Flu Vaccine for Influenza

Not currently recruiting at 24 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Sanofi Pasteur, a Sanofi Company

Must not be taking: Immunosuppressants, Corticosteroids, Anticoagulants, others

Disqualifiers: Immunodeficiency, Myocarditis, Guillain-Barré, others

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

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new flu vaccine designed to be more effective by using mRNA technology to target multiple flu virus strains. Researchers aim to assess the vaccine's safety and its ability to help the body fight the flu compared to existing vaccines. The study includes several groups, each receiving a different version of the new vaccine (Hexavalent Influenza mRNA Vaccine) or a standard flu shot for comparison. Individuals who have received a flu vaccine in the past six months or have certain health conditions, such as a history of severe allergic reactions or specific heart issues, may not be eligible to participate. The trial seeks adults aged 50 and older who do not have these health conditions. As a Phase 1, Phase 2 trial, this study focuses on understanding how the vaccine works in people and measuring its effectiveness in an initial group, offering participants a chance to contribute to groundbreaking research.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy or long-term systemic corticosteroids, you may not be eligible to participate.

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

Research has shown that the hexavalent influenza mRNA vaccine and its ingredients have generally been well-tolerated in past studies. No serious side effects or deaths related to these vaccines were reported within six months after vaccination. Mild reactions, such as pain at the injection site, headache, and tiredness, have been more common but are not considered serious.

For the TIV mRNA-HA Vaccine 1, about 70% of people experienced mild side effects, including pain and swelling at the injection site, headache, and muscle aches. These reactions are typical and expected with vaccines.

The TIV mRNA-NA component has also proven to be safe. A small number of people reported mild side effects like a burning sensation in the mouth, but no serious problems were linked to the vaccine.

Overall, while mild reactions are common, no serious safety concerns have been identified for these investigational treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the hexavalent influenza mRNA vaccine because it represents a novel approach to fighting the flu. Unlike traditional flu vaccines, which typically use inactivated or weakened viruses, this vaccine uses mRNA technology to teach the body how to recognize and fight the flu virus. This method could potentially offer a more robust and versatile immune response. Additionally, the hexavalent mRNA vaccine combines multiple components to target different parts of the virus, which may enhance its effectiveness and broaden protection. The use of mRNA technology also allows for faster updates to the vaccine in response to emerging flu strains, offering a significant advantage over current options.

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

Research has shown that mRNA flu vaccines, such as the hexavalent influenza mRNA vaccine in this trial, yield promising results in enhancing the body's defense against flu strains. Participants may receive various combinations of the hexavalent vaccine, which studies have found to offer strong protection against severe flu cases, particularly those requiring hospitalization, especially in high-risk groups like older adults. Previous data suggest these vaccines can produce strong antibodies, aiding the body in fighting the flu virus.

For participants receiving the TIV mRNA-HA and TIV mRNA-NA vaccines, similar mRNA flu vaccines have proven more effective than traditional flu vaccines, with some studies noting better protection rates. Overall, this trial carefully examines these mRNA vaccines for their ability to provide robust defense against flu viruses, potentially offering better protection than standard flu vaccines. ^{6 7 8 9 10}

Who Is on the Research Team?

Clinical Sciences & Operations

Principal Investigator

Sanofi

Are You a Good Fit for This Trial?

This trial is for adults aged 50 or older who are in good health. Women must be postmenopausal, surgically sterile, or willing to use effective contraception. Participants need a negative pregnancy test before receiving the study vaccine.

Inclusion Criteria

I agree to use effective birth control or abstain from sex starting 4 weeks before until 12 weeks after the treatment.

I am 50 years old or older.

I am not able to have children because I am postmenopausal or have been surgically sterilized.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intramuscular injection of the hexavalent influenza mRNA vaccine or active control

1 day

1 visit (in-person) on Day 01

Follow-up

Participants are monitored for safety and immunogenicity, including solicited and unsolicited adverse events, and antibody titers

12 months

Visits on Day 03, Day 09, Day 29, Day 181, and a telephone call on Day 366

What Are the Treatments Tested in This Trial?

Interventions

• Hexavalent Influenza mRNA Vaccine

Trial Overview The study tests different formulations of a hexavalent influenza mRNA vaccine against standard and high-dose quadrivalent flu vaccines. It measures safety and immune response after one intramuscular injection in participants.

How Is the Trial Designed?

Group I: Group 9 - TIV mRNA-HA Vaccine 2 Experimental Treatment 1 Intervention

Participants will receive single dose of TIV mRNA-HA Vaccine 2

Group II: Group 8 - TIV mRNA-NA Experimental Treatment 1 Intervention

Participants will receive a single dose of TIV mRNA-NA

Group III: Group 7 - TIV mRNA-HA Vaccine 1 Experimental Treatment 1 Intervention

Participants will receive a single dose of TIV mRNA-HA Vaccine 1

Group IV: Group 6 - Hexavalent (Combination 6) Experimental Treatment 2 Interventions

Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 6)

Group V: Group 5 - Hexavalent (Combination 5) Experimental Treatment 2 Interventions

Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 5)

Group VI: Group 4 - Hexavalent (Combination 4) Experimental Treatment 2 Interventions

Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 4)

Group VII: Group 3 - Hexavalent (Combination 3) Experimental Treatment 2 Interventions

Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 3)

Group VIII: Group 2 - Hexavalent (Combination 2) Experimental Treatment 2 Interventions

Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 2)

Group IX: Group 1 - Hexavalent (Combination 1) Experimental Treatment 2 Interventions

Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 1)

Group X: Group 10 - QIV-SD Active Control 1 Intervention

Participants will receive single dose of QIV-SD vaccine (for participants 50 to 64 years of age only)

Group XI: Group 11 - QIV-HD Active Control 1 Intervention

Participants will receive single dose of QIV-HD vaccine

Who Is Running the Clinical Trial?

Sanofi Pasteur, a Sanofi Company

Lead Sponsor

Trials

429

Recruited

6,140,000+

Paul Hudson

Sanofi Pasteur, a Sanofi Company

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Dr. Thomas Triomphe

Sanofi Pasteur, a Sanofi Company

Chief Medical Officer since 2020

MD from Tehran University of Medical Sciences

Published Research Related to This Trial

A quadrivalent mRNA vaccine targeting four seasonal influenza virus strains was shown to induce strong antibody responses in mice, with effective protection against illness even at low doses (as low as 1 μg per antigen).

The mRNA vaccine demonstrated the ability to prevent weight loss and protect against morbidity and mortality from influenza, highlighting its potential as a promising alternative to traditional influenza vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seasonal quadrivalent mRNA vaccine prevents and mitigates influenza infection. Kackos, CM., DeBeauchamp, J., Davitt, CJH., et al.[2023]

The newly developed mRNA-lipid nanoparticle vaccine targets all 20 known influenza A virus subtypes and influenza B virus lineages, showing promise in eliciting strong immune responses in mice and ferrets.

This multivalent vaccine not only produced high levels of cross-reactive antibodies but also provided protection against both matched and mismatched viral strains, suggesting its potential effectiveness against diverse influenza viruses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multivalent nucleoside-modified mRNA vaccine against all known influenza virus subtypes. Arevalo, CP., Bolton, MJ., Le Sage, V., et al.[2023]

The quadrivalent mRNA-1010 vaccine demonstrated strong humoral immunogenicity, eliciting higher hemagglutination inhibition (HAI) titers against influenza A strains compared to a standard inactivated vaccine, indicating its potential effectiveness in preventing influenza.

No significant safety concerns were reported during the trial, although mild adverse reactions were more common with mRNA-1010, suggesting it is generally safe for use in healthy adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of a phase 1/2 randomized clinical trial of a quadrivalent, mRNA-based seasonal influenza vaccine (mRNA-1010) in healthy adults: interim analysis. Lee, IT., Nachbagauer, R., Ensz, D., et al.[2023]

mRNA vaccines for influenza have been shown to induce strong and long-lasting immunity in both very young and very old mice, demonstrating their potential effectiveness across age groups.

These vaccines not only provide protection against influenza A virus but also target multiple viral antigens, suggesting they could serve as cross-protective vaccines, similar in efficacy to licensed vaccines in larger animals like pigs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protective efficacy of in vitro synthesized, specific mRNA vaccines against influenza A virus infection. Petsch, B., Schnee, M., Vogel, AB., et al.[2021]

Annual influenza vaccination is the largest vaccination effort in the USA, with ongoing discussions about moving towards universal vaccination strategies.

While there is substantial safety data, rare serious adverse events, such as Guillain-Barré syndrome linked to the 1976-1977 vaccine and oculorespiratory syndrome in Canada, highlight the need for continuous monitoring of vaccine safety, especially during pandemic situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring the safety of annual and pandemic influenza vaccines: lessons from the US experience. Iskander, J., Broder, K.[2008]

In a study of 98 elderly individuals in Brazil, 84.7% of reported post-vaccination events were classified as non-severe, with local reactions being the most common (64.3%).

The findings highlight the importance of providing targeted information to healthcare providers to ensure safe vaccination practices and minimize avoidable adverse events in the elderly population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adverse events following immunization against influenza the in elderly in Brazil]. Rodrigues, D., de Marchi Bacellos de Dalri, RC.[2023]

Citations

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An mRNA-based seasonal influenza vaccine in adults The efficacy profile of mRNA-1010 was generally reflective of immunogenicity findings, with higher immune responses against influenza A strains ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0042682224001466

A combination influenza mRNA vaccine candidate ... We constructed a universal influenza vaccine that encodes three influenza antigens. Influenza mRNA vaccine effectively protects mice from the H1N1 challenge.

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Systematic-review-update-enhanced-seasonal flu-vaccines.pdf The response to standard influenza vaccine is reduced, especially among groups that are at higher risk of a severe disease outcome, such as the elderly and ...

4. cdc.gov cdc.gov/mmwr/volumes/73/wr/mm7339a1.htm

Interim Effectiveness Estimates of 2024 Southern ... The 2024 Southern Hemisphere seasonal influenza vaccine reduced the risk for influenza-associated hospitalization among high-risk groups by 35%.

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Immunogenicity and safety of mRNA-based seasonal ... We report first-in-human findings from a phase 1/2 study of mRNA-based seasonal influenza vaccines targeting both HA and NA (mRNA-1020 and mRNA-1030) in ...

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Immunogenicity and safety of mRNA-based seasonal ... Through 6 months, no deaths or serious adverse events were related to vaccination with mRNA-1020 or mRNA-1030 at any dose. These findings ...

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A phase 3 randomized safety and immunogenicity trial of ... Solicited adverse reactions were more frequent with receipt of mRNA-1010; adverse reactions were lower in frequency and severity among adults ...

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Safety and immunogenicity of mRNA-based seasonal ... We aimed to evaluate the safety and immunogenicity of three next-generation seasonal influenza mRNA vaccines with different compositions that encode for ...

9. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2825813

Safety of Simultaneous vs Sequential mRNA COVID-19 ... The findings support simultaneous administration of mRNA COVID-19 and inactivated influenza vaccines as an acceptable option to achieve timely vaccination.

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Safety and immunogenicity of a phase 1/2 randomized ... No safety concerns were identified; solicited adverse reactions were dose-dependent and more frequent after receipt of mRNA-1010 than the active ...