12.03.2021 08:20:54
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Sanofi, Translate Bio Start Phase 1/2 Clinical Trial Of MRNA COVID-19 Vaccine Candidate
(RTTNews) - French drug major Sanofi (SNYNF, SNY) announced Friday that its vaccines business unit Sanofi Pasteur and Translate Bio (TBIO), a clinical-stage messenger RNA or mRNA therapeutics company, have started the Phase 1/2 clinical trial for MRT5500, an mRNA vaccine candidate against SARS-CoV-2, the virus that causes COVID-19.
The companies expect interim results from this trial in the third quarter of 2021.
The Phase 1/2 clinical trial is a randomized, double blind and placebo-controlled trial designed to evaluate the safety, reactogenicity and immunogenicity of MRT5500, a COVID-19 vaccine candidate.
A total of 415 healthy adults 18 years of age and older are expected to be enrolled in the trial across 13 investigational sites. Clinical trial participants will receive one dose of MRT5500, or two doses 21 days apart. Three different dose levels will be investigated.
Preclinical studies are ongoing and will continue over the next several months to evaluate whether MRT5500, as well as additional mRNA vaccine candidates, will induce neutralizing antibodies against the emerging SARS-CoV-2 variants, with the potential to inform current and future clinical development.
MRT5500 is being developed under a collaboration and license agreement between Sanofi Pasteur and Translate Bio.
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