mRNA Vaccines for COVID-19

Recruiting at 148 trial locations

Overseen By Moderna WeCare Team

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: ModernaTX, Inc.

Must not be taking: Corticosteroids, Immunosuppressives

Disqualifiers: Recent COVID-19, Acutely ill, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

30000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two different mRNA vaccines, mRNA-1283 and mRNA-1273, to evaluate their efficacy and safety. The focus is on healthy adults aged 50 to 64 who do not have conditions increasing their risk for severe COVID-19. Participants will receive a single shot of either one of the vaccines or a placebo (a shot without the active vaccine). Ideal participants have not recently had COVID-19 and have not received a COVID-19 vaccine in the last three months. As a Phase 4 trial, this research involves FDA-approved vaccines and aims to understand how they benefit 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 corticosteroids or systemic immunosuppressive treatments, you may need to stop them before joining the study.

What is the safety track record for these treatments?

Studies have shown that the COVID-19 vaccine mRNA-1273 is generally safe for most people. Most reactions, such as soreness at the injection site or a mild fever, are usually mild and resolve within a few days. However, some rare cases of heart inflammation, known as myocarditis, have been reported, particularly in younger males.

Research indicates that mRNA-1283 is also well tolerated. Common side effects include pain at the injection site, fatigue, and headaches, similar to those of mRNA-1273. Both vaccines have undergone extensive testing in many trials, providing reliable safety information. Consulting a healthcare provider about any concerns before joining a trial is always advisable. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about mRNA-1283 and mRNA-1273 for COVID-19 because these vaccines use a cutting-edge mRNA technology that is different from traditional vaccines. Unlike older vaccines that often use a weakened or inactive form of the virus to stimulate an immune response, mRNA vaccines work by instructing cells to produce a protein that triggers immunity, offering a faster and more flexible approach to combatting virus variants. This enables rapid updates to the vaccine design, which is crucial for addressing emerging variants of COVID-19. Additionally, the mRNA-1283 formulation is being explored for its potential to maintain stability at standard refrigerator temperatures, which could simplify distribution and storage compared to some existing mRNA vaccines.

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

Studies have shown that the mRNA-1273 vaccine, which participants in this trial may receive, effectively prevents COVID-19, with a 94.1% success rate. It also protects against severe cases of the illness. Research suggests that mRNA-1283, another treatment option in this trial, might trigger even stronger immune responses. Early findings indicate that mRNA-1283 could be as effective, or possibly more effective, than mRNA-1273. Both vaccines in this trial aim to prevent illness, particularly the more serious effects of the virus. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This clinical trial is for adults aged 50 to 64 who are not at high risk for severe COVID-19. Participants will be testing two variant formulations of mRNA vaccines, aiming to see how well they work and their safety profile.

Inclusion Criteria

I am healthy with no conditions that increase my COVID-19 risks, confirmed by medical tests.

Exclusion Criteria

Receipt of any of the following: COVID-19 vaccine within 3 months prior to enrollment, Any licensed non COVID-19 vaccine within 28 days before or planned receipt within 28 days after the study intervention, except an influenza vaccine, which may be given 14 days before or after receipt of the study intervention, Corticosteroids at ≥10 milligrams (mg)/day of prednisone or equivalent for >14 days in total within 90 days prior to Day 1 or is anticipating the need for corticosteroids at any time during the study, Systemic immunosuppressive treatment within 180 days prior to the Screening or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study

Has donated ≥450 mL of blood products within 28 days prior to the Screening Visit or plans to donate blood products within 28 days post study injection

Has participated in an investigational clinical study within 28 days prior to the Screening Visit based on the medical history interview or plans to do so while participating in this study

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-1273, mRNA-1283, or placebo on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

26 weeks

Multiple visits (in-person and/or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• mRNA-1273
• mRNA-1283

Trial Overview

The study is comparing the effectiveness and safety of two mRNA vaccines: mRNA-1283 and mRNA-1273. Some participants will receive a placebo instead. The goal is to determine if these vaccines can prevent COVID-19 in the specified age group without high-risk conditions.

How Is the Trial Designed?

Group I: mRNA-1283 (Variant Formulation) Experimental Treatment 1 Intervention

Participants will receive a single IM injection of mRNA-1283 on Day 1.

Group II: mRNA-1273 (Variant Formulation) Experimental Treatment 1 Intervention

Participants will receive a single intramuscular (IM) injection of mRNA-1273 on Day 1.

Group III: Placebo Placebo Group 1 Intervention

Participants will receive a single IM injection of placebo 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

Citations

1.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa2035389

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 ...

2.

cdc.gov

cdc.gov/acip/grade/covid-19-moderna-vaccine.html

Moderna COVID-19 Vaccine | ACIP

The Moderna COVID-19 vaccine reduced symptomatic laboratory-confirmed COVID-19 when compared to no COVID-19 vaccination (vaccine efficacy: 94.1 ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8862159/

A comprehensive review of SARS-CoV-2 vaccines: Pfizer ...

Efficacy. The Moderna mRNA-1273 vaccine is 94.1% effective at protecting against symptomatic COVID-19 after administration of the second dose. The vaccine's ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2667193X21001307

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

Phase 3 trials found mRNA-1273 was highly effective in preventing COVID-19. We conducted a prospective cohort study at Kaiser Permanente Southern California ...

5.

yalemedicine.org

yalemedicine.org/news/covid-19-vaccine-comparison

Comparing the COVID-19 Vaccines: How Are They Different?

Moderna's initial Phase 3 clinical data in December 2020 was similar to Pfizer-BioNTech's—it showed about 95% efficacy for prevention of COVID.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9206826/

Safety and Adverse Events Related to COVID-19 mRNA ...

Cardiac complications were the most commonly reported severe adverse events. It appeared that systemic adverse reactions are more common after the second dose ...

7.

cdc.gov

cdc.gov/covid/hcp/vaccine-considerations/safety-considerations.html

Safety Considerations for COVID-19 Vaccines

In COVID-19 vaccine clinical trials, most local and systemic post-vaccination reactions were mild to moderate and resolved in 1–3 days.

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S0264410X24001270

COVID-19 vaccines and adverse events of special interest

This study aimed to evaluate the risk of adverse events of special interest (AESI) following COVID-19 vaccination from 10 sites across eight countries.

9.

fda.gov

fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-approves-required-updated-warning-labeling-mrna-covid-19-vaccines-regarding-myocarditis-and

FDA Approves Required Updated Warning in Labeling of ...

The observed risk of myocarditis and pericarditis following vaccination with mRNA COVID-19 vaccines has been highest in males 12 through 24 years of age.

10.

nbcnews.com

nbcnews.com/health/health-news/fda-chief-biden-administration-covid-vaccine-heart-risk-data-rcna247440

FDA chief says Biden administration withheld data on heart ...

Myocarditis is a known — but small — side effect risk of the mRNA Covid vaccines from Pfizer and Moderna, information that federal agencies ...