NOVA SCOTIA, CANADA / RankWire.AI / – Moderna has commenced 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 coincides with the continued spread of the virus across various provinces in the Democratic Republic of the Congo. The World Health Organization has categorized this outbreak as a public health emergency of international concern.
The trial will be conducted at three Canadian locations, enrolling approximately 80 healthy adults. The main focus of the study is to evaluate the vaccine’s safety, tolerability, and potential to elicit an immune response. It’s important to note that the trial will not establish vaccine efficacy in preventing infection, as Phase 1 studies primarily gather early safety data. The Coalition for Epidemic Preparedness Innovations has pledged up to $50 million to support preclinical research, the clinical trial itself, and the production of additional research doses.
WHO reported 3,605 confirmed cases and 1,587 deaths in DR Congo as of July 30. By that date, at least 651 individuals had recovered. As of August 4, CEPI’s updated figures indicated over 3,800 infections and more than 1,700 deaths. The outbreak has affected 49 health zones across the provinces of Ituri, North Kivu, South Kivu, Haut-Uélé, and Tshopo. Recent infections have been reported in 33 health zones, with Ituri accounting for 88% of confirmed cases.
Vaccine gap highlighted by ongoing outbreak
The WHO declared the outbreak a global public health emergency on May 17. It marks DR Congo’s 17th Ebola outbreak since the virus was first identified in 1976. This current epidemic involves the Bundibugyo strain, which previously caused outbreaks in Uganda and DR Congo. Currently, there are no approved vaccines or specific treatments targeting this particular Ebola species. Existing licensed vaccines are designed against Zaire ebolavirus, which is a different virus within the same family.
Bundibugyo ebolavirus transmits through direct contact with infected blood, body fluids, tissues, or contaminated items. In response, public health teams have expanded laboratory testing, contact tracing, clinical care, and infection prevention strategies. By July 30, officials had identified 17,863 contacts for monitoring. The WHO also reported 151 confirmed infections among healthcare workers, including 44 fatalities. Conflict, displacement, and attacks on health facilities have hampered access and response efforts in several affected regions.
Multiple vaccine candidates in early testing stages
Following Moderna’s announcement, a separate Phase 1 trial by the University of Oxford was also launched. Oxford researchers vaccinated their first participant on July 24 with a candidate based on the ChAdOx1 platform. The Serum Institute of India manufactured the vaccine, producing around 620,000 stockpiled doses and providing 4,000 investigational doses for clinical testing. Both programs are supported by CEPI as part of its efforts to develop a vaccine for Bundibugyo ebolavirus.
Moderna’s mRNA-1469 candidate utilizes the same platform technology as the company’s COVID-19 vaccine. Additionally, CEPI is backing two other candidates based on recombinant vesicular stomatitis virus technology. One was developed by IAVI with manufacturing led by Hilleman Laboratories, while the other was produced by Public Health Vaccines. None of these candidates has yet received regulatory approval for widespread use. WHO emphasizes that surveillance, rapid diagnostics, patient management, safe burials, and community engagement remain crucial to controlling the outbreak.