Sanofi and Translate Bio Begin Phase 1/2 Clinical Trial of mRNA COVID-19 Vaccine Candidate
Sanofi and Translate Bio have initiated a Phase 1/2 clinical trial for MRT5500, an mRNA vaccine candidate against COVID-19. The trial will assess safety and immune response, with interim results expected in Q3 2021.
Paris and Lexington, MA – Sanofi Pasteur and Translate Bio announced on March 12, 2021, the commencement of a Phase 1/2 clinical trial for MRT5500, an mRNA vaccine candidate aimed at preventing COVID-19. The study is designed to evaluate the candidate's safety, immunogenicity, and reactogenicity in healthy adults.
This clinical trial is part of a broader effort to develop effective vaccines against the COVID-19 pandemic. According to preliminary preclinical data, the candidate has demonstrated high levels of neutralizing antibodies. A total of 415 participants are expected to enroll, with interim results anticipated in the third quarter of 2021.
In parallel, preclinical studies are underway to assess additional mRNA candidates targeting emerging variants of SARS-CoV-2. Efforts are also focused on improving the vaccine candidate's thermal stability, aiming for a -20°C storage temperature for late-stage trials and launch, with the goal of achieving stability at routine refrigerator temperatures (2-8°C).
The collaboration between Sanofi Pasteur and Translate Bio, initially established in 2018, was expanded in March 2020 to include the development of a COVID-19 vaccine. This partnership combines Sanofi's vaccine expertise with Translate Bio's mRNA platform technology.