mRNA Vaccine for Flu

Recruiting at 308 trial locations

Overseen By Moderna Clinical Trials Support Center

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: ModernaTX, Inc.

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

Disqualifiers: Immunodeficiency, Malignancy, Anaphylaxis, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The primary objectives of this study are to evaluate the safety and reactogenicity of mRNA-1010, and to evaluate relative vaccine efficacy (rVE) of mRNA-1010 versus an active comparator against protocol-defined influenza-like illness (ILI) caused by any influenza A or B strains.

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

The trial protocol does not specify if you must stop taking your current medications. However, you cannot participate if you have used corticosteroids at ≥10 mg/day of prednisone for more than 14 days within 90 days before the trial, or if you have used systemic immunosuppressive treatments within 180 days before the trial. You also cannot have received any vaccines within 28 days before the trial or plan to receive them within 14 days after the trial starts.

What data supports the idea that mRNA Vaccine for Flu (also known as: mRNA-1010, mRNA-1010) is an effective treatment?

The available research shows that the mRNA Vaccine for Flu, mRNA-1010, is effective because it produces a strong immune response in people. In a study, it was found to create higher levels of protective antibodies against certain flu strains compared to a standard flu vaccine. This means it could potentially offer better protection against the flu. Additionally, in animal studies, the vaccine protected mice from getting sick and even prevented weight loss, which is a sign of illness. These findings suggest that mRNA-1010 is a promising option for preventing the flu. ^{1 2 3 4 5}

What safety data exists for the mRNA flu vaccine?

The safety data for mRNA vaccines, including those for flu, can be inferred from studies on mRNA COVID-19 vaccines. These studies suggest that mRNA vaccines have a different safety profile compared to traditional influenza vaccines, with more systemic reactions like chills and fatigue, but fewer neurological complications. No significant safety concerns have been identified in real-world settings for mRNA vaccines. However, specific safety data for the mRNA flu vaccine, such as mRNA-1010, is not detailed in the provided research. ^{6 7 8 9 10}

Is the mRNA-1010 treatment a promising treatment for the flu?

Yes, mRNA-1010 is a promising treatment for the flu. It has shown to produce strong immune responses against flu strains, similar to or better than traditional flu vaccines, without any major safety concerns. This suggests it could be an effective way to prevent flu infections. ^{1 2 3 4 11}

Eligibility Criteria

This trial is for adults aged 50 years or older. It's designed to test the safety and effectiveness of a new flu vaccine called mRNA-1010 compared to licensed flu vaccines like Fluarix® and Influsplit®.

Inclusion Criteria

Is using an acceptable contraceptive method at least 28 days prior to Day 1 (Baseline) to at least 90 days after Day 1 (Baseline)

I am female or can become pregnant and am eligible to participate.

I cannot become pregnant.

Exclusion Criteria

Tested positive for influenza by local health authority-approved testing methods within 180 days prior to Day 1 (Baseline)

History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures

I have taken high-dose steroids recently or might need them during the study.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single injection of either mRNA-1010 or an active comparator on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to approximately 26 weeks

Treatment Details

Interventions

• mRNA-1010 (Virus Therapy)

Trial Overview The study compares the new mRNA-1010 vaccine with established influenza vaccines. Participants will receive one type of vaccine and be monitored for their body's reaction and protection against flu-like symptoms caused by influenza A or B.

Participant Groups

Group I: mRNA-1010 Experimental Treatment 1 Intervention

Participants will receive a single injection of mRNA-1010 on Day 1.

Group II: Fluarix® or Influsplit® Active Control 2 Interventions

Participants will receive a single injection of active comparator (Fluarix® or Influsplit®) on Day 1.

Who Is Running the Clinical Trial?

ModernaTX, Inc.

Lead Sponsor

Trials

127

Recruited

66,790,000+

Dr. Stephen Hoge

ModernaTX, Inc.

Chief Medical Officer

MD from Harvard Medical School

Stéphane Bancel

ModernaTX, Inc.

Chief Executive Officer since 2011

MBA from Harvard Business School, MSc in Engineering from École Centrale Paris

Findings from Research

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]

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]

A novel mRNA vaccine targeting conserved proteins of the H1N1 influenza virus successfully induced broadly reactive T cells in both naïve and influenza-experienced ferrets, suggesting its potential effectiveness in diverse populations.

The booster vaccination significantly enhanced protection against a different strain of influenza (H7N9), indicating that this mRNA vaccine strategy could provide robust immunity against evolving influenza viruses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A universal influenza mRNA vaccine candidate boosts T cell responses and reduces zoonotic influenza virus disease in ferrets. van de Ven, K., Lanfermeijer, J., van Dijken, H., et al.[2023]

The mRNA-lipid nanoparticle vaccine has been shown to provide protection against 20 different lineages of the influenza virus, indicating its broad efficacy.

This innovative vaccine approach utilizes lipid nanoparticles to deliver mRNA, which instructs cells to produce viral proteins, prompting an immune response that can recognize and combat multiple influenza strains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influenza universe in an mRNA vaccine. Kelvin, AA., Falzarano, D.[2023]

A comparative safety study involving 18,755 individuals vaccinated with mRNA COVID-19 vaccines and 27,895 individuals vaccinated with influenza vaccines found that mRNA vaccines had a different safety profile, with more systemic reactions like chills and fatigue compared to the influenza vaccine.

While mRNA COVID-19 vaccines showed a higher risk for some manageable cardiovascular issues, such as hypertensive crisis and supraventricular tachycardia, they had a lower risk of serious neurological complications compared to influenza vaccines, indicating a generally favorable safety profile for mRNA vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative safety of mRNA COVID-19 vaccines to influenza vaccines: A pharmacovigilance analysis using WHO international database. Kim, MS., Jung, SY., Ahn, JG., et al.[2022]

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]

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]

Cardiac complications, particularly myopericarditis, were the most frequently reported severe adverse events associated with mRNA COVID-19 vaccines, with systemic reactions being more common after the second dose.

Despite the higher number of reported adverse effects following the Pfizer vaccine, the review concluded that the overall benefits of mRNA vaccines in controlling the COVID-19 pandemic significantly outweigh the risks of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Adverse Events Related to COVID-19 mRNA Vaccines; a Systematic Review. SeyedAlinaghi, S., Karimi, A., Pashaei, Z., et al.[2022]

In a retrospective study of 66 individuals who received the H1N1 vaccine during a 2010 mass vaccination campaign in São Paulo, the most common adverse events reported were mild symptoms such as fever, headache, myalgia, and injection site pain.

Importantly, no serious adverse events were reported, indicating that the H1N1 vaccine was generally safe for those vaccinated at this center.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spontaneous reporting of adverse events following pandemic influenza A (H1N1) immunization in a reference center in the State of São Paulo, Brazil. Oliveira, DS., Lara, AN., Luiz, AM., et al.[2022]

Two doses of an mRNA vaccine targeting influenza H10 in rhesus macaques led to strong immune responses, including protective antibody levels and specific T cell activation, indicating its potential efficacy against influenza.

The vaccine induced a rapid immune response characterized by the infiltration of immune cells at the injection site and lymph nodes, which is crucial for generating effective long-term immunity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficient Targeting and Activation of Antigen-Presenting Cells In Vivo after Modified mRNA Vaccine Administration in Rhesus Macaques. Liang, F., Lindgren, G., Lin, A., et al.[2018]

References

1. England 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Protective efficacy of in vitro synthesized, specific mRNA vaccines against influenza A virus infection. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Seasonal quadrivalent mRNA vaccine prevents and mitigates influenza infection. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

A universal influenza mRNA vaccine candidate boosts T cell responses and reduces zoonotic influenza virus disease in ferrets. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

The influenza universe in an mRNA vaccine. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Comparative safety of mRNA COVID-19 vaccines to influenza vaccines: A pharmacovigilance analysis using WHO international database. [2022]

7. Colombia pubmed.ncbi.nlm.nih.gov

[Adverse events following immunization against influenza the in elderly in Brazil]. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Monitoring the safety of annual and pandemic influenza vaccines: lessons from the US experience. [2008]

9. Iran pubmed.ncbi.nlm.nih.gov

Safety and Adverse Events Related to COVID-19 mRNA Vaccines; a Systematic Review. [2022]

10. Brazil pubmed.ncbi.nlm.nih.gov

Spontaneous reporting of adverse events following pandemic influenza A (H1N1) immunization in a reference center in the State of São Paulo, Brazil. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Efficient Targeting and Activation of Antigen-Presenting Cells In Vivo after Modified mRNA Vaccine Administration in Rhesus Macaques. [2018]