Cambridge, Massachusetts – August 4, 2026
Moderna, Inc. has announced the initiation of a Phase 1 clinical trial evaluating mRNA-1469, the company’s investigational mRNA vaccine designed to prevent disease caused by Bundibugyo ebolavirus (BDBV), a strain of Ebola virus for which no licensed vaccine currently exists. Following authorization from Health Canada, the first participants have now been vaccinated in the first-in-human clinical study being conducted across three research sites in Canada. The milestone further expands Moderna’s infectious disease pipeline while demonstrating the continued versatility of its mRNA platform, which previously enabled the rapid development and global deployment of COVID-19 vaccines. Developed through Moderna’s expanded strategic collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI), the investigational vaccine aims to address a significant unmet public health need by providing protection against one of the most dangerous filoviruses currently responsible for a major Ebola outbreak. The program also reflects the growing importance of international partnerships in accelerating vaccine innovation against emerging infectious diseases.
Phase 1 Trial Evaluates Safety and Immune Response
The Phase 1 clinical trial will evaluate the safety, tolerability, and immunogenicity of mRNA-1469 in approximately 80 healthy adult volunteers across three Canadian clinical sites. The first-in-human study represents an important milestone for Moderna’s expanding portfolio of mRNA-based vaccines targeting high-priority infectious diseases. The vaccine has been developed using Moderna’s proven messenger RNA platform, enabling rapid vaccine design and scalable manufacturing while leveraging years of research into filoviruses, including Ebola-related pathogens. Supported by CEPI, the collaboration includes funding for preclinical research, Phase 1 clinical development, and the parallel production of additional clinical trial material. This strategy is intended to enable rapid progression into larger Phase 2 and Phase 3 clinical studies should early safety and immune response data support continued development. The accelerated approach reflects global efforts to improve preparedness for future infectious disease outbreaks through advanced vaccine technologies.
Investigational Vaccine Targets Unmet Ebola Threat
Bundibugyo ebolavirus (BDBV) is one of several viruses capable of causing Ebola virus disease, yet unlike Zaire ebolavirus, there are currently no approved vaccines specifically indicated for BDBV infection. The investigational mRNA-1469 vaccine has been developed to address this critical gap in global health preparedness. The current BDBV outbreak in the Democratic Republic of the Congo has become one of the largest Ebola outbreaks recorded, resulting in thousands of confirmed infections and significant mortality. International public health authorities have designated the outbreak as both a Public Health Emergency of International Concern (PHEIC) and a Public Health Emergency of Continental Security (PHECS), highlighting the urgent need for new preventive interventions. Moderna’s use of its mRNA technology aims to provide a flexible platform capable of rapidly responding to evolving infectious disease threats while supporting future pandemic preparedness initiatives.
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Global Collaboration Supports Future Vaccine Access
The collaboration between Moderna and CEPI extends beyond early clinical development by supporting future manufacturing readiness and equitable global access. CEPI has committed up to US$50 million toward the development program, including support for clinical manufacturing and preparedness for later-stage trials if Phase 1 results prove successful. Moderna has also committed, upon potential regulatory approval, to making at least 500,000 vaccine doses available for timely distribution to low- and middle-income countries through an access pricing framework. This strategy reinforces the company’s commitment to expanding global vaccine access while strengthening international preparedness against emerging infectious diseases. As Moderna continues to broaden its infectious disease vaccine pipeline, the initiation of the mRNA-1469 Phase 1 clinical trial represents another significant milestone in advancing next-generation mRNA vaccines for diseases with substantial unmet medical need and limited preventive treatment options.
Source: Moderna press release
