Sanofi Pasteur, the vaccines global business unit of Sanofi and Translate Bio (NASDAQ: TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company, have initiated a Phase 1 clinical trial evaluating an mRNA-based investigational vaccine against seasonal influenza.

The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. Flu seasons that are dominated by A/H3N2 strain circulation activity tend to be more severe, especially among those considered at-risk such as older adults and younger 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. We've all witnessed the promise of mRNA technology during this pandemic and are now looking to extend that promise to select annual vaccines”, said Jean-François Toussaint, Global Head of Research and Development, Sanofi Pasteur. “In line with our global leadership and our 70-year history of protecting people with influenza vaccines, we will always focus on developing products that demonstrate protection beyond flu, as we believe it is critical to demonstrate protecting patients from hospitalizations due to cardiovascular events and pneumonia. We look forward to sharing initial results by year-end.”

“We are pleased to have this second mRNA vaccine program underway with our partner Sanofi Pasteur,” said Ronald Renaud, chief executive officer, Translate Bio. “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.”

Sanofi and Translate Bio have developed and will evaluate two formulations of the vaccine (MRT5400 and MRT5401) in the Phase 1 influenza mRNA vaccine clinical trial. The two formulations differ in the lipid nanoparticle (LNP) that contains the mRNA.

The trial follows successful preclinical research which demonstrated promising safety and immunogenicity. Preclinical results were shared previously at the 8th annual mRNA Healthcare Conference in November 2020. 

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