A new phase one clinical trial kicked off this week for an mRNA-based vaccine against seasonal influenza — specifically the A/H3N2 strain — cooperatively developed by Sanofi Pasteur and Translate Bio.
With interim data expected by the end of the year, the trial will chart both safety and immunogenicity of the candidate’s coding on the hemagglutinin protein of the A/H3N2 flu strain. That strain was chosen because the seasons it dominates tend to be more severe, especially among at-risk patients like older adults and children.
“The first clinical trial of a seasonal mRNA flu vaccine candidate is an exciting milestone in our quest for the next generation of influenza vaccines,” Jean-François Toussaint, Global Head of Research and Development at Sanofi Pasteur, said. “We’ve all witnessed the promise of mRNA technology during this pandemic and are now looking to extend that promise to select annual vaccines.”
Up to 280 participants will be chosen for the trial. Dose levels will be tested on otherwise healthy adults between the ages of 18 and 49.
Over the course of the trial, two separate formulations of the vaccine will be tested: MRT5400 and MRT5401. Where they differ is in the lipid nanoparticle that contains the mRNA. The trial is being pursued following successful preclinical results, which demonstrated promising safety and immunogenicity data.
“We are pleased to have this second mRNA vaccine program underway with our partner Sanofi Pasteur,” Ronald Renaud, CEO of Translate Bio, said. “We believe that mRNA technology could have several advantages for a seasonal flu application, including the potential ability to demonstrate robust immune responses based on preclinical data to date, enable antigen specificity within a short timeframe from seasonal virus strain selection, and deploy agile manufacturing capacity. We look forward to evaluating the potential of these mRNA influenza vaccine candidates in this Phase 1 clinical trial.”