mRNA-1083 Vaccine for Influenza and COVID-19

Recruiting at 16 trial locations

Overseen By Moderna WeCare Team

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: ModernaTX, Inc.

Must not be taking: Immunosuppressants, Vaccines

Disqualifiers: Unstable conditions, Recent influenza, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 day

1300 Participants Needed

Trial Summary

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 treatment, you may need to stop as it is an exclusion criterion.

What data supports the effectiveness of the mRNA-1083 treatment for Influenza and COVID-19?

The mRNA-1273 vaccine, which is similar to mRNA-1083, has shown to be highly effective in preventing COVID-19, with studies demonstrating strong immune responses and protection against severe disease in both animal models and human trials. ^{1 2 3 4 5}

Is the mRNA-1083 vaccine generally safe for humans?

Research on similar mRNA vaccines, like mRNA-1273 and mRNA-1283, shows they are generally safe in humans, with no serious safety concerns identified. Some mild side effects, like chills and fatigue, are more common with mRNA vaccines compared to traditional flu vaccines, but serious issues are rare. ^{6 7 8 9 10}

How is the mRNA-1083 vaccine different from other treatments for influenza and COVID-19?

The mRNA-1083 vaccine is unique because it combines protection against both COVID-19 and influenza in a single shot, using a novel mRNA technology that encodes specific proteins from both viruses to trigger an immune response. This approach is different from traditional vaccines that typically target only one virus at a time. ^{11 12 13 14 15}

What is the purpose of this trial?

The purpose of this study is to evaluate the immunogenicity, reactogenicity, and safety, of mRNA-1083 multicomponent influenza and COVID-19 vaccine in adults ≥18 to \<65 years of age.

Eligibility Criteria

This trial is for adults aged 18 to less than 65 who are in good health. Specific eligibility criteria aren't provided, but typically participants should not have conditions that could interfere with the vaccine's effects or their ability to complete the study.

Inclusion Criteria

My health condition is currently stable.

I am not pregnant and will use birth control during and after the study.

I've had at least 2 COVID-19 vaccines, with the last one over 150 days ago.

Exclusion Criteria

Received any investigational influenza vaccine, investigational COVID-19 vaccine, or investigational combination vaccine for influenza and COVID-19 within 12 months prior to Day 1

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

Tested positive for influenza by local health authority-approved testing methods within 150 days prior to Day 1

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intramuscular (IM) injection of the assigned vaccine on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for immunogenicity, reactogenicity, and safety after the injection

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• mRNA-1083

Trial Overview The study tests various doses and compositions of mRNA-1083, a new vaccine aimed at preventing both influenza and COVID-19. Participants will receive different versions of this investigational vaccine to assess its immune response and safety.

Participant Groups

Group I: mRNA-1083 Composition 3 Dose B Experimental Treatment 1 Intervention

Participants will receive single IM injection of mRNA-1083 Composition 3 at Dose Level B on Day 1.

Group II: mRNA-1083 Composition 3 Dose A Experimental Treatment 1 Intervention

Participants will receive single IM injection of mRNA-1083 Composition 3 at Dose Level A on Day 1.

Group III: mRNA-1083 Composition 2 Dose B Experimental Treatment 1 Intervention

Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level B on Day 1.

Group IV: mRNA-1083 Composition 2 Dose A Experimental Treatment 1 Intervention

Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level A on Day 1.

Group V: mRNA-1083 Composition 1 Dose C Experimental Treatment 1 Intervention

Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level C on Day 1.

Group VI: mRNA-1083 Composition 1 Dose B Experimental Treatment 1 Intervention

Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level B on Day 1.

Group VII: mRNA-1083 Composition 1 Dose A Lot B Experimental Treatment 1 Intervention

Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level A Lot B on Day 1.

Group VIII: mRNA-1083 Composition 1 Dose A Lot A Experimental Treatment 1 Intervention

Participants will receive single intramuscular (IM) injection of mRNA-1083 Composition 1 at Dose Level A Lot A on Day 1.

Group IX: Investigational Influenza Vaccine Active Control 1 Intervention

Participants will receive single IM injection of Investigational Influenza Vaccine on Day 1.

Group X: Investigational COVID-19 Vaccine Lot A Active Control 1 Intervention

Participants will receive single IM injection of Investigational COVID-19 Vaccine Lot A on Day 1.

Group XI: COVID-19 Vaccine Active Control 1 Intervention

Participants will receive single IM injection of COVID-19 Vaccine on Day 1.

Group XII: Influenza Vaccine Active Control 1 Intervention

Participants will receive single IM injection of Influenza Vaccine on Day 1.

Group XIII: Investigational COVID-19 Vaccine Lot B Active Control 1 Intervention

Participants will receive single IM injection of Investigational COVID-19 Vaccine Lot B 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

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 survey of 2,849 individuals aged 18-49 who completed mRNA COVID-19 vaccinations, about 90% reported adverse events (AEs), with 3.3% after the first dose and 4.3% after the second dose experiencing severe AEs.

Factors associated with a higher incidence of AEs included receiving the mRNA-1273 vaccine, being female, having dermatologic diseases, and a history of serious allergic reactions or anticoagulant medication use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Nationwide Survey of mRNA COVID-19 Vaccinee's Experiences on Adverse Events and Its Associated Factors. Yoon, D., Jeon, HL., Noh, Y., et al.[2023]

In a phase 1 clinical trial involving 104 healthy adults, the mRNA-1283 vaccine was found to be safe, with no serious adverse events reported, indicating a favorable safety profile.

All doses of the mRNA-1283 vaccine (10, 30, and 100 µg) produced strong immune responses comparable to the established mRNA-1273 vaccine, suggesting its potential effectiveness in generating immunity against SARS-CoV-2.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interim analysis of a phase 1 randomized clinical trial on the safety and immunogenicity of the mRNA-1283 SARS-CoV-2 vaccine in adults. Yassini, P., Hutchens, M., Paila, YD., et al.[2023]

The novel combined mRNA vaccine AR-CoV/IAV, which targets both COVID-19 and influenza A, successfully generated strong immune responses in mice, producing protective antibodies and cellular immunity against both viruses.

Immunization with AR-CoV/IAV effectively protected mice from severe outcomes associated with coinfection of influenza A and SARS-CoV-2 variants, demonstrating the potential of this vaccine platform for preventing respiratory diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rational development of a combined mRNA vaccine against COVID-19 and influenza. Ye, Q., Wu, M., Zhou, C., et al.[2023]

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]

References

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

COVID-19 vaccine mRNA-1273 elicits a protective immune profile in mice that is not associated with vaccine-enhanced disease upon SARS-CoV-2 challenge. [2023]

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

mRNA-1273 efficacy in a severe COVID-19 model: attenuated activation of pulmonary immune cells after challenge. [2023]

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

Attenuated activation of pulmonary immune cells in mRNA-1273-vaccinated hamsters after SARS-CoV-2 infection. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Real-world effectiveness of the mRNA-1273 vaccine against COVID-19: Interim results from a prospective observational cohort study. [2022]

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

In high-risk adults, the Moderna vaccine had 94% efficacy against COVID-19 ≥14 d after the 2nd dose. [2021]

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. England pubmed.ncbi.nlm.nih.gov

Analysis of the adverse events following the mRNA-1273 COVID-19 vaccine. [2023]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

A Nationwide Survey of mRNA COVID-19 Vaccinee's Experiences on Adverse Events and Its Associated Factors. [2023]

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

Interim analysis of a phase 1 randomized clinical trial on the safety and immunogenicity of the mRNA-1283 SARS-CoV-2 vaccine in adults. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

A phase 1/2 randomised placebo-controlled study of the COVID-19 vaccine mRNA-1273 in healthy Japanese adults: An interim report. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Rational development of a combined mRNA vaccine against COVID-19 and influenza. [2023]

12. England pubmed.ncbi.nlm.nih.gov

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

13. 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]

14. Spain pubmed.ncbi.nlm.nih.gov

[The new generation of messenger RNA (mRNA) vaccines against influenza]. [2023]

15. Spain pubmed.ncbi.nlm.nih.gov

The new generation of messenger RNA (mRNA) vaccines against influenza. [2023]