NOVA SCOTIA, CANADA / RankWire.AI / – Moderna has initiated a Phase 1 clinical trial for an experimental vaccine targeting Bundibugyo ebolavirus in Canada. The inaugural participant received the mRNA-1469 vaccine on August 3 at a facility in Truro, Nova Scotia. This development occurs as the virus continues to spread across multiple provinces in the Democratic Republic of the Congo. The World Health Organization has designated the outbreak as a public health emergency of international concern.
The trial will be conducted at three Canadian locations and aims to recruit approximately 80 healthy adults. Investigators will evaluate the vaccine’s safety profile, tolerability, and capacity to elicit an immune response. As a Phase 1 study, it will not determine the vaccine’s effectiveness in preventing infection. The Coalition for Epidemic Preparedness Innovations has pledged up to $50 million to support preclinical research, the trial itself, and the production of additional doses for research purposes.
WHO reported 3,605 confirmed cases and 1,587 fatalities in DR Congo through July 30. By that date, at least 651 patients had recovered. Updated data from CEPI on August 4 indicated that infections exceeded 3,800 with more than 1,700 deaths. The outbreak has affected 49 health zones across Ituri, North Kivu, South Kivu, Haut-Uélé, and Tshopo provinces. Recent infections have been reported in 33 health zones, with Ituri accounting for 88% of confirmed cases.
Vaccine Shortage Highlights Urgent Need
The WHO officially declared this outbreak an international public health emergency on May 17. It marks the 17th Ebola outbreak in DR Congo since scientists first identified the virus in 1976. The current epidemic involves the Bundibugyo species, which previously caused outbreaks in Uganda and DR Congo. Currently, no approved vaccines or targeted treatments exist for this Ebola strain. Existing licensed Ebola vaccines are designed for Zaire ebolavirus, a different member of the virus family.
Bundibugyo ebolavirus spreads primarily through direct contact with infected blood, body fluids, organs, or contaminated materials. Public health efforts have ramped up laboratory testing, contact tracing, clinical care, and infection prevention strategies. As of July 30, authorities had identified 17,863 contacts for monitoring. WHO also noted 151 confirmed infections among healthcare workers, including 44 deaths. Ongoing conflict, displacement, and attacks on health infrastructure have hampered response activities in several impacted areas.
Several Candidates Undergoing Clinical Evaluation
This Moderna initiative follows the launch of a separate Phase 1 trial by the University of Oxford. The Oxford team vaccinated their first volunteer on July 24 with a candidate based on the ChAdOx1 platform. The Serum Institute of India has manufactured roughly 620,000 doses for stockpiling and supplied 4,000 investigational doses for testing. Both programs are supported by CEPI as part of its effort to develop a vaccine against Bundibugyo ebolavirus.
Moderna’s mRNA-1469 platform utilizes the same technology as the company’s COVID-19 vaccine. Additionally, CEPI is supporting two other candidates employing recombinant vesicular stomatitis virus technology. One was developed by IAVI with manufacturing led by Hilleman Laboratories, and the other by Public Health Vaccines. None of these candidates have gained regulatory approval for widespread use. According to WHO, controlling the outbreak depends on ongoing surveillance, swift diagnosis, patient care, safe burial practices, and active community engagement.