mRNA Vaccine for COVID-19 and Flu

No longer recruiting at 15 trial locations

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: ModernaTX, Inc.

Must not be taking: Corticosteroids, Immunosuppressants, others

Disqualifiers: Chronic conditions, Immunodeficiency, 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: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a new mRNA vaccine, mRNA-1083, designed to protect against both COVID-19 and the flu. Participants will receive one of several versions of the vaccine to evaluate its efficacy and the body's response. The trial seeks adults aged 50 to under 65 who received a flu shot last season. Those with chronic medical conditions or a history of severe vaccine reactions may not be eligible. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to important vaccine development.

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 corticosteroids or systemic immunosuppressive treatments, you may need to stop or adjust them as per the trial's exclusion criteria.

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

Research has shown that mRNA-1083 was safe in earlier studies. These studies compared mRNA-1083 to regular flu and COVID-19 vaccines. It not only met safety standards but also triggered a strong immune response, indicating it was well-tolerated and effective against both the flu and COVID-19.

Although detailed safety data for this trial phase is not yet available, the ongoing testing of mRNA-1083 suggests that earlier studies deemed it safe enough to proceed. By this stage, the treatment typically has not caused serious side effects in participants. This is encouraging for those considering joining the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about mRNA-1083 because it combines protection against both COVID-19 and the flu in one shot. This is different from the usual vaccines, which typically target each virus separately, like the standard flu shot and COVID-19 vaccines. mRNA-1083 uses messenger RNA technology, which instructs cells to produce proteins that trigger an immune response, potentially offering a more efficient and quicker way to generate immunity. This dual-action approach could simplify vaccinations by reducing the number of shots people need, making it more convenient and potentially increasing vaccination rates.

What evidence suggests that this trial's treatments could be effective for COVID-19 and flu?

Research has shown that the mRNA-1083 vaccine, administered in different formulations in this trial, promises protection against both COVID-19 and the flu. This vaccine triggers strong defenses in the body against the viruses causing these illnesses. Studies have found that the immune response from this vaccine matches or surpasses that of receiving separate shots for each disease. This combined vaccine aims to protect against both with just one shot. Early results suggest it could be a convenient and effective choice for adults. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This clinical trial is for adults aged between 50 and 65 who are in good health. The study aims to test a new vaccine targeting COVID-19 and the flu.

Inclusion Criteria

I am not able to become pregnant.

I understand and can follow the study's requirements.

I can sign the consent form and follow the study's requirements.

Exclusion Criteria

I haven't taken immune-weakening drugs in the last 6 months.

I have been vaccinated against COVID-19 within the last 90 days.

I have a condition that increases my risk for severe flu complications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive a single intramuscular injection of mRNA-1083 (Lot A, B, C, or D) on Day 1

1 day

1 visit (in-person)

Treatment Part 2

Participants receive a single intramuscular injection of mRNA-1083 (Lot A or E) on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• mRNA-1083

Trial Overview The trial is testing mRNA-1083, a combined vaccine for SARS-CoV-2 (the virus that causes COVID-19) and influenza. Participants will receive one intramuscular injection of the vaccine.

How Is the Trial Designed?

Group I: Part 2 Group 6: mRNA-1083 Lot E Experimental Treatment 1 Intervention

Participants will receive mRNA-1083 Lot E as a single injection on Day 1 in Part 2.

Group II: Part 2 Group 5: mRNA-1083 Lot A Experimental Treatment 1 Intervention

Participants will receive mRNA-1083 Lot A as a single injection on Day 1 in Part 2.

Group III: Part 1 Group 4: mRNA-1083 Lot D Experimental Treatment 1 Intervention

Participants will receive mRNA-1083 Lot D as a single injection on Day 1 in Part 1.

Group IV: Part 1 Group 3: mRNA-1083 Lot C Experimental Treatment 1 Intervention

Participants will receive mRNA-1083 Lot C as a single injection on Day 1 in Part 1.

Group V: Part 1 Group 2: mRNA-1083 Lot B Experimental Treatment 1 Intervention

Participants will receive mRNA-1083 Lot B as a single injection on Day 1 in Part 1.

Group VI: Part 1 Group 1: mRNA-1083 Lot A Experimental Treatment 1 Intervention

Participants will receive mRNA-1083 Lot A as a single injection on Day 1 in Part 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

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 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 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]

A case of acute myocarditis was reported in a 44-year-old man who experienced chest pain four days after receiving the second dose of the mRNA-1273 SARS-CoV-2 vaccine, highlighting a potential rare adverse effect of this vaccine.

Despite the occurrence of myocarditis, the patient fully recovered within a month with supportive treatment, indicating that while this side effect can occur, it may be manageable and does not necessarily lead to long-term cardiac issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case report: acute myocarditis following the second dose of mRNA-1273 SARS-CoV-2 vaccine. Tailor, PD., Feighery, AM., El-Sabawi, B., 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 mRNA-1273 Moderna COVID-19 vaccine was found to have a safety profile in a real-world setting in Japan that is consistent with clinical trial data, indicating it is well-tolerated among participants.

In a survey of 301 respondents, 98% reported local and systemic adverse events following the second dose, with younger individuals (18-29 years) and females experiencing higher rates of adverse events after the first dose, although these differences diminished with subsequent doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-Time Survey of Vaccine Safety of the mRNA-1273 SARS-CoV-2 Vaccine in Workplace Vaccination at Keio University. Okumura, K., Hara, A., Inada, I., et al.[2022]

The TACTIC study found that while it is safe to administer the mRNA COVID-19 booster and the influenza vaccine concurrently, the immune response (measured by antibody levels) was lower compared to receiving the COVID-19 booster alone, indicating potential reduced protection against COVID-19.

In a trial involving 154 participants aged 60 and older, the concurrent administration did not meet the non-inferiority criteria for antibody response, suggesting that while side effects were mild and similar across groups, further research is needed to fully understand the implications of co-vaccination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Timing and sequence of vaccination against COVID-19 and influenza (TACTIC): a single-blind, placebo-controlled randomized clinical trial. Dulfer, EA., Geckin, B., Taks, EJM., et al.[2023]

Citations

1. nature.com nature.com/articles/s41541-025-01145-6

Comparing Moderna's mRNA-1083 and Pfizer's dual- ... Moderna has reported promising trial results for mRNA-1083, showing strong immune responses against both SARS-CoV-2 and influenza antigens with ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06097273

NCT06097273 | A Study of mRNA-1083 (SARS-CoV-2 and ... The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of mRNA-1083 as compared with active control, co-administered licensed ...

3. pulmonologyadvisor.com pulmonologyadvisor.com/news/multicomponent-vaccine-for-covid19-and-influenza-prevention/

Multicomponent Vaccine for COVID-19, Influenza Shows ... The multicomponent mRNA-1083 vaccine elicited noninferior immune responses in adult patients when compared with coadministered influenza and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12197711/

Development of an Influenza/COVID-19 Combination ... We have recently developed a bivalent COVID-19 mRNA vaccine that encodes two SARS-CoV-2 antigens: the spike (S) protein receptor binding domain ...

5. healio.com healio.com/news/infectious-disease/20250702/moderna-reports-positive-phase-3-data-for-mrna-seasonal-flu-vaccine

Moderna reports positive phase 3 data for mRNA seasonal ... According to results reported by Moderna, the relative vaccine efficacy (rVE) of mRNA-1010 was 26.6% (95% CI, 16.7%-35.4%) higher than the ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40332892/

Immunogenicity and Safety of Influenza and COVID-19 ... In this study, mRNA-1083 met noninferiority criteria and induced higher immune responses than recommended standard care influenza (standard and high dose) and ...

7. infectiousdiseaseadvisor.com infectiousdiseaseadvisor.com/news/multicomponent-vaccine-for-covid19-and-influenza-prevention/

Multicomponent Vaccine for COVID-19, Influenza Shows ... They aimed to determine the immunogenicity and safety of mRNA-1083 against seasonal influenza and COVID-19 in adults aged 50 years and older.

8. pulmonologyadvisor.com pulmonologyadvisor.com/news/moderna-withdraws-bla-for-flu-covid-19-combo-vaccine-candidate/

Moderna Withdraws BLA for Flu/COVID-19 Combo Vaccine ... Recently published findings showed mRNA-1083 was noninferior to standard influenza and COVID-19 vaccines and induced higher immune responses ...