Moderna (Nasdaq: MRNA) has dosed the first participants in the first clinical trial of a vaccine specifically targeting Bundibugyo ebolavirus (BDBV). The mRNA candidate enters development as the company and the Coalition for Epidemic Preparedness Innovations (CEPI) prepare for potential accelerated advancement during the ongoing outbreak. The trial comes as the BDBV outbreak has surpassed 3,000 confirmed cases and 1,400 deaths — already the second-largest filovirus outbreak on record.
The Phase I study, authorized by Health Canada and running across three Canadian sites, will enroll approximately 80 healthy adult participants. Primary objectives are safety, tolerability, and immunogenicity. CEPI has committed up to USD 50 million to support preclinical work and the Phase I trial under an expanded collaboration with Moderna, and the company said it is manufacturing additional clinical doses in parallel with early-stage testing to accelerate potential Phase II and Phase III initiation if Phase I results support advancement.
mRNA-1469 uses Moderna's lipid nanoparticle-delivered mRNA platform to direct host cells to express the BDBV surface glycoprotein, the primary antigen for neutralizing antibody induction. The two approved filovirus vaccines — Merck's rVSV-vectored Ervebo (rVSV-ZEBOV-GP), which demonstrated 100% efficacy against Zaire ebolavirus in its pivotal ring vaccination trial, and Janssen's adenovirus prime-boost regimen Zabdeno (Ad26.ZEBOV) plus Mvabea (MVA-BN-Filo) — both target Zaire ebolavirus exclusively and offer no coverage against BDBV. The University of Oxford has also conducted a Phase Ia study of a ChAdOx1-vectored BDBV vaccine in healthy volunteers in the UK, though that program is no longer recruiting. Cross-trial comparisons are limited by differences in study design, duration, and patient populations.