ALFQ, which can enhance the vaccine's efficacy. Researchers aim to determine the safety and effectiveness of these combinations in preventing flu. The trial seeks healthy adults aged 18–50 who have received at least one flu shot between the 2020-21 and 2024-25 seasons and are willing to forgo the 2025-26 flu vaccine. Participants will visit the clinic 12 times over 15 months, receive two shots, maintain a symptom diary, and provide blood, saliva, and nasal samples for research. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new vaccine.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on systemic immunosuppressive or cytotoxic medications, you may need to stop them at least 14 days before enrolling. It's best to discuss your specific medications with the study team.

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

In earlier studies, researchers tested the safety of the FluMos-v2 vaccine, both alone and with an added substance called ALFQ. The main aim was to determine if people could use these treatments without major problems. So far, studies have shown that the vaccine, with or without ALFQ, is safe and well-tolerated in healthy adults.

Participants reported mild side effects, such as soreness at the injection site, mild fever, or fatigue. These symptoms are common with many vaccines and usually resolve on their own after a few days.

As a Phase 1 study, the primary focus is on safety. Researchers closely monitor how participants react to the vaccine. While promising evidence indicates that both FluMos-v2 and ALFQ are safe, ongoing research continues to assess this and gather more information. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the FluMos-v2 vaccine because it offers a fresh approach to flu prevention. Unlike traditional flu vaccines that require annual updates to match circulating strains, FluMos-v2 aims to provide broader protection by targeting multiple flu virus components at once. Additionally, some trial groups receive a combination of FluMos-v2 with ALFQ, an adjuvant that potentially boosts the immune response, possibly enhancing vaccine effectiveness. This innovative strategy could lead to a flu vaccine that is more effective and longer-lasting, reducing the need for yearly vaccinations.

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

Research shows that the FluMos-v2 vaccine is designed to protect against various flu types by helping the immune system recognize different parts of the virus. Early results suggest that similar vaccines have successfully reduced flu symptoms and the amount of virus in the body. In this trial, some participants will receive FluMos-v2 alone, while others will receive it combined with the experimental ingredient ALFQ. Using FluMos-v2 with ALFQ might enhance the body's immune response. Previous studies on other vaccines with similar ingredients have shown improved effectiveness. While more information is needed, these early signs are promising for FluMos-v2 and its potential to provide strong flu protection. ^{1 2 3 4 6}

Who Is on the Research Team?

Lasonji A Holman, C.R.N.P.

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've had at least one flu shot between the 2020-21 and 2023-24 seasons. Participants must skip the licensed flu vaccine for the 2025-26 season. Ideal candidates are willing to attend multiple clinic visits, receive injections, and provide blood, saliva, and nasal samples.

Inclusion Criteria

In good general health without a history of conditions listed in the exclusion criteria

I have received a flu shot between the 2020-2021 and 2023-2024 seasons.

Available for clinic visits for 68 weeks after enrollment, including through the 2025-2026 influenza season

Exclusion Criteria

Breastfeeding or planning to become pregnant during the study

I plan to or must get the flu vaccine for 2025-2026 or received it for 2024-2025.

I have not received any inactivated vaccines in the last 2 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive the FluMos-v2 vaccine with or without ALFQ adjuvant at Day 0 and Week 16

16 weeks

2 visits (in-person), follow-up calls after each vaccination

Follow-up

Participants are monitored for safety and effectiveness after treatment, including through the 2025-2026 influenza season

52 weeks

10 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• ALFQ
• VRC-FLUMOS0116-00-VP

Trial Overview The trial is testing FluMos-v2, an experimental flu vaccine with or without ALFQ adjuvant. Over a period of about 15 months with approximately twelve clinic visits, participants will receive two shots into their upper arm muscles and may choose to undergo apheresis after vaccination.

How Is the Trial Designed?

Group I: Group 3B Experimental Treatment 2 Interventions

180 mcg of FluMos-v2 + 0.5 ml of ALFQ Day 0 and Week 16

Group II: Group 3A Experimental Treatment 2 Interventions

180 mcg of FluMos-v2 + 0.5 ml of ALFQ Day 0 and Week 16

Group III: Group 2 Experimental Treatment 2 Interventions

60 mcg of FluMos-v2 + 0.5 ml of ALFQ Day 0 and Week 16

Group IV: Group 1 Experimental Treatment 1 Intervention

180 mcg of FluMos-v2 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+

Published Research Related to This Trial

The FLU-v vaccine candidate, which targets cellular immunity, was found to be safe and well tolerated in a phase Ib trial involving 32 male participants, with significant increases in FLU-v-specific immune responses observed 19 days post-vaccination.

Participants who received FLU-v showed reduced viral loads and symptom scores after being challenged with the influenza virus, indicating that enhanced cellular immunity correlates with better clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Synthetic Influenza Virus Vaccine Induces a Cellular Immune Response That Correlates with Reduction in Symptomatology and Virus Shedding in a Randomized Phase Ib Live-Virus Challenge in Humans. Pleguezuelos, O., Robinson, S., Fernández, A., et al.[2018]

The MVA-NP+M1 influenza vaccine significantly boosted T-cell responses in healthy adults, demonstrating its immunogenicity after a single dose, which is crucial for effective protection against influenza.

In a controlled challenge study, vaccinees experienced milder symptoms and shorter virus shedding duration compared to controls, indicating the vaccine's potential efficacy in reducing influenza severity and transmission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary assessment of the efficacy of a T-cell-based influenza vaccine, MVA-NP+M1, in humans. Lillie, PJ., Berthoud, TK., Powell, TJ., et al.[2022]

The VN1203delNS1 vaccine candidate, developed from the H5N1 strain A/Vietnam/1203/04, has shown promising safety and immunogenicity in both mouse and macaque models.

This vaccine works by deleting the NS1 protein, which normally helps the virus evade the immune system, suggesting it could provide effective cross-protection against various H5N1 virus clades.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Preclinical studies of live intranasal H5N1 influenza vaccine with the deleted HS1 gene]. Romanovskaia-Roman'ko, EA., Ferko, B., Vyshemirskiĭ, OI., et al.[2019]

A vaccinia-based influenza vaccine that targets conserved internal proteins successfully broadened T-cell immunity in mice, allowing for a stronger immune response against various influenza strains.

This vaccine provided significant protection against both closely related and more distant influenza strains, demonstrating its potential as a broadly protective option against unpredictable influenza pandemics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaccinia-based influenza vaccine overcomes previously induced immunodominance hierarchy for heterosubtypic protection. Kwon, JS., Yoon, J., Kim, YJ., et al.[2014]

The study evaluated a seasonal trivalent virosomal vaccine adjuvated with Matrix-M, showing that it provided some protection against avian influenza H5 and H7 strains in mice and ferrets, although the protection was not complete.

In ferrets challenged with H5N1, the vaccine reduced viral loads and lung pathology, suggesting that this adjuvated vaccine could serve as a temporary measure to lessen the impact of a potential pandemic outbreak.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Matrix-M Adjuvated Seasonal Virosomal Influenza Vaccine Induces Partial Protection in Mice and Ferrets against Avian H5 and H7 Challenge. Cox, F., Roos, A., Hafkemeijer, N., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06863142

Study Details | NCT06863142 | Evaluating the Dose, Safety ... This is a Phase I, open-label, dose escalation study to evaluate the dose, safety, tolerability, and immunogenicity of mosaic hexavalent influenza vaccine VRC- ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05968989?term=NCT05968989

Study Details | NCT05968989 | Trial to Evaluate the Safety, ... This is a Phase I, open-label, dose escalation study to evaluate the dose, safety, tolerability, and immunogenicity of the mosaic hexavalent influenza vaccine ...

3. trialx.com trialx.com/clinical-trials/listings/297383/evaluating-the-dose-safety-tolerability-and-immunogenicity-of-mosaic-hexavalent-influenza-vaccine-vrcflumos0116-00-vp-flumos-v2-with-and-without-alfq-adjuvant-in-healthy-adults/

Clinical Research Trial Listing ( Influenza Prevention This is a Phase I, open-label, dose escalation study to evaluate the dose, safety, tolerability, and immunogenicity of mosaic hexavalent influenza vaccine.

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06863142/evaluating-the-dose-safety-tolerability-and-immunogenicity-of-mosaic-hexavalent-influenza-vaccine-vrcflumos0116-00-vp-flumos-v2-with-and-without-alfq-adjuvant-in-healthy-adults

Evaluating the Dose, Safety, Tolerability, and ... This is a Phase I, open-label, dose escalation study to evaluate the dose, safety, tolerability, and immunogenicity of mosaic hexavalent influenza vaccine VRC- ...

5. niaid.nih.gov niaid.nih.gov/clinical-trials/experimental-influenza-vaccine-flumos-v2-study

Experimental Influenza Vaccine (FluMos-v2) Study | NIAID The primary purpose of this study is to see if the experimental influenza (flu) vaccine called the FluMos-v2 vaccine is safe, and to determine ...

6. trialx.com trialx.com/clinical-trials/listings/248959/trial-to-evaluate-the-safety-tolerability-and-immunogenicity-of-a-mosaic-hexavalent-influenza-vaccine-vrc-flumos0116-00-vp-flumos-v2-in-healthy-adults/

Clinical Research Trial Listing ( Influenza ) ( NCT05968989 ) This is a Phase I, open-label, dose escalation study to evaluate the dose, safety, tolerability, and immunogenicity of the mosaic hexavalent ...