Moderna has taken a major step in the global fight against Ebola after the first participants were vaccinated in a Phase 1 clinical trial in Canada testing the company’s experimental mRNA vaccine candidate, mRNA-1469, designed to prevent Bundibugyo ebolavirus (BDBV) disease.
The milestone follows authorization from Health Canada and marks the first clinical evaluation of an mRNA vaccine specifically targeting BDBV — a strain of Ebola for which no approved vaccine currently exists.
The vaccine candidate is being developed using Moderna’s mRNA platform, the same technology that enabled rapid vaccine development and large-scale global deployment during the COVID-19 pandemic. The program also builds on the company’s ongoing research into filoviruses, including Ebola-related diseases.
"Vaccinating the first participants with mRNA-1469 marks an important milestone in advancing a vaccine candidate against Bundibugyo ebolavirus, for which no approved vaccine currently exists," said Stéphane Bancel, Chief Executive Officer of Moderna. "We are grateful to CEPI, Health Canada, the investigators and study participants for their contributions to advance this work."
The Phase 1 trial is being supported through Moderna’s expanded strategic collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI), which has committed up to US $50 million to fund preclinical research and the early-stage clinical study.
The partnership also includes support for manufacturing additional clinical trial doses alongside early development, allowing the company to move quickly toward larger Phase 2 and Phase 3 trials if initial results demonstrate safety and effectiveness.
"Getting Moderna's vaccine candidate into a Phase 1 trial this rapidly is a major step forward in the fight against this deadly outbreak," said Richard Hatchett, CEPI's Chief Executive Officer.
"This fast-growing epidemic is already the second-largest Ebola outbreak in history, and cases are rising more quickly than they did in the 2014 - 2016 West Africa epidemic which remains the largest on record. Every day matters, and every vaccine candidate in clinical trials gives us another shot at getting a safe, effective vaccine to the people who need it as swiftly as possible."
The first-in-human study, registered under ClinicalTrials.gov identifier NCT07737717, is being conducted at three Canadian sites and will assess the safety, tolerability and immune response generated by mRNA-1469 in healthy adults. The trial is expected to enroll around 80 participants.
