NOVA SCOTIA, CANADA / RankWire.AI / – Moderna has begun testing a new vaccine candidate in Phase 1 for Bundibugyo ebolavirus in Canada. The initial participant received the mRNA-1469 vaccine on August 3 at a site in Truro, Nova Scotia. This trial launches at a time when the virus continues to spread across multiple provinces in the Democratic Republic of the Congo. The World Health Organization has designated the situation as a public health emergency of international concern.
The clinical study will take place across three locations in Canada, enrolling approximately 80 healthy adult volunteers. The main objectives are to evaluate the safety, tolerability, and immune response generated by the vaccine. Since Phase 1 trials focus on safety, they do not determine the vaccine’s effectiveness at preventing infection. The Coalition for Epidemic Preparedness Innovations has pledged up to $50 million to support preclinical studies, the trial itself, and the production of additional research doses.
WHO reported 3,605 confirmed cases and 1,587 fatalities in DR Congo as of July 30. By that date, at least 651 patients had recovered. Updated data from CEPI on August 4 indicated the number of infections surpassed 3,800 with deaths exceeding 1,700. The outbreak has affected 49 health zones in the provinces of Ituri, North Kivu, South Kivu, Haut-Uélé, and Tshopo. Among these, 33 zones have reported recent cases, with Ituri accounting for 88% of confirmed infections.
Vaccine gap highlighted by outbreak
The WHO declared the outbreak an international public health emergency on May 17. This marks the 17th Ebola outbreak in DR Congo since the virus was first identified in 1976. The ongoing epidemic involves the Bundibugyo strain, which previously caused outbreaks in Uganda and DR Congo. Currently, there are no licensed vaccines or specific treatments for this Ebola species. Existing licensed vaccines are designed for Zaire ebolavirus, a different member of the virus family.
Bundibugyo ebolavirus spreads through direct contact with infected blood, body fluids, organs, or contaminated materials. Efforts by public health teams include expanding laboratory testing, contact tracing, clinical care, and infection prevention measures. As of July 30, authorities had identified 17,863 contacts for monitoring. WHO also documented 151 confirmed infections among health workers, including 44 deaths. The response has been hindered in some areas due to conflict, displacement, and attacks on health facilities.
Multiple vaccine candidates are under evaluation
Following the launch of a separate Phase 1 trial by the University of Oxford, Moderna’s study is part of a broader effort to develop a vaccine for Bundibugyo ebolavirus. Oxford researchers vaccinated their first volunteer on July 24 with a candidate based on the ChAdOx1 platform. The Serum Institute of India produced around 620,000 doses for stockpiling and supplied 4,000 investigational doses for clinical testing. Both programs are supported by CEPI as part of its Bundibugyo vaccine development portfolio.
Moderna’s mRNA-1469 candidate leverages the same technology platform as their COVID-19 vaccine. In addition, CEPI is backing two other candidates utilizing recombinant vesicular stomatitis virus technology. One was developed by IAVI and is being manufactured by Hilleman Laboratories, while the other was created by Public Health Vaccines. None of these candidates have received regulatory approval for public use. WHO emphasizes that surveillance, rapid diagnosis, patient care, safe burials, and community engagement are vital strategies for controlling the outbreak.