mRNA Vaccine for COVID-19 and Flu

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

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

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

Research on similar mRNA vaccines, like mRNA-1273, shows they can create strong immune responses and protect against COVID-19. A combined mRNA vaccine for COVID-19 and flu has been shown to produce protective antibodies and immune responses in mice, suggesting potential effectiveness for mRNA-1083. ^{1 2 3 4 5}

Is the mRNA vaccine for COVID-19 and Flu generally safe for humans?

The mRNA vaccines, like those developed for COVID-19, have been shown to be generally safe in humans. Some people may experience mild side effects like chills, muscle aches, and fatigue, and there is a small risk of rare heart-related issues. Overall, these vaccines are well-tolerated and have a lower risk of serious side effects compared to traditional flu vaccines. ^{6 7 8 9 10}

How is the mRNA-1083 treatment different from other treatments for COVID-19 and flu?

The mRNA-1083 treatment is unique because it combines mRNA vaccines for both COVID-19 and influenza into a single shot, potentially offering protection against both viruses simultaneously. This combined approach could simplify vaccination schedules and improve convenience compared to receiving separate vaccines for each virus. ^{5 11 12 13 14}

What is the purpose of this trial?

The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity in relation to the product attributes of mRNA-1083 vaccine when administered as a single intramuscular (IM) injection in adults ≥50 to \<65 years of age.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

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]

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

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

3. 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]

4. 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]

5. England pubmed.ncbi.nlm.nih.gov

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

8. Switzerland 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. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Case report: acute myocarditis following the second dose of mRNA-1273 SARS-CoV-2 vaccine. [2023]

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

Phase I study of a non-S2P SARS-CoV-2 mRNA vaccine LVRNA009 in Chinese adults. [2023]

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

Concomitant administration of seasonal influenza and COVID-19 mRNA vaccines. [2023]

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

Timing and sequence of vaccination against COVID-19 and influenza (TACTIC): a single-blind, placebo-controlled randomized clinical trial. [2023]

13. England pubmed.ncbi.nlm.nih.gov

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

14. England pubmed.ncbi.nlm.nih.gov

Development of multivalent mRNA vaccine candidates for seasonal or pandemic influenza. [2023]