mRNA Vaccine for Flu
Trial Summary
What is the purpose of this trial?
The purpose of this phase 1/2 study is to investigate the safety and immunogenicity of different doses (high, medium and low) of a second generation structurally designed (SD2) H5 messenger ribonucleic acid (mRNA) vaccine against pandemic H5 influenza virus (pandemic flu H5 hemagglutinin (HA) mRNA SD2) in healthy younger and older adults. The study will aim to identify the appropriate dose for further clinical development of a potential pandemic response vaccine. The study duration per participant will be approximately 13 months. There will be two injections of placebo or pandemic flu H5 mRNA vaccine 21 days apart at high, medium and low doses. Study visits/contact include: 7 study visits and 1 telephone call. Vaccination visits (including blood samples) will occur at Day 01 and Day 22. Short-term follow-up visits (including blood samples) will occur 8 and 21 days after each injection. Participants will be also followed up (including blood samples) at 3 and 6 months after 2nd injection, and at 12 months after 2nd injection for safety.
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 or long-term systemic corticosteroids, you may not be eligible to participate.
What data supports the effectiveness of the mRNA Vaccine for Flu treatment?
Research shows that mRNA vaccines can quickly and effectively produce strong immune responses against influenza, similar to their success with COVID-19 vaccines. In studies with animals, mRNA vaccines have provided protection against various strains of the flu, suggesting they could be a promising option for preventing flu infections.12345
What safety data exists for the mRNA vaccine for flu?
How is the mRNA vaccine for flu different from other treatments?
The mRNA vaccine for flu is unique because it uses mRNA technology, which allows for rapid production and targets the hemagglutinin (HA) protein of the virus, potentially offering more consistent protection compared to traditional vaccines that can vary in effectiveness due to changes in the virus. This approach is inspired by the success of mRNA vaccines for COVID-19.111121314
Eligibility Criteria
This trial is for healthy adults aged 18 and older who can't get pregnant or agree to use contraception. Women of childbearing potential must test negative for pregnancy. It's not suitable for those unable to follow the study schedule.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive two injections of placebo or pandemic flu H5 mRNA vaccine 21 days apart at high, medium, and low doses
Short-term Follow-up
Short-term follow-up visits occur 8 and 21 days after each injection to monitor safety and immunogenicity
Long-term Follow-up
Participants are followed up at 3, 6, and 12 months after the second injection for safety and immunogenicity
Treatment Details
Interventions
- Pandemic flu H5 HA mRNA SD2 vaccine
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sanofi
Lead Sponsor
Paul Hudson
Sanofi
Chief Executive Officer since 2019
Degree in Economics from Manchester Metropolitan University
Christopher Corsico
Sanofi
Chief Medical Officer
MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University