mRNA Vaccine for Flu

Not currently recruiting at 17 trial locations
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Overseen ByTrial Transparency email recommended (Toll free for US & Canada)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new mRNA vaccine for the H5 flu strain, which could cause a pandemic. Researchers aim to determine the best dose by comparing low, medium, and high doses of the vaccine with a placebo. They seek healthy adults who have not experienced certain health issues, such as heart inflammation or bleeding disorders, and have not participated in similar vaccine studies. Participants will be involved in the trial for about 13 months. As a Phase 1 and Phase 2 trial, this study focuses on understanding the vaccine's effects and measuring its effectiveness in an initial, smaller group, offering participants the chance to contribute to groundbreaking research.

Do I need to stop taking my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy, long-term systemic corticosteroids, or anticoagulants, you may not be eligible. It's best to discuss your specific medications with the trial investigator.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy, long-term corticosteroids, or anticoagulants, you may not be eligible to participate.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that similar flu vaccines, such as AUDENZ, are generally safe. Common side effects are mild to moderate, including pain at the injection site, tiredness, and headaches. These reactions resemble those from other flu vaccines.

This study tests different doses of a new mRNA flu vaccine. mRNA vaccines tend to cause fewer severe reactions because they don't spread as much in the body, potentially leading to fewer unwanted effects.

Since this trial is in its early stages, it primarily focuses on safety. Early trials like this one aim to identify any serious safety issues. Those considering participation should know that these trials follow strict rules to ensure participant safety.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about the pandemic flu H5 mRNA vaccine because it uses mRNA technology, which is a game-changer in vaccine development. Unlike traditional flu vaccines, which often use inactivated viruses or viral proteins, this mRNA vaccine works by instructing cells to produce a protein that triggers an immune response. This method could lead to faster and more flexible vaccine production, especially useful in responding to emerging flu strains. Additionally, mRNA vaccines have shown promising safety and efficacy profiles in other applications, which adds to the excitement surrounding their potential in combating pandemic flu.

What evidence suggests that this trial's treatments could be effective for pandemic flu?

Research has shown that mRNA vaccines for the flu, such as the pandemic flu H5 vaccine in this trial, have been very effective in past studies. For instance, three weeks after receiving the second dose of a similar mRNA flu vaccine, 97.8% of participants exhibited strong immune responses. This indicates that the vaccine helps the body combat the H5 flu strain. mRNA technology is promising because it allows for rapid updates to vaccines, making them more adaptable to various flu strains. Early results suggest that mRNA vaccines could effectively prevent flu outbreaks.678910

Are You a Good Fit for This Trial?

This clinical trial is open to healthy adults aged 18 and older who are interested in testing a new pandemic flu H5 mRNA vaccine. The study aims to find the right dose for further research. Participants will be involved for about 13 months.

Inclusion Criteria

I am not pregnant or breastfeeding and either cannot have children or will use birth control.
I am a woman who can have children and have tested negative for pregnancy recently.

Exclusion Criteria

I have a weak immune system or have been on long-term steroids.
Chronic illness that might interfere with study conduct or completion
Alcohol, prescription drug, or substance abuse that might interfere with study conduct or completion
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2 injections of pandemic flu H5 mRNA vaccine or placebo 21 days apart

3 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and antibody titers

12 months
Multiple visits (in-person and virtual) at Day 43, Day 112, and Day 202

What Are the Treatments Tested in This Trial?

Interventions

  • Pandemic flu H5 mRNA vaccine
Trial Overview The trial is testing three different doses of a new pandemic flu H5 mRNA vaccine against a placebo, which has no active ingredients. It's designed to see how safe the vaccine is and how well it triggers an immune response.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 3: High Dose Pandemic flu H5 mRNA vaccineExperimental Treatment1 Intervention
Group II: Group 2: Medium Dose Pandemic flu H5 mRNA vaccineExperimental Treatment1 Intervention
Group III: Group 1: Low Dose Pandemic flu H5 mRNA vaccineExperimental Treatment1 Intervention
Group IV: Group 4: PlaceboPlacebo Group1 Intervention

Pandemic flu H5 mRNA vaccine is already approved in United States, European Union for the following indications:

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Approved in United States as Audenz for:
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Approved in European Union as Aflunov for:
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Approved in European Union as Adjupanrix for:
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Approved in European Union as Foclivia for:
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Approved in European Union as Pumarix for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sanofi Pasteur, a Sanofi Company

Lead Sponsor

Trials
429
Recruited
6,140,000+
Paul Hudson profile image

Paul Hudson

Sanofi Pasteur, a Sanofi Company

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Dr. Thomas Triomphe profile image

Dr. Thomas Triomphe

Sanofi Pasteur, a Sanofi Company

Chief Medical Officer since 2020

MD from Tehran University of Medical Sciences

Published Research Related to This Trial

The MF59-adjuvanted A/H5N1 pre-pandemic vaccine demonstrated strong immunogenicity, achieving a seroconversion rate of 56% in adults and meeting European licensure criteria, indicating it can effectively stimulate an immune response against the virus.
The vaccine was well tolerated, showing lower reactogenicity compared to the seasonal influenza vaccine, making it a suitable option for pre-pandemic vaccination in both adults and the elderly.
Safety and immunogenicity of an MF59(®)-adjuvanted A/H5N1 pre-pandemic influenza vaccine in adults and the elderly.Vesikari, T., Forstén, A., Herbinger, KH., et al.[2022]
Aflunov(®), a prepandemic monovalent A/H5N1 influenza vaccine, has been shown to be safe and well-tolerated across various age groups, including infants and the elderly, with no observed maternal or embryo-fetal toxicity in nonclinical studies.
The vaccine demonstrated strong immunogenicity against both related and different strains of the H5N1 virus, suggesting it could effectively prepare the immune system for potential future pandemics caused by this virus.
Aflunov(®): a prepandemic influenza vaccine.Gasparini, R., Amicizia, D., Lai, PL., et al.[2013]
In a phase III clinical trial involving 5071 healthy adults, the AS-H5N1 vaccine showed a clinically acceptable safety and reactogenicity profile, with less than 1% of participants withdrawing due to adverse events.
While more participants in the AS-H5N1 group reported general or local adverse events compared to those receiving the licensed seasonal influenza vaccine, no serious adverse events related to vaccination were reported.
Safety and reactogenicity profile of an adjuvanted H5N1 pandemic candidate vaccine in adults within a phase III safety trial.Rümke, HC., Bayas, JM., de Juanes, JR., et al.[2021]

Citations

Moderna Highlights Seasonal Flu and H5 Pandemic ...Three weeks after the second dose, the immune responses in 97.8% of participants (95%CI: 95.4, 99.2) were at or above levels considered ...
Moderna announces promising efficacy results from mRNA ...In a press release, the company said its candidate flu vaccine, called mRNA 1010, showed superior results, with an rVE of 26.6% in the overall ...
Promising strategy for developing mRNA-based universal ...The current review discusses the promising strategy of using a potentially universal IAV mRNA vaccine based on conserved elements for humans, poultry, and pigs.
Study on mRNA Vaccine for Pandemic FluThis study investigates a vaccine for the H5 strain of pandemic flu, which is a type of influenza virus. The purpose is to find the right ...
A vaccine central in A(H5) influenza antigenic space ...This work showcases the rational design of subtype-wide influenza A(H5) pre-pandemic vaccines and demonstrates the value of antigenic maps for ...
Package Insert - AUDENZNo clinically relevant differences in safety between subjects 65 years of age and older and younger subjects were observed [see Adverse Reactions. (6)]. 11 ...
An overview of influenza H5 vaccinesThe most common adverse reactions are mild to moderate, such as injection site pain, fatigue, and headaches, which are similar to what has been ...
AUDENZAUDENZ is an inactivated vaccine indicated for active immunization for the prevention of disease caused by the influenza A virus H5N1 subtype ...
NCT06727058 | Study to Evaluate Safety and ...The purpose of this study is to evaluate a pandemic flu H5 strain messenger ribonucleic acid (mRNA) vaccine at 3 dose levels (low, medium, and high) in ...
Immunogenic and Protective Properties of mRNA Vaccine ...It was observed that naked mRNA-RBD delivered by JI does not spread systemically, resulting in reduced vaccine reactogenicity and adverse effects. In this study ...
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