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Moderna Announces Initiation of Phase 1 Clinical Trial of mRNA-1469, Moderna's Investigational Vaccine Against Bundibugyo Ebolavirus

MRNA
  • Moderna initiated the first-in-human Phase 1 clinical trial for mRNA-1469 in Canada following Health Canada authorization.
  • The trial evaluates the safety, tolerability, & immunogenicity of the investigational mRNA vaccine against Bundibugyo ebolavirus (BDBV).
  • The study will enroll approximately 80 healthy adult participants across three Canadian sites.
  • This effort is part of an expanded collaboration with CEPI, which has committed up to US $50 million to support preclinical testing & the Phase 1 trial.
  • CEPI funding also supports scaled manufacturing of clinical trial doses to enable rapid advancement to Phase 2 & 3 studies if Phase 1 results are positive.
  • No vaccine is currently licensed for BDBV disease, which is responsible for an active outbreak in the Democratic Republic of the Congo causing over 3,000 cases & 1,400 deaths.
  • The BDBV outbreak has been declared a Public Health Emergency of International Concern by the WHO & a Public Health Emergency of Continental Security by Africa CDC.
  • Moderna has committed to making a minimum of 500,000 vaccine doses available at access pricing to low- & middle-income countries if the vaccine receives licensure.
  • The vaccine candidate utilizes Moderna's mRNA platform, building on prior filovirus research & the technology used for COVID-19 vaccines.