What is the mechanism of action of this treatment?

The mRNA-based vaccines, such as GSK4382276A, work by using messenger RNA to instruct cells to produce a viral protein, which then triggers an immune response without causing disease. This prepares the immune system to recognize and combat the actual influenza virus. Antiviral medications like oseltamivir inhibit the neuraminidase enzyme, which is essential for the virus to spread from infected cells to healthy ones. These treatments are important for flu patients as they help prevent infection, reduce symptom severity, and shorten the duration of illness.

What side effects are associated with this type of intervention?

Common treatments for influenza include oseltamivir, baloxavir, and zanamivir. Oseltamivir can cause gastrointestinal symptoms such as nausea and vomiting, and has been associated with neuropsychiatric events, particularly in children. Baloxavir is generally well tolerated but can cause diarrhea and vomiting, with rare hypersensitivity reactions. Zanamivir, administered by inhalation, may cause bronchospasm, especially in patients with respiratory conditions. Neuraminidase inhibitors, in general, have modest effectiveness and can induce gastrointestinal side effects.

What prior FDA approvals exist?

The FDA has approved several antiviral drugs for the treatment of influenza, including oseltamivir, zanamivir, peramivir, and baloxavir. These drugs help reduce the duration and severity of flu symptoms. In terms of vaccines, the FDA has approved a quadrivalent recombinant HA influenza vaccine for individuals aged 18 and older, which uses recombinant DNA technology. Additionally, plant-based vaccines have been explored, showing promise in clinical trials. These recombinant and plant-based vaccines are somewhat similar to the mRNA-based multivalent seasonal influenza vaccine (GSK4382276A) being studied, as they represent advanced approaches to flu prevention.

What other types of research exist?

Promising alternatives to GSK4382276A for flu patients in 2024 include quadrivalent inactivated influenza vaccines, which provide broader protection by covering four strains of the virus, and trivalent inactivated influenza vaccines, which have demonstrated good immunogenicity and safety. Additionally, other mRNA-based influenza vaccines under development may offer novel options.

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Cancer Vaccine

mRNA Flu Vaccine for Influenza

Phase 1 & 2

Waitlist Available

Research Sponsored by GlaxoSmithKline

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

Any history of dementia or any medical condition that moderately or severely impairs cognition

Participants with extensive tattoos covering deltoid region on both arms that would preclude the assessment of local reactogenicity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from day 1 (pre-dose) to day 8 (post-dose) and/or day 29 (post-dose)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new mRNA-based flu vaccine in healthy younger and older adults. The vaccine uses genetic instructions to help the immune system recognize and fight the flu.

Who is the study for?

Healthy adults or those with stable chronic conditions, aged 18-50 in Phase 1 and 18-85 in Phase 2. Participants must have a BMI of >=18 and <=35 kg/m^2, agree to contraception if applicable, and not plan pregnancy soon after the trial. Exclusions include recent blood product receipt, influenza vaccination within past six months, other clinical trials participation, certain neurological disorders like Guillain-Barré syndrome, myocarditis/pericarditis history within ten years (including post-mRNA COVID-19 vaccine), dementia or severe cognitive impairment.

What is being tested?

The study is testing GSK's mRNA-based multivalent seasonal flu vaccine candidates for safety and immune response in two age groups. It involves comparing the new vaccines against controls that may be placebos or standard treatments to determine their effectiveness.

What are the potential side effects?

Potential side effects could include typical reactions at the injection site such as pain or swelling, general symptoms like fever or fatigue, allergic responses to components of the vaccine (e.g., polyethylene glycol), muscle aches, headaches and possibly more serious events related to immune system activation.

Eligibility Criteria

Exclusion Criteria

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

Select...

I have a condition that affects my thinking or memory.

Select...

I don't have extensive tattoos on both arms that would affect skin assessments.

Select...

I am bedridden.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day 1 (pre-dose) to day 8 (post-dose) and/or day 29 (post-dose)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from day 1 (pre-dose) to day 8 (post-dose) and/or day 29 (post-dose)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 (pre-dose) to day 8 (post-dose) and/or day 29 (post-dose) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Geometric mean increase (GMI) of antigen 1 antibody titer

Percentage of participants reporting a shift from a non-clinically significant laboratory value on Day 1 (pre-dose) to a clinically significant abnormal laboratory value on Day 8 (post-dose) and/or Day 29 (post-dose) for hematology and clinical chemistry

Percentage of participants reporting adverse events of special interest (AESIs)

+5 more

Secondary study objectives

GMI of antigen 1 antibody titer

GMI of antigen 2 antibody titer

Awards & Highlights

No Placebo-Only Group

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

Trial Design

21Treatment groups

Experimental Treatment

Active Control

Group I: Flu mRNA_Ph2_3_YA GroupExperimental Treatment1 Intervention

Eligible YA participants receive single dose of Flu mRNA (GSK4382276A) study intervention formulation 3 administered in Phase 2, at Day 1.

Group II: Flu mRNA_Ph2_3_OA GroupExperimental Treatment1 Intervention

Eligible OA participants receive single dose of Flu mRNA (GSK4382276A) study intervention formulation 6 administered in Phase 2, at Day 1.

Group III: Flu mRNA_Ph2_2_YA GroupExperimental Treatment1 Intervention

Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 2 administered in Phase 2, at Day 1.

Group IV: Flu mRNA_Ph2_2_OA GroupExperimental Treatment1 Intervention

Eligible OA participants receive single dose of Flu mRNA (GSK4382276A) study intervention formulation 5 administered in Phase 2, at Day 1.

Group V: Flu mRNA_Ph2_1_YA GroupExperimental Treatment1 Intervention

Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 1 administered in Phase 2, at Day 1.

Group VI: Flu mRNA_Ph2_1_OA GroupExperimental Treatment1 Intervention

Eligible OA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 4 administered in Phase 2, at Day 1.

Group VII: Flu mRNA_1_9 GroupExperimental Treatment1 Intervention

Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 9 administered in Phase 1, at Day 1.

Group VIII: Flu mRNA_1_8 GroupExperimental Treatment1 Intervention

Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 8 administered in Phase 1, at Day 1.

Group IX: Flu mRNA_1_7 GroupExperimental Treatment1 Intervention

Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 7 administered in Phase 1, at Day 1.

Group X: Flu mRNA_1_6 GroupExperimental Treatment1 Intervention

Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 6 administered in Phase 1, at Day 1.

Group XI: Flu mRNA_1_5 GroupExperimental Treatment1 Intervention

Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 5 administered in Phase 1, at Day 1.

Group XII: Flu mRNA_1_4 GroupExperimental Treatment1 Intervention

Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 4 administered in Phase 1, at Day 1.

Group XIII: Flu mRNA_1_3 GroupExperimental Treatment1 Intervention

Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 3 administered in Phase 1, at Day 1.

Group XIV: Flu mRNA_1_2 GroupExperimental Treatment1 Intervention

Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 2 administered in Phase 1, at Day 1.

Group XV: Flu mRNA_1_12 GroupExperimental Treatment1 Intervention

Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 12 administered in Phase 1, at Day 1.

Group XVI: Flu mRNA_1_11 GroupExperimental Treatment1 Intervention

Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 11 administered in Phase 1, at Day 1.

Group XVII: Flu mRNA_1_10 GroupExperimental Treatment1 Intervention

Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 10 administered in Phase 1, at Day 1.

Group XVIII: Flu mRNA_1_1 GroupExperimental Treatment1 Intervention

Eligible Younger Adults (YA) participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 1 administered in Phase 1, at Day 1.

Group XIX: Control_Ph2_OA GroupActive Control1 Intervention

Eligible OA participants receive a single dose of Control 2 vaccine administered in Phase 2, at Day 1.

Group XX: Control GroupActive Control1 Intervention

Eligible YA participants receive a single dose of Control 1 administered in Phase 1, at Day 1.

Group XXI: Control_Ph2_YA GroupActive Control1 Intervention

Eligible YA participants receive single dose of Control 1 vaccine administered in Phase 2, at Day 1.

0 / 3Eligibility 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

The mRNA-based vaccines, such as GSK4382276A, work by using messenger RNA to instruct cells to produce a viral protein, which then triggers an immune response without causing disease. This prepares the immune system to recognize and combat the actual influenza virus. Antiviral medications like oseltamivir inhibit the neuraminidase enzyme, which is essential for the virus to spread from infected cells to healthy ones. These treatments are important for flu patients as they help prevent infection, reduce symptom severity, and shorten the duration of illness.

Influenza clinical testing and oseltamivir treatment in hospitalized children with acute respiratory illness, 2015-2016.Oseltamivir plus usual care versus usual care for influenza-like illness in primary care: an open-label, pragmatic, randomised controlled trial.Prevention and treatment of respiratory viral infections: Presentations on antivirals, traditional therapies and host-directed interventions at the 5th ISIRV Antiviral Group conference.