mRNA-1273.712 Vaccine for Healthy Subjects

No longer recruiting at 24 trial locations

Overseen By Moderna Clinical Trials Support Center

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: ModernaTX, Inc.

Must not be taking: Immunosuppressants, Immunoglobulins, others

Disqualifiers: Myocarditis, Pericarditis, Diabetes, 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

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine, mRNA-1273.712, to assess its impact on heart health by measuring cardiac troponin I (cTnI), a protein indicating heart function. Participants will receive the vaccine and a placebo (a harmless substance resembling the vaccine) at different times for comparison. Individuals who are generally healthy and have not experienced COVID-19 or heart-related issues in recent months may be suitable for this trial. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective vaccine benefits a broader range of patients.

Do I need to stop taking my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are on systemic immunosuppressants or immune-modifying drugs, you may not be eligible if you've used them for more than 14 days in the past 6 months or plan to use them during the study.

What is the safety track record for the mRNA-1273.712 vaccine?

Research has shown that the mRNA-1273.712 vaccine is generally safe for people. Studies indicate that common side effects are mild and resolve quickly, including sore arms, fatigue, and headaches. Serious side effects are rare. One study found that this vaccine helps the body build a strong defense against viruses. Multiple studies support the absence of major safety concerns, so the vaccine is considered well-tolerated overall. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the mRNA-1273.712 vaccine because it represents a new frontier in vaccine technology, leveraging mRNA to instruct cells in producing a part of the virus, potentially enhancing immune response. Unlike traditional vaccines, which often use inactivated viruses or protein subunits, mRNA vaccines can be developed and produced rapidly, offering a quicker response to emerging variants. Moreover, the mRNA-1273.712 vaccine's adaptability might allow for more precise targeting of specific virus strains, which could lead to improved protection and flexibility in managing viral outbreaks.

What evidence suggests that the mRNA-1273.712 vaccine could be effective for healthy subjects?

Research has shown that mRNA-1273.712 effectively combats various virus strains in earlier studies. In this trial, participants will receive either mRNA-1273.712 followed by a placebo or a placebo followed by mRNA-1273.712. The mRNA-1273 vaccine series, including mRNA-1273.712, has proven effective in preventing COVID-19, even against new variants. Previous data confirms its safety and ability to strengthen the immune system. The vaccine teaches the body to fight the virus before exposure. Given its history, mRNA-1273.712 is expected to effectively trigger a protective immune response. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy individuals aged 12 to 30 years. The specific eligibility criteria are not provided, but typically participants must meet certain health standards and cannot have conditions that would interfere with the study or pose a risk.

Inclusion Criteria

Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF)

Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

I understand and can follow the study's requirements.

Exclusion Criteria

History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic or any components of an mRNA vaccine or therapeutic

Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the Investigator's judgment

I have had Guillain-Barré syndrome in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either mRNA-1273.712 or placebo, followed by crossover to the other treatment after 28 days

8 weeks

2 visits (in-person)

Follow-up

Participants are monitored for cardiac troponin I (cTnI) levels after receiving the vaccine or placebo

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• mRNA-1273.712

Trial Overview The study is testing whether there's a change in cardiac troponin I levels after receiving either the mRNA-1273.712 vaccine or a placebo. Cardiac troponin I is an indicator of heart muscle injury.

How Is the Trial Designed?

Group I: Sequence 2: Placebo then mRNA-1273.712 Experimental Treatment 2 Interventions

Participants will receive placebo followed by mRNA-1273.712 28 days later.

Group II: Sequence 1: mRNA-1273.712 then Placebo Experimental Treatment 2 Interventions

Participants will receive mRNA-1273.712 followed by placebo 28 days later.

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

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X25002580

mRNA-1273 vaccines adapted to JN.1 or KP.2 elicit cross- ... JN.1- and KP.2-matched mRNA-1273 vaccines neutralized matched strains in mice. These vaccines effectively cross-neutralized JN.1 subvariants KP.3, LA.2, and ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39209823/

Long-term safety and effectiveness of mRNA-1273 vaccine in ... Primary vaccination and boosting with mRNA-1273 demonstrated acceptable safety, effectiveness and immunogenicity against COVID-19, including emergent variants.

3. medrxiv.org medrxiv.org/content/10.1101/2025.09.26.25336704v1.full-text

Modeling the Anticipated Public Health Benefits of the Next ... The relative vaccine efficacy (rVE) of mRNA-1283 versus mRNA-1273 was 9.3% (99.4 % CI --6.6–22.8%) for COVID-19 symptomatic infection in the ...

4. fda.gov fda.gov/media/167306/download

Emergency Use Authorization (EUA) for an Unapproved ... It is further reasonable to expect that Spikevax (COVID-19 Vaccine, mRNA). (2024-2025 Formula) may be effective in individuals with certain ...

5. biorxiv.org biorxiv.org/content/10.1101/2024.12.24.629478v1.full.pdf

1 mRNA-1273 vaccines adapted to JN.1 or KP.2 elicit cross ... effectiveness of previously authorized XBB.1.5-adapted mRNA vaccines against infection, ... mRNA-1273.712 vaccine contained a single mRNA encoding ...

6. catalogues.ema.europa.eu catalogues.ema.europa.eu/node/4614/administrative-details

Post-marketing safety of the Moderna COVID-19 vaccine ... This retrospective US cohort study will actively monitor safety outcomes following administration of mRNA-1273.712 targeting the SARS-CoV-2 KP.

7. medrxiv.org medrxiv.org/content/10.1101/2025.05.02.25325954v1.full-text

and KP.2-Encoding mRNA COVID-19 Vaccines Against JN ... This ongoing, open-label, phase 3b/4 study evaluated the safety and immunogenicity of mRNA-1273.167 and mRNA-1273.712 against vaccine-matched variants and JN.1 ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37133747/

Safety outcomes associated with the moderna COVID-19 ... The transient nature of commonly observed AEs and the rare occurrence of severe events within mRNA-1273 recipients show no significant safety concerns which ...