600 Participants NeededMy employer runs this trial

mRNA COVID-19 Vaccines for COVID-19

Recruiting at 7 trial locations
MW
Overseen ByModerna WeCareTeam
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two different mRNA COVID-19 vaccines, mRNA-1283 and mRNA-1273, to evaluate their ability to boost the immune system and ensure safety in the current COVID-19 environment. Participants will receive one shot of either vaccine, aiding researchers in assessing effectiveness against new virus variants. Individuals over 65 or those 12 and older with risk factors for severe COVID-19 may be suitable for this study. This research aims to enhance vaccine options for those at higher risk of severe COVID-19 outcomes. As a Phase 4 trial, it involves FDA-approved vaccines, confirming their proven effectiveness while exploring additional benefits for more patients.

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 immunosuppressive treatment, you may need to stop, as it is not allowed within 180 days before the study or during participation.

What is the safety track record for these treatments?

Research has shown that both the mRNA-1273 and mRNA-1283 COVID-19 vaccines are generally safe. For mRNA-1273, studies have found common side effects such as pain at the injection site, headache, tiredness, and chills. These effects are usually mild and occur soon after vaccination. However, some reports have noted more serious side effects, like heart inflammation, mostly after the second dose.

For mRNA-1283, safety findings mirror those of mRNA-1273. Reports indicate that pain at the injection site and tiredness are the most common side effects, generally mild and self-resolving. So far, studies have not directly linked any serious side effects to mRNA-1283.

Overall, both vaccines are well-tolerated, with most side effects being mild and short-lived.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about mRNA-1273 and mRNA-1283 because they represent a new wave of COVID-19 vaccines using mRNA technology, which has been pivotal in the rapid development and deployment of vaccines. Unlike traditional vaccines that may use inactivated viruses or viral proteins, these vaccines introduce a small piece of mRNA that instructs cells to produce a harmless part of the virus, triggering an immune response. This mechanism allows for quicker adaptation to new variants, offering the potential for more effective protection against emerging strains. Additionally, mRNA-1283 aims to improve stability and ease of storage, addressing logistical challenges seen with earlier vaccines.

What evidence suggests that this trial's treatments could be effective for COVID-19?

Research has shown that the mRNA-1273 vaccine, one of the treatments in this trial, is highly effective, with a 94.1% success rate in preventing COVID-19 symptoms, including severe cases. Studies also confirm its effectiveness in real-world situations, with 87.4% effectiveness against COVID-19 infections. Meanwhile, early results for mRNA-1283, another treatment option in this trial, indicate it generates a strong immune response, particularly against variants like Omicron. Recent studies have shown promising results, with mRNA-1283 achieving its main goals. Both vaccines use mRNA technology, which helps the body learn to recognize and fight the virus effectively.678910

Are You a Good Fit for This Trial?

This trial is for people who are eligible to receive a COVID-19 vaccine and want to help test new versions designed for different variants. Participants should generally be healthy, but specific inclusion or exclusion details aren't provided here.

Inclusion Criteria

I am a woman who is not pregnant or breastfeeding.
I am 65 or older, or I am 12-64 with a risk factor for severe COVID-19.

Exclusion Criteria

I had a COVID-19 infection in the past 6 months.
History or conditions that could affect safety, endpoint assessment, immune response assessment, or adherence to study procedures as per Investigator's opinion
Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infections
See 6 more

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-1283 or mRNA-1273 on Day 1

1 day
1 visit (in-person)

Follow-up

Participants are monitored for immunogenicity and safety after receiving the vaccine

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • mRNA-1273
  • mRNA-1283

Trial Overview

The study compares two updated mRNA COVID-19 vaccines—mRNA-1273 and mRNA-1283—to see how well they trigger an immune response and how safe they are in the current environment.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: mRNA-1283 (Variant Formulation)Experimental Treatment1 Intervention
Group II: mRNA-1273 (Variant Formulation)Experimental Treatment1 Intervention

Find a Clinic Near You

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 profile image

Stéphane Bancel

ModernaTX, Inc.

Chief Executive Officer since 2011

MBA from Harvard Business School, MSc in Engineering from École Centrale Paris

Citations

Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine

The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease. Aside from transient local and systemic ...

Peer-reviewed report on Moderna COVID-19 vaccine ...

The investigational vaccine known as mRNA-1273 was 94.1% efficacious in preventing symptomatic coronavirus disease 2019 (COVID-19), ...

Real-world effectiveness of the mRNA-1273 vaccine against ...

These interim results from a prospective cohort study conducted confirm high effectiveness of 2 doses of mRNA-1273, with VE of 87·4% against COVID-19 infection, ...

Presentations and Publications

Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine This phase 3 clinical study of mRNA-1273 vaccine reports interim safety and primary ...

NCT04470427 | A Study to Evaluate Efficacy, Safety, and ...

The study is designed to primarily evaluate the efficacy, safety, and immunogenicity of mRNA-1273 to prevent COVID-19 for up to 2 years after the second dose of ...

Moderna COVID-19 Vaccine's Reactions and Adverse Events

Vaccine recipients reported higher rates of local reactions after dose 2 than dose 1. The frequency of local reactions was higher in the older ...

Safety evaluation of the COVID-19 mRNA-1273 (Moderna ...

The EUA contained a contraindication for use in those with known history of a severe allergic reaction to any vaccine component; however, no case of anaphylaxis ...

Safety and Tolerability Results | mNEXSPIKE® (COVID-19 ...

Postmarketing data from use of mRNA COVID-19 vaccines have demonstrated increased risks of myocarditis and pericarditis, with onset of symptoms typically in ...

Long-term adverse effects following COVID-19 vaccination

The most common long-term adverse effects reported after COVID-19 vaccination were chronic fatigue, impaired cognitive function, and menstrual ...

Real-life safety profile of mRNA vaccines for COVID-19

Most common adverse events following immunization for both mRNA vaccines were headache, fatigue, pyrexia, dizziness, nausea, pain, chills, and ...