What side effects are associated with this type of intervention?

Common treatments for influenza, particularly mRNA-based vaccines like mRNA-1010, are generally well tolerated but can have side effects. These side effects often include local reactions at the injection site (such as pain, redness, and swelling), systemic reactions like fever, chills, fatigue, headache, and muscle aches. Severe adverse events are rare but can include allergic reactions, including anaphylaxis. Most side effects are mild to moderate and resolve within a few days.

What prior FDA approvals exist?

The FDA has approved several treatments for influenza, including antiviral drugs like zanamivir and laninamivir. However, mRNA-based vaccines, which encode influenza antigens to elicit an immune response, represent a newer approach. While specific mRNA-based influenza vaccines like mRNA-1010 are still under study, the success of mRNA vaccines for COVID-19, such as mRNA-1273 (Moderna) and BNT162b2 (Pfizer-BioNTech), has paved the way for similar technologies to be explored for influenza prevention.

What other types of research exist?

One promising alternative to mRNA-1010 is the Multimeric-001 (M-001) vaccine. M-001 has demonstrated significant elevation of influenza-specific cellular-mediated immunity (CMI) and enhanced seroconversion towards multiple influenza strains. It has shown efficacy both as a standalone vaccine and as a primer to improve immune responses in elderly participants.

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Virus Therapy

mRNA-1010 Vaccine for Flu

Q: What is the mechanism of action of this treatment?

Common treatments for influenza include antiviral medications and vaccines. Antiviral medications, such as oseltamivir and zanamivir, inhibit the neuraminidase enzyme, preventing the release of new viral particles from infected cells, thereby limiting the spread of the virus within the body. Vaccines, including traditional inactivated vaccines and newer mRNA-based vaccines like mRNA-1010, work by introducing viral antigens to the immune system, prompting it to produce antibodies and memory cells that can recognize and fight the actual virus upon exposure. For influenza patients, these treatments are crucial as they can reduce the severity and duration of symptoms, prevent complications, and decrease the spread of the virus within the community.

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 older than 18 years old

Must not have

Has received systemic immunosuppressants (for glucocorticoids ≥ 10 mg/day of prednisone or equivalent) for > 14 days in total within 180 days before vaccination visit (D1) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study (including intra-articular steroid injections). Inhaled, nasal, and topical steroids are allowed.

Has received systemic immunoglobulins or long-acting biological therapies that may suppress or alter immune responses (for example, Infliximab®) or blood products within 90 days before the vaccination visit or plans to receive them during the study.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 57, 121, and 181

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new flu vaccine called mRNA-1010 to see if it is safe and effective for people who need flu shots. The new vaccine uses a small piece of genetic material to help the body recognize and fight the flu virus.

Who is the study for?

This trial is for healthy adults who can become pregnant but are not currently, using contraception or abstaining from pregnancy-causing activities. They must have a BMI of 18-<40 kg/m^2 (Part A only), no acute illness/fever before vaccination, and no history of severe allergies to mRNA or flu vaccines.

What is being tested?

The study tests the safety and immune response effectiveness of mRNA-1010 compared to other flu vaccines. Participants will be assessed on Day 29 for their body's defense against specific influenza strains.

What are the potential side effects?

Possible side effects include typical vaccine reactions like soreness at the injection site, fever, fatigue, headache, muscle pain. Severe allergic reactions are rare but possible in those with egg protein allergies.

Eligibility Criteria

Exclusion Criteria

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

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I have used strong immune system suppressants for more than 2 weeks in the last 6 months.

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I have not received immune-altering drugs or blood products in the last 90 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 57, 121, and 181

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 57, 121, and 181

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 57, 121, 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

Part C: Percentage of Participants with Seroresponse at Day 29, as Measured by RSV Neutralization Assay

Parts A, B, and C: Percentage of Participants with Seroresponse at Day 29, as Measured by HAI Assay

Secondary study objectives

Part C: Percentage of Participants with Seroresponse at Days 57, 121, and 181, as Measured by HAI Assay

Part C: Percentage of Participants with Seroresponse at Days 57, 121, and 181, as Measured by RSV Neutralization Assay

Awards & Highlights

No Placebo-Only Group

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

Trial Design

8Treatment groups

Experimental Treatment

Active Control

Group I: Parts A and B - Arm 5: mRNA-1010 (Age Group 65-80 years)Experimental Treatment1 Intervention

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

Group II: Parts A and B - Arm 1: mRNA-1010 (Age Group 18-50 years)Experimental Treatment1 Intervention

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

Group III: Part C - Arm 3: mRNA-1045 (Age Group 18-50 years)Experimental Treatment1 Intervention

Participants will receive a single dose of mRNA-1045 by IM injection on Day 1.

Group IV: Part C - Arm 2: mRNA-1010 and mRNA-1345 (Age Group 18-50 years)Experimental Treatment2 Interventions

Participants will receive one dose of mRNA-1010 at Day 1 followed by one dose of mRNA-1345 in the contralateral arm at Day 29.

Group V: Part C - Arm 1: mRNA-1010 and mRNA-1345 (Age Group 18-50 years)Experimental Treatment2 Interventions

Participants will receive one dose of mRNA-1010 concomitantly injected with one dose of mRNA-1345 in the contralateral arm at Day 1.

Group VI: Parts A and B - Arm 2: Egg-based Quadrivalent Influenza Vaccine (Age Group 18-50 years)Active Control1 Intervention

Participants will receive a single dose of egg-based quadrivalent influenza vaccine by IM injection on Day 1.

Group VII: Parts A and B - Arm 3: Adjuvanted Quadrivalent Influenza Vaccine (Age Group 65-80 years)Active Control1 Intervention

Participants will receive a single dose of adjuvanted quadrivalent influenza vaccine by IM injection on Day 1.

Group VIII: Parts A and B - Arm 4: Inactivated Influenza Vaccine (Age Group 65-80 years)Active Control1 Intervention

Participants will receive a single dose of inactivated influenza vaccine by IM injection on Day 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

mRNA-1345

2022

Completed Phase 3

~6360

mRNA-1010

2022

Completed Phase 3

~40020

0 / 2Eligibility 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

Common treatments for influenza include antiviral medications and vaccines. Antiviral medications, such as oseltamivir and zanamivir, inhibit the neuraminidase enzyme, preventing the release of new viral particles from infected cells, thereby limiting the spread of the virus within the body. Vaccines, including traditional inactivated vaccines and newer mRNA-based vaccines like mRNA-1010, work by introducing viral antigens to the immune system, prompting it to produce antibodies and memory cells that can recognize and fight the actual virus upon exposure. For influenza patients, these treatments are crucial as they can reduce the severity and duration of symptoms, prevent complications, and decrease the spread of the virus within the community.

Microarray Gene Expression Dataset Re-analysis Reveals Variability in Influenza Infection and Vaccination.Utility of influenza vaccination for oncology patients.