A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1073 (COVID-19/Influenza) Vaccine in Adults 18 to 75 Years Old

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

550 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new vaccine called mRNA-1073 in healthy people to see if it is safe and effective. The vaccine works by teaching the body to recognize and fight the virus using a small, harmless piece of it. mRNA vaccines have been proven to work efficiently, have high potency, and can be rapidly developed and deployed, which is critical for quick responses in the case of a pandemic.

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.

How is the drug mRNA-1010 different from other treatments?

The drug mRNA-1010 is unique because it uses messenger RNA (mRNA) technology, which instructs cells to produce proteins that help the immune system recognize and fight specific viruses. This approach is different from traditional vaccines that often use weakened or inactivated viruses to stimulate an immune response. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

Interventions

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

Participant Groups

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

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Phase 2 trial of sustained-release fampridine in chronic spinal cord injury. [2014]

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

Efficacy of a C1-C2 self-sustained natural apophyseal glide (SNAG) in the management of cervicogenic headache. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Influence of active versus placebo control on treatment responses in randomised controlled trials in rheumatoid arthritis. [2023]

4. United States 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. [2021]

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

Efficacy of cervical endplay assessment as an indicator for spinal manipulation. [2015]