mRNA-1073 Vaccine for COVID-19/Influenza

No longer recruiting at 12 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: Immune-modifying drugs

Disqualifiers: Immunodeficiency, Anaphylaxis, Malignancy, others

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

Compensation: Varies

Number of Visits: 1

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-1073, which targets both COVID-19 and the flu. Researchers aim to determine its safety and effectiveness compared to other vaccines or the COVID-19 or flu vaccine alone. Individuals fully vaccinated against COVID-19, who received their last shot at least 120 days ago, might be suitable candidates. The trial involves receiving injections and monitoring reactions to assess immune system responses. As a Phase 1/Phase 2 trial, this research seeks to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking 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 immune-modifying treatments or systemic immunosuppressants, you may not be eligible to participate.

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

Research has shown that the mRNA-1010 and mRNA-1273 vaccines have not raised any serious safety concerns in past studies. For mRNA-1010, some individuals experienced mild reactions, such as sore arms, particularly at higher doses. No serious events or deaths related to the vaccine were reported. The mRNA-1273 vaccine, already used for COVID-19, has proven safe, with only minor reactions like temporary soreness or fever being common.

The current study on mRNA-1073 is in its early stages, focusing on both safety and effectiveness, so detailed safety information is still being collected. However, since mRNA-1073 combines parts of the other two vaccines, it is expected to have a similar safety profile. Generally, vaccines like these are well-tolerated, with most side effects being mild and temporary. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the mRNA-1073 vaccine because it uniquely combines protection against both COVID-19 and influenza in a single shot. This is different from current vaccines, which typically target just one virus at a time. The mRNA-1073 vaccine uses mRNA technology, which is known for its ability to be quickly adapted to new virus strains, potentially offering more responsive protection as viruses evolve. Additionally, the trial is testing different combinations of mRNA vaccines, such as mRNA-1010 and mRNA-1273, to optimize immune response and safety, which could lead to more effective vaccination strategies in the future.

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

Research shows that the mRNA-1073 vaccine, which combines protection against COVID-19 and the flu, appears promising. It uses mRNA technology to teach the body to recognize and fight these viruses. In this trial, participants will receive mRNA-1073 with a placebo to evaluate its effectiveness. Studies have shown that the mRNA-1010 vaccine creates strong immune responses against flu strains in adults. Participants in this trial will receive mRNA-1010 either alone with a placebo or combined with mRNA-1273. Meanwhile, the mRNA-1273 vaccine has demonstrated high effectiveness against COVID-19, with results showing up to 93.2% effectiveness. This trial will test mRNA-1273 both alone with a placebo and combined with mRNA-1010. Together, these vaccines might offer strong protection against both the flu and COVID-19. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

Inclusion Criteria

Participant has clinical screening laboratory values (total white blood cell count, hemoglobin, platelets, alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, alkaline phosphatase, and total bilirubin) > Grade 1.

Body mass index (BMI) of 18 kilograms per meter squared (kg/m^2) to 35 kg/m^2 (inclusive) at the Screening Visit.

Participants must have been fully vaccinated for COVID-19 primary series according to the locally authorized or approved regimen, and their last COVID-19 vaccine (primary series or booster) was ≥ 120 days prior to the randomization visit (or less per local guidance).

Exclusion Criteria

You have a skin condition that could interfere with the study's ability to evaluate skin reactions in certain areas.

Participant has a history of a diagnosis or condition that, in the judgment of the investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures. Clinically unstable is defined as a diagnosis or condition requiring significant changes in management or medication ≤ 60 days prior to Screening and includes ongoing workup of an undiagnosed illness that could lead to a new diagnosis or condition. Asymptomatic conditions and conditions with no evidence of end organ involvement (for example, mild hypertension, dyslipidemia) are not exclusionary, provided that they are being appropriately managed and are clinically stable (for example, unlikely to result in symptomatic illness within the time course of this study). Illnesses or conditions may be exclusionary, even if otherwise stable, due to therapies used to treat them (for example, immune-modifying treatments), at the discretion of the investigator.

You have been in close contact with someone who has been diagnosed with COVID-19 within the past 10 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the assigned vaccine regimen on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and immunogenicity, including adverse events and seroresponse

29 days

Multiple visits (in-person and virtual)

Extended Follow-up

Participants are monitored for long-term safety and adverse events

Up to 181 days

What Are the Treatments Tested in This Trial?

Interventions

• mRNA-1010
• mRNA-1073
• mRNA-1273
• Placebo

How Is the Trial Designed?

Group I: mRNA-1273 Plus Placebo Experimental Treatment 2 Interventions

Participants will receive 2 intramuscular (IM) injections, one in each arm, of mRNA-1273 plus placebo at the specified dose level on Day 1.

Group II: mRNA-1010 Plus mRNA-1273 Experimental Treatment 1 Intervention

Participants will receive 2 IM injections, one in each arm, of mRNA-1010 plus mRNA-1273 at the specified dose level on Day 1.

Group III: mRNA-1010 Plus Placebo Experimental Treatment 2 Interventions

Participants will receive 2 IM injections, one in each arm, of mRNA-1010 plus placebo at the specified dose level on Day 1.

Group IV: Dose C: mRNA-1073 Plus Placebo Experimental Treatment 2 Interventions

Participants will receive 2 IM injections, one in each arm, of mRNA-1073 plus placebo at the specified dose level on Day 1.

Group V: Dose B: mRNA-1073 Plus Placebo Experimental Treatment 2 Interventions

Participants will receive 2 IM injections, one in each arm, of mRNA-1073 plus placebo at the specified dose level on Day 1.

Group VI: Dose A: mRNA-1073 Plus Placebo Experimental Treatment 2 Interventions

Participants will receive 2 IM injections, one in each arm, of mRNA-1073 plus placebo at the specified dose level 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

The C1-C2 self-sustained natural apophyseal glide (SNAG) technique significantly improved the range of motion in the cervical spine by 15 degrees in participants with cervicogenic headaches, compared to only 5 degrees in the placebo group, indicating its effectiveness in addressing C1-C2 dysfunction.

Participants using the C1-C2 self-SNAG reported a substantial reduction in headache symptoms, with scores decreasing by 54% over 12 months, demonstrating its long-term efficacy in managing cervicogenic headaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a C1-C2 self-sustained natural apophyseal glide (SNAG) in the management of cervicogenic headache. Hall, T., Chan, HT., Christensen, L., et al.[2022]

In a study involving 100 patients undergoing lumbar spine fusion surgeries, batroxobin and its combination with tranexamic acid significantly reduced both intraoperative and postoperative blood loss compared to a placebo.

The mean intraoperative blood loss was lowest in the batroxobin group (268.32 mL) and the combination group (256.96 mL), indicating their effectiveness, while no significant differences were found in blood transfusion needs or complications like deep vein thrombosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety of Batroxobin, Tranexamic Acid and a Combination in Reduction of Blood Loss in Lumbar Spinal Fusion Surgery. Nagabhushan, RM., Shetty, AP., Dumpa, SR., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11970786/

An mRNA-based seasonal influenza vaccine in adults mRNA-1010 (50-µg) demonstrated an acceptable reactogenicity and safety profile among the >14,000 adult participants vaccinated in both trials.

2. cidrap.umn.edu cidrap.umn.edu/influenza-vaccines/moderna-announces-promising-efficacy-results-mrna-flu-vaccine-trial

Moderna announces promising efficacy results from mRNA ... In a press release, the company said its candidate flu vaccine, called mRNA 1010, showed superior results, with an rVE of 26.6% in the overall ...

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

A phase 3 randomized safety and immunogenicity trial of ... mRNA-1010 is an mRNA-based vaccine targeting seasonal influenza A and B strains. mRNA-1010 elicited strong immune responses in adults of all ages.

4. 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 ... Positive results​​ According to results reported by Moderna, the relative vaccine efficacy (rVE) of mRNA-1010 was 26.6% (95% CI, 16.7%-35.4%) ...

5. clinicaltrialsarena.com clinicaltrialsarena.com/news/moderna-mrna-flu-outperforms-current-standard-phase-iii/

Moderna's mRNA flu shot outperforms current standard at ... The pivotal study (NCT06602024) showed mRNA-1010 to be superior to the current vaccine with an rVE of 26.6%. Each flu strain within the vaccine ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11793046/

Safety and Immunogenicity of mRNA-1010, an Investigational ... No vaccine-related serious adverse events or deaths were reported. In parts 1 and 2, a single dose of mRNA-1010 (25–200 µg) elicited robust day 29 ...

7. nature.com nature.com/articles/s41467-023-39376-7

Safety and immunogenicity of a phase 1/2 randomized ... No safety concerns were identified; solicited adverse reactions were dose-dependent and more frequent after receipt of mRNA-1010 than the active ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05606965

NCT05606965 | A Study to Evaluate the Safety ... The main purpose of the study is to evaluate the safety, reactogenicity, and the humoral immunogenicity of mRNA-1010 and comparator influenza vaccines against ...

9. docs.publicnow.com docs.publicnow.com/viewDoc.aspx?filename=178244%5CEXT%5C7FA421479801DDD0860001CA37C34F7D57627F05_4F25D5BCC6C8241F8122B792867D5B831854005E.PDF

mRNA-1010, an mRNA-Based Influenza Vaccine, is Safe ... mRNA-1010, an mRNA-based influenza vaccine, is safe and efficacious in adults aged ≥50 years, including individuals at high risk for severe ...