Moderna has started a Phase 1 trial of mRNA-1469, an investigational mRNA vaccine targeting the Bundibugyo Ebola strain, with Health Canada authorizing the study at three Canadian sites. About 80 healthy adults will be enrolled to evaluate safety, tolerability and immune response. CEPI has pledged up to $50 million to support development and parallel manufacturing to accelerate later-stage trials if early data are positive. Moderna has also pledged at least 500,000 doses to low- and middle-income countries if the vaccine is approved.
Moderna Launches Phase 1 Trial of mRNA-1469 Vaccine Targeting Bundibugyo Ebola
Moderna starts Phase 1 trial of mRNA Bundibugyo Ebola vaccine
Moderna began vaccinating the first participants on Tuesday in a Phase 1 clinical trial of mRNA-1469, an investigational messenger RNA vaccine designed to protect against the Bundibugyo strain of Ebola virus — a strain for which no licensed vaccine currently exists.
Trial Design and Scope
Health Canada has authorized the study, which is being conducted at three sites across Canada. The randomized Phase 1 trial is expected to enroll roughly 80 healthy adult volunteers and will evaluate the candidate's safety, tolerability and ability to elicit an immune response, Moderna said.
Technology and Partnership
mRNA-1469 uses the same mRNA platform Moderna deployed for its COVID-19 vaccine. The study is part of an expanded collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI), which has pledged up to $50 million to support preclinical development, this Phase 1 trial and parallel manufacturing of additional doses. That parallel manufacturing strategy is intended to allow Phase 2 and Phase 3 studies to begin quickly if early results are favorable.
"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," Moderna Chief Executive Officer Stéphane Bancel said in a statement.
Outbreak Context
The Bundibugyo strain is driving an outbreak in the Democratic Republic of Congo. According to Reuters citing U.S. Centers for Disease Control and Prevention figures, the outbreak had reached 3,748 confirmed cases and 1,657 confirmed deaths as of Aug. 1. Both the World Health Organization and the Africa CDC have declared the situation a public health emergency.
CEPI Chief Executive Officer Dr. Richard Hatchett noted that the outbreak already ranks as the second-largest Ebola epidemic in history, with cases rising faster than during the 2014–2016 West Africa epidemic.
Global Access Commitment
Moderna and CEPI announced their collaboration earlier this year. CEPI selected Moderna alongside two other developers — the University of Oxford and the International AIDS Vaccine Initiative — each pursuing different vaccine platforms. Moderna says that if mRNA-1469 ultimately receives regulatory approval, it has pledged to supply at least 500,000 doses to low- and middle-income countries at preferential pricing as part of its agreement with CEPI.
Outlook
Phase 1 studies primarily assess safety and immune response in a small group of healthy adults. If results are promising, the combination of CEPI funding and parallel manufacturing could speed initiation of larger Phase 2 and Phase 3 trials to determine efficacy and broader safety.
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