mRNA-1083 Vaccine for Influenza and COVID-19

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine, mRNA-1083, designed to protect against both flu and COVID-19. Researchers aim to evaluate its effectiveness, safety, and the body's response. Participants will receive different versions of the vaccine or a standard flu or COVID-19 vaccine for comparison. Individuals who have had at least two COVID-19 vaccines, with the last one over five months ago, and are generally healthy, might be suitable for this study. As a Phase 2 trial, this research measures the vaccine's effectiveness in an initial, smaller group, allowing participants to contribute to important early-stage findings.

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.

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

Research has shown that mRNA-1083 is generally safe, though some common side effects have been noted. Many participants reported mild issues such as pain at the injection site, fatigue, muscle aches, and headaches. Importantly, no severe reactions were reported. However, these side effects appeared slightly more frequently and were somewhat more intense compared to other vaccines. This treatment remains under study, and further information on its safety will emerge as research continues. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the mRNA-1083 vaccine because it combines protection against both influenza and COVID-19 in one shot, offering a convenient and potentially more efficient alternative to separate vaccinations. Unlike traditional flu and COVID-19 vaccines that use inactivated viruses or viral proteins, mRNA-1083 employs mRNA technology to instruct cells to produce proteins that trigger an immune response, potentially enhancing effectiveness. This innovative approach could streamline vaccination efforts, simplify logistics, and improve compliance, making it a promising advancement in the fight against these respiratory diseases.

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

Research has shown that the mRNA-1083 vaccine, which participants in this trial may receive, provides strong protection against both COVID-19 and the flu. Studies have found that this vaccine builds immunity more effectively than when flu and COVID-19 vaccines are administered separately. It specifically targets key flu strains (A/H1N1, A/H3N2, B/Victoria) and the virus that causes COVID-19, known as SARS-CoV-2. The effectiveness of mRNA-1083 matches or surpasses some existing vaccines. This promising evidence suggests the vaccine could effectively protect against both illnesses with just one shot. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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 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 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 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]

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]

Citations

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

Comparing Moderna's mRNA-1083 and Pfizer's dual- ... Moderna's mRNA-1083 showed superior immune responses, while Pfizer's mRNA-1020/1030 performed well but was slightly less effective against ...

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. infectiousdiseaseadvisor.com infectiousdiseaseadvisor.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/PMC12060023/

Immunogenicity and Safety of Influenza and COVID-19 ... Thus, mRNA-1083 induced higher immune responses against the 3 clinically relevant influenza strains (A/H1N1, A/H3N2, B/Victoria) and SARS-CoV-2 than licensed ...

5. kp-scalresearch.org kp-scalresearch.org/ResearchStudies/moderna-covid-flu-combination-vaccine-study/

Moderna COVID Flu Combination Vaccine Study This is a real-world study evaluating the effectiveness of mRNA-1083 (Moderna's influenza and COVID-19 combination vaccine) in preventing seasonal Influenza ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12103547/

Comparing Moderna's mRNA-1083 and Pfizer's dual-target ... The most reported adverse reactions were pain at the injection site, fatigue, muscle pain, and headache. No severe adverse reaction was reported ...

7. cidrap.umn.edu cidrap.umn.edu/covid-19/combo-flu-covid-vaccine-shows-good-immune-response-safety-older-adults

Combo flu-COVID vaccine shows good immune response, ... The adverse reactions were numerically higher in frequency and severity after mRNA-1083 vaccination than comparators in both age cohorts, the ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X25001446

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 ...

9. jamanetwork.com jamanetwork.com/journals/jama/article-abstract/2833668?resultClick=3

Immunogenicity and Safety of Influenza and COVID-19 ... Solicited adverse reactions were numerically higher in frequency and severity after mRNA-1083 vaccination than comparators in both age ...