mRNA Vaccine for Flu
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.12345Why 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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 2 injections of pandemic flu H5 mRNA vaccine or placebo 21 days apart
Follow-up
Participants are monitored for safety and effectiveness after treatment, including adverse events and antibody titers
What Are the Treatments Tested in This Trial?
Interventions
- Pandemic flu H5 mRNA vaccine
Pandemic flu H5 mRNA vaccine is already approved in United States, European Union for the following indications:
- Prevention of disease caused by influenza A (H5N1) virus
- Prevention of influenza A (H5N1) virus infection
- Prevention of influenza A (H5N1) virus infection
- Prevention of influenza A (H5N1) virus infection
- Prevention of influenza A (H5N1) virus infection
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sanofi Pasteur, a Sanofi Company
Lead Sponsor
Paul Hudson
Sanofi Pasteur, a Sanofi Company
Chief Executive Officer since 2019
Degree in Economics from Manchester Metropolitan University
Dr. Thomas Triomphe
Sanofi Pasteur, a Sanofi Company
Chief Medical Officer since 2020
MD from Tehran University of Medical Sciences