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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, days 121 and 181

Awards & highlights

Study Summary

This trial will test the safety and effectiveness of 2 influenza vaccines against common flu strains.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, days 121 and 181

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, days 121 and 181

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, days 121 and 181 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline in Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay

Change from Baseline in Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutinin Inhibition (HAI) Assay

Number of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically Attended Adverse Events (MAAEs), and AEs Leading to Discontinuation

+3 more

Secondary outcome measures

Change from Baseline in GMFR of Anti-HA Antibodies at Days 121 and 181, as Measured by HAI Assay or MN Assay

Change from Baseline in GMT of Anti-HA Antibodies at Days 121 and 181, as Measured by HAI Assay or Microneutralization (MN) Assay

Side effects data

From 2022 Phase 1 & 2 trial • 885 Patients • NCT04956575

74%

Injection site pain

46%

Fatigue

42%

Headache

32%

Myalgia

26%

Injection site lymphadenopathy

24%

Arthralgia

18%

Chills

10%

COVID-19

Vomiting

Sinusitis

Urinary tract infection

Upper respiratory tract infection

Rhinovirus infection

Road traffic accident

Gastroenteritis

Muscle strain

Injection site erythema

Musculoskeletal chest pain

Hypertension

Oropharyngeal pain

100%

80%

60%

40%

20%

Study treatment Arm

Phase 2 Extension: mRNA-1010 6.25 ug

Phase 2 Extension: mRNA-1010 25 ug

Phase 1/2: mRNA-1010 200 ug

Phase 2 NH: mRNA-1010 100 ug

Phase 2 NH: mRNA-1010 25 ug

Phase 2 Extension: mRNA-1010 12.5 ug

Phase 2 NH: mRNA-1010 50 ug

Phase 1/2: mRNA-1010 50 ug

Phase 1/2: mRNA-1010 100 ug

Phase 2 NH: Afluria Quadrivalent 60 ug

Phase 2 Extension: Afluria Quadrivalent 60 ug

Phase 1/2: Placebo

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: 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: 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: 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 IV: 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 V: 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-1010

2022

Completed Phase 3

~31590

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 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.