What is the mechanism of action of this treatment?

mRNA vaccines, such as the mRNA-1083, instruct cells to produce a protein that triggers an immune response, helping the body recognize and fight the virus. Monoclonal antibodies target the virus directly, while antiviral drugs like remdesivir inhibit viral replication. Steroids reduce inflammation caused by the immune response, and anticoagulants prevent blood clots, a common complication in severe COVID-19 cases. Understanding these mechanisms is crucial for COVID-19 patients as it helps tailor treatments to different stages and severities of the disease, improving outcomes.

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 the mRNA-1083 vaccine, include injection site pain, fatigue, headache, muscle pain, chills, fever, and nausea. These side effects are generally mild to moderate and resolve within a few days. Other treatments for COVID-19, such as monoclonal antibodies, may cause reactions like infusion-related reactions, rash, and diarrhea. Corticosteroids, used in severe cases, can lead to side effects like hyperglycemia, increased risk of infection, and gastrointestinal issues. Overall, the benefits of these treatments in preventing severe COVID-19 outcomes often outweigh the risks of side effects.

What prior FDA approvals exist?

The FDA has approved mRNA-based vaccines for the treatment of COVID-19, specifically the BNT162 vaccine developed by Pfizer/BioNTech and the mRNA-1273 vaccine developed by Moderna Inc. These vaccines use mRNA technology to instruct cells to produce the spike protein of the SARS-CoV-2 virus, which triggers an immune response. Both vaccines have shown around 95% clinical efficacy and have been granted emergency use authorization in the USA.

What other types of research exist?

Promising alternatives to the mRNA-1083 vaccine for COVID-19 patients in 2024 include other mRNA vaccines like mRNA-1273 (Spikevax), viral vector vaccines such as AstraZeneca's Vaxzevria and Johnson & Johnson's Janssen, protein subunit vaccines like Novavax, and treatments like monoclonal antibodies and antiviral drugs such as Paxlovid (nirmatrelvir/ritonavir).

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Virus Therapy

mRNA Vaccines for Flu and COVID-19

Phase 1 & 2

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

Are you 65–79 years of age?

In general, do you consider yourself to be in good health?

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (day 1) to day 29, and day 181

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new vaccine called mRNA-1083 in adults aged 18 to 79 years old. The vaccine uses a small piece of genetic material to help the body recognize and fight off the flu.

Who is the study for?

This trial is for healthy adults aged 65–79 who've completed their initial COVID-19 vaccine series at least 4 months ago and haven't had a flu shot in the last 5 months. Participants must be willing to attend up to 5 visits and take about 4 calls over roughly 7 months.

What is being tested?

The study tests several mRNA-based vaccines against influenza and COVID-19, including new formulations like mRNA-1283.222, to find the best composition and dose for future larger trials.

What are the potential side effects?

Potential side effects may include typical reactions seen with vaccinations such as soreness at injection site, fatigue, headache, muscle pain, chills or fever. Each individual's reaction can vary.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day 1) to day 29, and day 181

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (day 1) to day 29, and day 181

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) to day 29, and day 181 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 2: Influenza: Percentage of Participants with Seroconversion at Day 29, as Measured by HAI Assay

Part 2: SARS-CoV-2: Percentage of Participants with Seroresponse at Day 29, as Measured by PsVNA

Secondary study objectives

Part 1: Influenza: Percentage of Participants with Seroconversion, as Measured by HAI Assay

Part 1: SARS-CoV-2: Percentage of Participants with Seroresponse, as Measured by PsVNA

Part 2: Influenza: Percentage of Participants with Seroconversion at Day 181, as Measured by HAI Assay

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

37Treatment groups

Experimental Treatment

Active Control

Group I: Part 2: mRNA-1083 Composition 2 Dose DExperimental Treatment1 Intervention

Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level D on Day 1.

Group II: Part 2: mRNA-1083 Composition 2 Dose CExperimental Treatment1 Intervention

Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level C on Day 1.

Group III: Part 2: mRNA-1083 Composition 2 Dose BExperimental Treatment1 Intervention

Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level B on Day 1.

Group IV: Part 2: mRNA-1083 Composition 2 Dose AExperimental Treatment1 Intervention

Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level A on Day 1.

Group V: Part 2: mRNA-1083 Composition 1 Dose DExperimental Treatment1 Intervention

Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level D on Day 1.

Group VI: Part 2: mRNA-1083 Composition 1 Dose CExperimental Treatment1 Intervention

Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level C on Day 1.

Group VII: Part 2: mRNA-1083 Composition 1 Dose BExperimental Treatment1 Intervention

Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level B on Day 1.

Group VIII: Part 2: mRNA-1083 Composition 1 Dose AExperimental Treatment1 Intervention

Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level A on Day 1.

Group IX: Part 1 Cohort B7: mRNA-1083.3Experimental Treatment1 Intervention

Participants will receive single IM injection of mRNA-1083.3 on Day 1.

Group X: Part 1 Cohort B6: mRNA-1083.2 Dose CExperimental Treatment1 Intervention

Participants will receive single IM injection of mRNA-1083.2 at Dose Level C on Day 1.

Group XI: Part 1 Cohort B5: mRNA-1083.2 Dose BExperimental Treatment1 Intervention

Participants will receive single IM injection of mRNA-1083.2 at Dose Level B on Day 1.

Group XII: Part 1 Cohort B4: mRNA-1083.2 Dose AExperimental Treatment1 Intervention

Participants will receive single IM injection of mRNA-1083.2 at Dose Level A on Day 1.

Group XIII: Part 1 Cohort B3: mRNA-1083.1 Dose CExperimental Treatment1 Intervention

Participants will receive single IM injection of mRNA-1083.1 at Dose Level C on Day 1.

Group XIV: Part 1 Cohort B2: mRNA-1083.1 Dose BExperimental Treatment1 Intervention

Participants will receive single IM injection of mRNA-1083.1 at Dose Level B on Day 1.

Group XV: Part 1 Cohort B1: mRNA-1083.1 Dose AExperimental Treatment1 Intervention

Participants will receive single IM injection of mRNA-1083.1 at Dose Level A on Day 1.

Group XVI: Part 1 Cohort A7: mRNA-1083.3Experimental Treatment1 Intervention

Participants will receive single IM injection of mRNA-1083.3 on Day 1.

Group XVII: Part 1 Cohort A6: mRNA-1083.2 Dose CExperimental Treatment1 Intervention

Participants will receive single IM injection of mRNA-1083.2 at Dose Level C on Day 1.

Group XVIII: Part 1 Cohort A5: mRNA-1083.2 Dose BExperimental Treatment1 Intervention

Participants will receive single IM injection of mRNA-1083.2 at Dose Level B on Day 1.

Group XIX: Part 1 Cohort A4: mRNA-1083.2 Dose AExperimental Treatment1 Intervention

Participants will receive single IM injection of mRNA-1083.2 at Dose Level A on Day 1.

Group XX: Part 1 Cohort A3: mRNA-1083.1 Dose CExperimental Treatment1 Intervention

Participants will receive single IM injection of mRNA-1083.1 at Dose Level C on Day 1.

Group XXI: Part 1 Cohort A2: mRNA-1083.1 Dose BExperimental Treatment1 Intervention

Participants will receive single intramuscular (IM) injection of mRNA-1083.1 at Dose Level B on Day 1.

Group XXII: Part 2: Influenza Vaccine 1Active Control1 Intervention

Participants will receive single IM injection of Influenza Vaccine 1 on Day 1.

Group XXIII: Part 1 Cohort A12: Influenza Vaccine 1Active Control1 Intervention

Participants will receive single IM injection of Influenza Vaccine 1 on Day 1.

Group XXIV: Part 1 Cohort A13: Influenza Vaccine 2Active Control1 Intervention

Participants will receive single IM injection of Influenza Vaccine 2 on Day 1.

Group XXV: Part 1 Cohort B8: Investigational Influenza Vaccine 1Active Control1 Intervention

Participants will receive single IM injection of Investigational Influenza Vaccine 1 on Day 1.

Group XXVI: Part 1 Cohort A10: COVID-19 Vaccine 1Active Control1 Intervention

Participants will receive single IM injection of COVID-19 Vaccine 1 on Day 1.

Group XXVII: Part 2: Investigational COVID-19 Vaccine 2Active Control1 Intervention

Participants will receive single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.

Group XXVIII: Part 1 Cohort A9: Investigational COVID-19 Vaccine 1Active Control1 Intervention

Participants will receive single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.

Group XXIX: Part 1 Cohort A11: Investigational Influenza Vaccine 2Active Control1 Intervention

Participants will receive single IM injection of Investigational Influenza Vaccine 2 on Day 1.

Group XXX: Part 1 Cohort B9: Investigational COVID-19 Vaccine 1Active Control1 Intervention

Participants will receive single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.

Group XXXI: Part 1 Cohort B10: COVID-19 Vaccine 1Active Control1 Intervention

Participants will receive single IM injection of COVID-19 Vaccine 1 on Day 1.

Group XXXII: Part 1 Cohort B11: Investigational Influenza Vaccine 2Active Control1 Intervention

Participants will receive single IM injection of Investigational Influenza Vaccine 2 on Day 1.

Group XXXIII: Part 2: COVID-19 Vaccine 2Active Control1 Intervention

Participants will receive single IM injection of COVID-19 Vaccine 2 on Day 1.

Group XXXIV: Part 1 Cohort A8: Investigational Influenza Vaccine 1Active Control1 Intervention

Participants will receive single IM injection of Investigational Influenza Vaccine 1 on Day 1.

Group XXXV: Part 2: Investigational Influenza Vaccine 1 Dose BActive Control1 Intervention

Participants will receive single IM injection of Investigational Influenza Vaccine 1 at Dose Level B on Day 1.

Group XXXVI: Part 2: Investigational Influenza Vaccine 1 Dose AActive Control1 Intervention

Participants will receive single IM injection of Investigational Influenza Vaccine 1 at Dose Level A on Day 1.

Group XXXVII: Part 1 Cohort B12: Influenza Vaccine 1Active Control1 Intervention

Participants will receive single IM injection of Influenza Vaccine 1 on Day 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

mRNA-1083

2023

Completed Phase 3

~8080

0 / 6Eligibility 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-1083, instruct cells to produce a protein that triggers an immune response, helping the body recognize and fight the virus. Monoclonal antibodies target the virus directly, while antiviral drugs like remdesivir inhibit viral replication. Steroids reduce inflammation caused by the immune response, and anticoagulants prevent blood clots, a common complication in severe COVID-19 cases. Understanding these mechanisms is crucial for COVID-19 patients as it helps tailor treatments to different stages and severities of the disease, improving outcomes.

Current Therapeutics for COVID-19, What We Know about the Molecular Mechanism and Efficacy of Treatments for This Novel Virus.TLR4 as a therapeutic target for respiratory and neurological complications of SARS-CoV-2.An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment.