mRNA Vaccine for Flu
Trial Summary
What is the purpose of this trial?
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 comparison with placebo in 276 healthy adult participants to select the adequate dose for further clinical development. The duration per participant will be approximately 13 months.
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.
What data supports the idea that mRNA Vaccine for Flu is an effective treatment?
The available research shows that mRNA vaccines for flu, specifically those targeting the H5N1 strain, are effective in generating a strong immune response. Clinical studies have found that two doses of the vaccine are generally needed to achieve the desired level of immunity. The use of adjuvants, which are substances that enhance the body's immune response to the vaccine, allows for less of the vaccine to be used while still being effective. Additionally, these vaccines can provide cross-protection against different strains of the virus. Compared to other treatments, the mRNA vaccine with adjuvants has shown to boost immunity more effectively, as seen in studies with ferrets where it reduced viral presence and lung damage. This suggests that the mRNA vaccine is a promising option for flu prevention.12345
What data supports the effectiveness of the mRNA Vaccine for Flu treatment?
Research shows that H5N1 vaccines, especially when combined with adjuvants (substances that enhance the body's immune response), can produce strong immune responses and offer cross-protection against different virus strains. Studies also indicate that adjuvanted vaccines can boost immunity and provide better protection, as seen in trials with other influenza vaccines.12345
What safety data is available for the mRNA flu vaccine?
The safety data for the mRNA flu vaccine, including variants like the H5N1 vaccine, shows that it is generally well-tolerated across different age groups. Studies on vaccines such as Aflunov, an adjuvanted H5N1 vaccine, indicate it is safe and well-tolerated in infants, children, adolescents, adults, and the elderly. Clinical trials, including a phase III trial with 5071 adults, reported that the vaccine's safety and reactogenicity profile is clinically acceptable, with pain being the most common adverse event. Other studies confirm that the vaccine is safe and immunogenic, with minimal adverse events like injection site pain, malaise, and fever. Overall, the vaccine meets safety criteria for pandemic influenza vaccines.56789
Is the mRNA vaccine for flu safe for humans?
The mRNA vaccine for flu, evaluated under various names like Aflunov and others, has been shown to be safe in humans. Clinical studies have found it to be well-tolerated in different age groups, with common side effects being mild, such as pain at the injection site. Serious adverse events were rare, making the vaccine's safety profile acceptable for use against pandemic influenza.56789
Is the mRNA Vaccine for Flu a promising treatment?
Yes, the mRNA Vaccine for Flu is promising because it can quickly provide protection against the H5N1 flu virus, which could cause a pandemic. It can be given before a pandemic starts to prepare people and help them build strong immunity. The vaccine has shown to be safe and effective in creating a strong immune response, even against different strains of the virus.1561011
How is the mRNA vaccine for flu different from other flu treatments?
The mRNA vaccine for flu is unique because it uses a genetic approach to stimulate the immune system, potentially offering cross-protective and long-lasting responses against various strains of the H5N1 virus. Unlike traditional vaccines, it can be administered quickly in the event of a pandemic, and its effectiveness can be enhanced with adjuvants, which are substances that boost the body's immune response to the vaccine.1561011
Eligibility Criteria
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
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
Treatment Details
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