The mRNA vaccine candidate, MRT5500, works to fight the SARS-CoV-2 virus, which causes COVID-19, the companies, based in Lexington, Mass., and Paris respectively, said.
Sanofi will pay Translate Bio $25 million on achievement of the milestone, they said. The drug is being developed under a collaboration and license agreement between the two companies.
Preclinical data has shown “high neutralizing antibody levels,” the companies said in a statement.
The Phase 1/2 study will assess the “safety, immune response and reactogenicity" of the vaccine, they said.
The study is set to include 415 participants ages 18 and older at 13 sites.
Within the study, participants will get either one dose of the vaccine, or two doses 21 days apart. The trial will test three dose levels of the vaccine, 15, 45 and 135 micrograms, as well as its side-effects profile, media reports say.
The companies expect to have interim results of the MRT5500 trial in the third quarter.
Together, the companies are doing clinical trials of other mRNA candidates to address COVID-19 variants.
Translate Bio shares at last check had edged up 0.2% to $24.12. Meanwhile, Sanofi shares slipped 0.3% to $47.71.