What side effects are associated with this type of intervention?

Common side effects of flu shots, including mRNA-based quadrivalent influenza vaccines, typically include soreness at the injection site, mild fever, fatigue, and muscle aches. These side effects are generally mild and resolve on their own. Serious side effects are rare but can include allergic reactions. The safety profile of mRNA-based vaccines is expected to be similar to that of traditional flu vaccines.

What prior FDA approvals exist?

The FDA has approved various influenza vaccines, including quadrivalent formulations that protect against four different flu virus strains. Traditional flu vaccines include inactivated influenza vaccines (IIV) and live attenuated influenza vaccines (LAIV). Recently, mRNA technology has been explored for flu vaccines, similar to the mRNA-based COVID-19 vaccines. These mRNA vaccines instruct cells to produce antigens that elicit an immune response. While specific mRNA-based flu vaccines like the ones in the trial (MRT5421, MRT5424, and MRT5429) are still under investigation, the success of mRNA technology in COVID-19 vaccines suggests potential for future FDA approvals in this area.

What other types of research exist?

Promising novel alternatives to mRNA-based Quadrivalent Influenza Vaccines for flu shot patients in 2024 include high-dose trivalent vaccines, recombinant-hemagglutinin (rHA) quadrivalent vaccines, and adenovirus-based quadrivalent vaccines. These alternatives have shown favorable immune responses and effectiveness in studies.

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Virus Therapy

Flu Vaccine for Adults

Phase 1 & 2

Waitlist Available

Research Sponsored by Sanofi Pasteur, a Sanofi Company

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 throughout the study (approximately 12 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing new mRNA flu vaccines in adults aged 18 and older. The vaccines work by using genetic instructions to help the body recognize and fight the flu virus. The study aims to see if these new vaccines are safe and effective. The first mRNA vaccines against potentially pandemic avian H10N8 and H7N9 influenza viruses were evaluated for safety and effectiveness over a period of several years.

Who is the study for?

Adults aged 18 and older can join this study to test new flu vaccines. People with a history of severe allergic reactions to any vaccine ingredients or who are immunocompromised may not be eligible.

What is being tested?

The trial is testing the safety and immune response of three different mRNA flu vaccines against standard dose, high-dose, and recombinant flu vaccines given as a single shot in the muscle.

What are the potential side effects?

Possible side effects include pain at the injection site, fatigue, headache, muscle pain, chills, fever, nausea; these are common for most flu shots.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout the study (approximately 12 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~throughout the study (approximately 12 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the study (approximately 12 months) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

AESIs reported throughout the study

Geometric Mean Titer (GMT)

Geometric Mean of individual Titer Ratio (GMTR)

+10 more

Secondary study objectives

2-fold and 4-fold increase in neutralizing titers

Individual neutralizing antibodies titer ratio

Neutralizing Ab titers at D01 and D29

Awards & Highlights

No Placebo-Only Group

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

Trial Design

10Treatment groups

Experimental Treatment

Active Control

Group I: Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 4Experimental Treatment1 Intervention

participants will receive a single dose of QIV mRNA vaccine MRT5429

Group II: Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 3Experimental Treatment1 Intervention

participants will receive a single dose of QIV mRNA vaccine MRT5429

Group III: Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 2Experimental Treatment1 Intervention

participants will receive a single dose of QIV mRNA vaccine MRT5429

Group IV: Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 1Experimental Treatment1 Intervention

participants will receive a single dose of QIV mRNA vaccine MRT5429

Group V: Quadrivalent Influenza mRNA Vaccine MRT5424 Dose 2Experimental Treatment1 Intervention

participants will receive a single dose of QIV mRNA vaccine MRT5424

Group VI: Quadrivalent Influenza mRNA Vaccine MRT5424 Dose 1Experimental Treatment1 Intervention

participants will receive a single dose of QIV mRNA vaccine MRT5424

Group VII: Quadrivalent Influenza mRNA Vaccine MRT5421 Dose 1Experimental Treatment1 Intervention

participants will receive a single dose of QIV mRNA vaccine MRT5421

Group VIII: Quadrivalent Influenza HD VaccineActive Control1 Intervention

participants will receive a single dose of QIV -HD vaccine (for adults ≥ 65 years of age only)

Group IX: Quadrivalent Influenza SD VaccineActive Control1 Intervention

participants will receive a single dose of QIV-SD vaccine

Group X: Quadrivalent Influenza RIV4 VaccineActive Control1 Intervention

participants will receive a single dose of RIV4 vaccine

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

mRNA-based flu vaccines, such as the Quadrivalent Influenza Vaccine (QIV), work by using messenger RNA to instruct cells in the body to produce antigens that mimic the influenza virus. These antigens then trigger the immune system to mount a response, creating antibodies that can recognize and fight the actual virus if the person is exposed in the future. This mechanism is significant for flu shot patients because it allows for a rapid and robust immune response, potentially offering better protection against multiple strains of the flu virus included in the vaccine.

Effect of vibration associated with cryotherapy on vaccine-related pain and anxiety levels in adults: study protocol for a randomized clinical trial.