What side effects are associated with this type of intervention?

Common treatments for influenza that stimulate an immune response include vaccines and antiviral medications. Vaccines, such as the mRNA-1010 candidate, are generally well-tolerated but can cause side effects like injection site pain, fatigue, headache, muscle pain, and fever. Antiviral medications like oseltamivir and baloxavir can cause gastrointestinal side effects such as nausea, vomiting, and diarrhea. Rare but serious side effects include neuropsychiatric effects (e.g., delirium, hallucinations) and severe skin reactions (e.g., Stevens-Johnson syndrome). Overall, these treatments are effective but should be monitored for adverse reactions.

What prior FDA approvals exist?

The FDA has approved several treatments for influenza that stimulate an immune response. Notably, oseltamivir (Tamiflu) and zanamivir (Relenza) are antiviral medications that inhibit neuraminidase, an enzyme critical for viral replication. Additionally, baloxavir marboxil (Xofluza) is another antiviral that inhibits the cap-dependent endonuclease protein, essential for viral RNA transcription. These treatments, while not vaccines, help the immune system by reducing viral load and limiting the severity of the infection. The mRNA-1010 vaccine, currently under study, aims to stimulate an immune response by encoding proteins from the influenza virus, thereby preparing the immune system to recognize and combat the virus more effectively.

What other types of research exist?

Promising novel alternatives to the mRNA-1010 vaccine for influenza patients in 2024 include: 1) Universal influenza vaccines targeting conserved viral proteins to provide broader protection across different strains. 2) Recombinant protein vaccines, which use viral proteins produced in cell cultures. 3) Nanoparticle-based vaccines that enhance immune response and stability. 4) DNA vaccines, which use plasmid DNA to induce an immune response. These alternatives are in various stages of research and development and show potential for improved efficacy and broader protection.

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mRNA Vaccine

mRNA Vaccines for COVID-19

Phase 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

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 1 (baseline), 8, 29, 91, and 181

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing different versions of a new vaccine called mRNA-1010. It likely involves healthy volunteers or at-risk individuals. The vaccine uses mRNA to help the body recognize and fight the virus.

Who is the study for?

Healthy adults who can follow the study plan, have not had a flu shot or any vaccine within certain time frames before the trial, and show no severe allergies to mRNA vaccines. Women must test negative for pregnancy and use contraception. People with unstable health conditions or recent close contact with influenza cases are excluded.

What is being tested?

The trial is testing different versions of an mRNA-based flu vaccine called mRNA-1010 (including variations like mRNA-1010.4 and mRNA-1010.6) to see how safe they are, how people react to them, and how well they work at triggering an immune response.

What are the potential side effects?

Possible side effects may include typical reactions seen with vaccines such as pain at the injection site, fever, fatigue, headache, muscle pain, chills or joint pain. Severe allergic reactions are rare but could occur.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 1 (baseline), 8, 29, 91, and 181

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 1 (baseline), 8, 29, 91, and 181

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1 (baseline), 8, 29, 91, and 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

Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Study or Treatment Discontinuation

Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)

Number of Participants With Unsolicited Adverse Events (AEs)

Secondary study objectives

Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains

Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains

Percentage of Participants With Seroresponse for mRNA-1010, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains

Awards & Highlights

No Placebo-Only Group

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

Trial Design

6Treatment groups

Experimental Treatment

Group I: mRNA-1010.6 Dose CExperimental Treatment1 Intervention

Participants will receive a single dose of mRNA-1010.6 by IM injection on Day 1.

Group II: mRNA-1010.6 Dose BExperimental Treatment1 Intervention

Participants will receive a single dose of mRNA-1010.6 by IM injection on Day 1.

Group III: mRNA-1010.6 Dose AExperimental Treatment1 Intervention

Participants will receive a single dose of mRNA-1010.6 by IM injection on Day 1.

Group IV: mRNA-1010.4 Dose CExperimental Treatment1 Intervention

Participants will receive a single dose of mRNA-1010.4 by IM injection on Day 1.

Group V: mRNA-1010.4 Dose BExperimental Treatment1 Intervention

Participants will receive a single dose of mRNA-1010.4 by IM injection on Day 1.

Group VI: mRNA-1010 Dose CExperimental Treatment1 Intervention

Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

mRNA-1010.6

2023

Completed Phase 2

~270

mRNA-1010

2022

Completed Phase 3

~40020

mRNA-1010.4

2023

Completed Phase 2

~270

Do I qualify?Apply below to find out

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

Common treatments for influenza include antiviral drugs and vaccines. Antiviral drugs, such as neuraminidase inhibitors (e.g., zanamivir and laninamivir), work by blocking the function of the viral neuraminidase protein, preventing the virus from spreading within the respiratory tract. Vaccines, including the mRNA-1010 vaccine, stimulate the immune system to recognize and combat the influenza virus. These vaccines introduce viral components that prompt the body to produce antibodies, providing immunity against future infections. This immune response is crucial for influenza patients as it helps reduce the severity and duration of the illness, prevents complications, and decreases the spread of the virus within the community.

A Comparative and Comprehensive Review of Antibody Applications in the Treatment of Lung Disease.Understanding Childhood Neuroimmune Diseases of the Central Nervous System.The impact of currently licensed therapies on viral and immune responses in chronic hepatitis B: Considerations for future novel therapeutics.