What side effects are associated with this type of intervention?

The most common side effects of mRNA COVID-19 vaccines, such as those similar to mRNA-1283.222, include local reactions at the injection site (pain, redness, and swelling), systemic reactions (fever, fatigue, headache, muscle pain, chills, and joint pain), and, less frequently, severe allergic reactions (anaphylaxis). These side effects are generally short-lived and resolve within a few days. Serious adverse events are rare but can include myocarditis and pericarditis, particularly in younger males.

What prior FDA approvals exist?

The FDA has approved two mRNA vaccines for the treatment of COVID-19: BNT162b2 developed by Pfizer/BioNTech and mRNA-1273 developed by Moderna. These vaccines work by instructing cells to produce a protein that elicits an immune response against SARS-CoV-2. Clinical trials have shown high efficacy rates of 94-95% after two doses, with limited side effects and a low rate of adverse reactions. These approvals have paved the way for further development and evaluation of similar mRNA vaccines, such as mRNA-1283.222, which is currently being studied for its safety, reactogenicity, and immunogenicity.

What other types of research exist?

Promising alternatives to mRNA-1283.222 for COVID-19 patients in 2024 include the mRNA-1273 (Moderna) and BNT162b2 (Pfizer-BioNTech) vaccines. These vaccines have shown strong efficacy and safety profiles. Additionally, non-mRNA vaccines such as protein subunit vaccines (e.g., Novavax) and viral vector vaccines (e.g., Johnson & Johnson's Janssen) may also be considered, especially for their ability to elicit robust immune responses and adaptability to new variants.

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Vaccine

mRNA Vaccines Comparison for COVID-19 Prevention (NextCOVE Trial)

Phase 3

Waitlist Available

Research Sponsored by ModernaTX, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has previously received a primary series of an authorized/approved COVID-19 vaccine. For participants ≥18 years of age, at least 1 booster dose must have also been received. Proof of prior vaccination is required. A heterologous vaccine regimen is acceptable.

Must not have

Has received systemic immunoglobulins or blood products within 90 days prior to the Screening Visit or plans to receive during the study.

Has had close contact, as defined by the Centers for Disease Control and Prevention (CDC), with someone who had a SARS-CoV-2 infection in the past 14 days, or COVID-19 in the past 10 days.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 29, 91, 181, and 365

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new COVID-19 vaccine called mRNA-1283.222. It aims to see if this new vaccine is safe and effective. The vaccine works by using a small piece of genetic material to help the body recognize and fight the virus.

Who is the study for?

This trial is for people ≥12 years old who've had a full initial COVID-19 vaccination series, and if they're ≥18, at least one booster. They must show proof of vaccination, be able to follow the study plan, and not be pregnant or become pregnant during the study. People can't join if they've been exposed to COVID-19 recently, are sick or have a fever before starting the trial, have conditions that could risk their health in the study or affect results, plan to get other vaccines close to this trial's timeline, received certain treatments like blood products or immunosuppressants near the start of the trial.

What is being tested?

The study compares two mRNA vaccines: mRNA-1283.222 (new) versus mRNA-1273.222 (existing). It looks at how safe they are and how bodies react to them ('reactogenicity'), as well as comparing their effectiveness ('relative vaccine efficacy') and immune response ('immunogenicity').

What are the potential side effects?

While specific side effects aren't listed here, typical reactions may include pain at injection site, fatigue, headache, muscle pain, chills fever after getting vaccinated—commonly known as 'reactogenicity'. These usually last a short time.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have completed the initial COVID-19 vaccine series and, if over 18, received a booster.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have not received any blood products or immunoglobulins in the last 90 days and do not plan to receive any during the study.

Select...

I have been in close contact with someone who had COVID-19 recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 29, 91, 181, and 365

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 29, 91, 181, and 365

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 29, 91, 181, and 365 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1: SRR Difference of Ancestral SARS-CoV-2 D641G Between mRNA-1283.222 and mRNA-1273.222

Part 1: Seroresponse Rate (SRR) Difference of Omicron BA.4/5 Between mRNA-1283.222 and mRNA-1273.222

Parts 1 and 2: rVE of mRNA-1283 and mRNA-1273 (Variant Formulations) to Prevent the First Event of COVID-19

Secondary study objectives

Part 1: SRR Against Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Part 2: mRNA-1283.815Experimental Treatment1 Intervention

Participants will receive single IM injection of mRNA-1283.815 on Day 1.

Group II: Part 2: mRNA-1273.815Experimental Treatment1 Intervention

Participants will receive single IM injection of mRNA-1273.815 on Day 1.

Group III: Part 1: mRNA-1283.222Experimental Treatment1 Intervention

Participants will receive single intramuscular (IM) injection of mRNA-1283.222 on Day 1.

Group IV: Part 1: mRNA-1273.222Experimental Treatment1 Intervention

Participants will receive single IM injection of mRNA-1273.222 on Day 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

mRNA-1273.815

2021

Completed Phase 3

~5410

mRNA-1273.222

2021

Completed Phase 3

~6280

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

mRNA vaccines, such as the mRNA-1283.222, work by instructing cells to produce a protein that triggers an immune response. Specifically, these vaccines deliver synthetic mRNA encoding the spike protein of the SARS-CoV-2 virus into host cells. The cells then produce the spike protein, which is recognized as foreign by the immune system, prompting the production of antibodies and activating T-cells. This immune response prepares the body to fight off the actual virus if exposed in the future. This mechanism is crucial for COVID-19 patients as it provides a proactive defense, reducing the severity and spread of the disease. Other common treatments include antiviral drugs, which inhibit viral replication, and monoclonal antibodies, which neutralize the virus, but mRNA vaccines are particularly significant due to their role in preventing infection and severe outcomes.

COVID-19 mRNA Vaccine in Patients With Lymphoid Malignancy or Anti-CD20 Antibody Therapy: A Systematic Review and Meta-Analysis.The Side Effects and Adverse Clinical Cases Reported after COVID-19 Immunization.TLR4 as a therapeutic target for respiratory and neurological complications of SARS-CoV-2.