mRNA Vaccines for Flu and COVID-19

Recruiting at 17 trial locations

Overseen By Moderna Clinical Trials Support Center

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: ModernaTX, Inc.

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Acute illness, Drug abuse, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

1231 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new vaccine called mRNA-1083 in adults aged 18 to 79 years old. The vaccine uses a small piece of genetic material to help the body recognize and fight off the flu.

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 immunosuppressants, you may not be eligible to participate. It's best to discuss your specific medications with the trial team.

Is the mRNA-1283 vaccine safe for humans?

The mRNA-1283 vaccine was generally safe in adults, with no serious adverse events reported in a phase 1 trial. Some mild reactions were more frequent at higher doses, but overall, it was well-tolerated. ^{1 2 3 4 5}

How is the mRNA-1010 treatment for flu and COVID-19 different from other treatments?

The mRNA-1010 treatment is unique because it uses messenger RNA (mRNA) technology to instruct cells to produce proteins that trigger an immune response, unlike traditional vaccines that use inactivated viruses. This approach has shown higher immune responses for certain flu strains compared to standard vaccines and can be administered alongside COVID-19 mRNA vaccines without significant interference. ^{1 5 6 7 8}

What data supports the effectiveness of the drug mRNA-1273.222 in the clinical trial for mRNA Vaccines for Flu and COVID-19?

Research shows that the mRNA-1273 vaccine, which is similar to mRNA-1273.222, had a 94% effectiveness in preventing COVID-19 in high-risk adults after the second dose. This suggests that mRNA-1273.222 may also be effective in providing protection against COVID-19. ^{1 2 5 9 10}

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 65–79 who've completed their initial COVID-19 vaccine series at least 4 months ago and haven't had a flu shot in the last 5 months. Participants must be willing to attend up to 5 visits and take about 4 calls over roughly 7 months.

Inclusion Criteria

Would you be able and willing to participate in to up to 5 in-person visits and about 4 phone calls over a time period of up to 7 months?

Are you 65–79 years of age?

In general, do you consider yourself to be in good health?

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 injection of either mRNA-based vaccines or comparator vaccines on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, reactogenicity, and immunogenicity, with primary outcome measures assessed at Day 29

4 weeks

1 visit (in-person), additional monitoring as needed

Extended Follow-up

Participants are monitored for long-term immunogenicity and safety, with secondary outcome measures assessed at Day 181

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Fluarix
• Fluzone HD
• mRNA-1010
• mRNA-1010.4
• mRNA-1083.1
• mRNA-1083.2
• mRNA-1083.3
• mRNA-1273.222
• mRNA-1283.222

Trial Overview The study tests several mRNA-based vaccines against influenza and COVID-19, including new formulations like mRNA-1283.222, to find the best composition and dose for future larger trials.

How Is the Trial Designed?

Group I: Part 2: mRNA-1083 Composition 2 Dose D Experimental Treatment 1 Intervention

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

Group II: Part 2: mRNA-1083 Composition 2 Dose C Experimental Treatment 1 Intervention

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

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

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

Group VI: Part 2: 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 VII: Part 2: 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 VIII: Part 2: mRNA-1083 Composition 1 Dose A Experimental Treatment 1 Intervention

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

Group IX: Part 1 Cohort B7: mRNA-1083.3 Experimental Treatment 1 Intervention

Participants will receive single IM injection of mRNA-1083.3 on Day 1.

Group X: Part 1 Cohort B6: mRNA-1083.2 Dose C Experimental Treatment 1 Intervention

Participants will receive single IM injection of mRNA-1083.2 at Dose Level C on Day 1.

Group XI: Part 1 Cohort B5: mRNA-1083.2 Dose B Experimental Treatment 1 Intervention

Participants will receive single IM injection of mRNA-1083.2 at Dose Level B on Day 1.

Group XII: Part 1 Cohort B4: mRNA-1083.2 Dose A Experimental Treatment 1 Intervention

Participants will receive single IM injection of mRNA-1083.2 at Dose Level A on Day 1.

Group XIII: Part 1 Cohort B3: mRNA-1083.1 Dose C Experimental Treatment 1 Intervention

Participants will receive single IM injection of mRNA-1083.1 at Dose Level C on Day 1.

Group XIV: Part 1 Cohort B2: mRNA-1083.1 Dose B Experimental Treatment 1 Intervention

Participants will receive single IM injection of mRNA-1083.1 at Dose Level B on Day 1.

Group XV: Part 1 Cohort B1: mRNA-1083.1 Dose A Experimental Treatment 1 Intervention

Participants will receive single IM injection of mRNA-1083.1 at Dose Level A on Day 1.

Group XVI: Part 1 Cohort A7: mRNA-1083.3 Experimental Treatment 1 Intervention

Participants will receive single IM injection of mRNA-1083.3 on Day 1.

Group XVII: Part 1 Cohort A6: mRNA-1083.2 Dose C Experimental Treatment 1 Intervention

Participants will receive single IM injection of mRNA-1083.2 at Dose Level C on Day 1.

Group XVIII: Part 1 Cohort A5: mRNA-1083.2 Dose B Experimental Treatment 1 Intervention

Participants will receive single IM injection of mRNA-1083.2 at Dose Level B on Day 1.

Group XIX: Part 1 Cohort A4: mRNA-1083.2 Dose A Experimental Treatment 1 Intervention

Participants will receive single IM injection of mRNA-1083.2 at Dose Level A on Day 1.

Group XX: Part 1 Cohort A3: mRNA-1083.1 Dose C Experimental Treatment 1 Intervention

Participants will receive single IM injection of mRNA-1083.1 at Dose Level C on Day 1.

Group XXI: Part 1 Cohort A2: mRNA-1083.1 Dose B Experimental Treatment 1 Intervention

Participants will receive single intramuscular (IM) injection of mRNA-1083.1 at Dose Level B on Day 1.

Group XXII: Part 2: Influenza Vaccine 1 Active Control 1 Intervention

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

Group XXIII: Part 1 Cohort A12: Influenza Vaccine 1 Active Control 1 Intervention

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

Group XXIV: Part 1 Cohort A13: Influenza Vaccine 2 Active Control 1 Intervention

Participants will receive single IM injection of Influenza Vaccine 2 on Day 1.

Group XXV: Part 1 Cohort B8: Investigational Influenza Vaccine 1 Active Control 1 Intervention

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

Group XXVI: Part 1 Cohort A10: COVID-19 Vaccine 1 Active Control 1 Intervention

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

Group XXVII: Part 2: Investigational COVID-19 Vaccine 2 Active Control 1 Intervention

Participants will receive single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.

Group XXVIII: Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 Active Control 1 Intervention

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

Group XXIX: Part 1 Cohort A11: Investigational Influenza Vaccine 2 Active Control 1 Intervention

Participants will receive single IM injection of Investigational Influenza Vaccine 2 on Day 1.

Group XXX: Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 Active Control 1 Intervention

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

Group XXXI: Part 1 Cohort B10: COVID-19 Vaccine 1 Active Control 1 Intervention

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

Group XXXII: Part 1 Cohort B11: Investigational Influenza Vaccine 2 Active Control 1 Intervention

Participants will receive single IM injection of Investigational Influenza Vaccine 2 on Day 1.

Group XXXIII: Part 2: COVID-19 Vaccine 2 Active Control 1 Intervention

Participants will receive single IM injection of COVID-19 Vaccine 2 on Day 1.

Group XXXIV: Part 1 Cohort A8: Investigational Influenza Vaccine 1 Active Control 1 Intervention

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

Group XXXV: Part 2: Investigational Influenza Vaccine 1 Dose B Active Control 1 Intervention

Participants will receive single IM injection of Investigational Influenza Vaccine 1 at Dose Level B on Day 1.

Group XXXVI: Part 2: Investigational Influenza Vaccine 1 Dose A Active Control 1 Intervention

Participants will receive single IM injection of Investigational Influenza Vaccine 1 at Dose Level A on Day 1.

Group XXXVII: Part 1 Cohort B12: Influenza Vaccine 1 Active Control 1 Intervention

Participants will receive single IM injection of Influenza Vaccine 1 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]

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 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]

Citations

1. 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]

2. 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]

3. 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]

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

Efficacy of the mRNA-1273 SARS-CoV-2 Vaccine at Completion of Blinded Phase. [2023]

5. 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]

6. England pubmed.ncbi.nlm.nih.gov

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

7. 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]

8. 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]

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

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

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

The dawn of mRNA vaccines: The COVID-19 case. [2022]