mRNA-1283 Vaccine for COVID-19

Recruiting at 4 trial locations

Overseen By Moderna WeCare Team

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: ModernaTX, Inc.

Must not be taking: Immunosuppressants, Immunoglobulins

Disqualifiers: Recent COVID-19, Recent vaccines, 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: 1

Duration: 1 day

832 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new COVID-19 vaccine, mRNA-1283, to evaluate its effectiveness and safety in the current COVID-19 environment. The vaccine contains a virus variant to better match circulating strains. Individuals 65 or older, or those aged 12 to 64 with a risk factor for severe COVID-19, who haven't recently had COVID-19 or a vaccine, might be suitable participants. The goal is to ensure the vaccine provides strong protection and is safe for those at higher risk of severe illness. As a Phase 4 trial, this study involves an FDA-approved vaccine and aims to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on systemic immunosuppressants or certain immune-affecting therapies, you may need to stop them before joining the study. It's best to discuss your specific medications with the trial team.

What is the safety track record for the mRNA-1283 variant-containing formulation?

Research shows that the mRNA-1283 vaccine for COVID-19 is generally well tolerated and safer than the earlier mRNA-1273 version. Most participants experienced only mild side effects, such as sore arms or slight fatigue, while serious side effects were rare.

The vaccine targets key parts of the virus, potentially enhancing its effectiveness while minimizing side effects. As the vaccine is in Phase 4, it has already undergone testing on many individuals, supporting its safety. This phase evaluates safety in larger groups.

For those considering joining a trial with this vaccine, the safety data appears promising. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the mRNA-1283.251 variant-containing formulation because it represents the next step in mRNA technology specifically tailored for COVID-19. Unlike existing vaccines such as Pfizer-BioNTech's BNT162b2 and Moderna's original mRNA-1273, this formulation is designed to target newer variants of the virus, potentially offering more robust protection against emerging strains. This targeted approach could lead to better efficacy and adaptability as the virus evolves, providing a crucial tool in the ongoing fight against COVID-19.

What is the effectiveness track record for the mRNA-1283 COVID-19 vaccine?

Research has shown that the mRNA-1283 vaccine yields promising results. In studies, it provided strong protection against COVID-19 by enhancing the body's immune system. Compared to the original mRNA-1273 vaccine, the mRNA-1283 version improved the immune response and was well tolerated. This trial will specifically evaluate the mRNA-1283.251 variant-containing formulation, which targets key parts of the virus, potentially increasing its effectiveness. Overall, evidence supports its ability to enhance immunity against COVID-19 variants. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for individuals who want to participate in testing a new COVID-19 vaccine formulation targeting variants. Specific eligibility criteria are not provided, but typically participants should be healthy or have stable health conditions.

Inclusion Criteria

I am not pregnant, have used birth control, and will continue to do so during the study.

I understand and can follow the study's required visits and procedures.

I am 65 or older, or I am 12 to 64 with a risk factor for severe COVID-19.

Exclusion Criteria

Subprotocol 1: History of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 6 months prior to enrollment

Subprotocol 1: Acutely ill or febrile (temperature ≥38.0°Celsius/≥100.4°Fahrenheit) within 72 hours prior to or at the Screening Visit or Day 1. Participants meeting this criterion may be rescheduled within the Screening window and will retain their initially assigned participant number

Subprotocol 1: History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an intramuscular injection of a mRNA-1283 variant-containing formulation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• mRNA-1283 Variant-containing Formulation

Trial Overview The study is evaluating the immune response and safety of mRNA-1283, a variant-specific COVID-19 vaccine (mNEXSPIKE®), considering the current spread and mutation of the virus.

How Is the Trial Designed?

Group I: mRNA-1283.251 Variant-containing Formulation Experimental Treatment 1 Intervention

Participants will receive an intramuscular (IM) injection of a mRNA-1283.251 variant-containing formulation.

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. thelancet.com thelancet.com/journals/laninf/article/PIIS1473-3099(25)00236-1/fulltext

Efficacy, immunogenicity, and safety of a next-generation ... We evaluated the relative vaccine efficacy (rVE), immunogenicity, and safety of mRNA-1283 compared to the first-generation vaccine (mRNA-1273).

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07089706

NCT07089706 | A Study to Evaluate the Immunogenicity ... The purpose of this study is to evaluate the immunogenicity and safety of the recommended variant-containing formulations of mRNA-1283 COVID-19 vaccine ( ...

3. academic.oup.com academic.oup.com/jid/article/231/4/e754/7951371

Safety and Immunogenicity of SARS-CoV-2 Spike Receptor ... The mRNA-1283 vaccine encoding the RBD and NTD of the SARS-CoV-2 spike protein was well tolerated and had improved immunogenicity compared with mRNA-1273,

4. fda.gov fda.gov/media/189497/download?attachment

Moderna MNEXSPIKE (STN 125835/6) 2025-2026 Formula Descriptive relative vaccine efficacy (rVE) data from Study mRNA-1283-P301 Part 1 provides supportive evidence for MNEXSPIKE vaccine ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1473309925002361

Efficacy, immunogenicity, and safety of a next-generation ... mRNA-1283 is an investigational, next-generation COVID-19 vaccine that encodes only the immunodominant regions of the SARS-CoV-2 spike protein— ...