NOVA SCOTIA, CANADA / RankWire.AI / – Moderna has launched a Phase 1 clinical trial of a novel vaccine targeting Bundibugyo ebolavirus in Canada. The trial began with the first participant receiving the mRNA-1469 vaccine on August 3 at a location in Truro, Nova Scotia. This development coincides with the ongoing spread of the virus across several provinces in the Democratic Republic of the Congo. The World Health Organization has labeled the outbreak as a public health emergency of international concern.
The research will be conducted at three sites in Canada, enrolling approximately 80 healthy adults. The main objectives are to evaluate the vaccine’s safety, tolerability, and capacity to elicit an immune response. It is important to note that this Phase 1 trial will not determine the vaccine’s effectiveness in preventing infection, as early safety data is the primary focus at this stage. The Coalition for Epidemic Preparedness Innovations has committed up to $50 million to fund 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 through July 30. As of that date, at least 651 patients had recovered. Updated figures from CEPI on August 4 indicated that cases had risen to over 3,800 with deaths exceeding 1,700. The outbreak has affected 49 health zones across Ituri, North Kivu, South Kivu, Haut-Uélé, and Tshopo provinces, with 33 zones reporting recent infections. Notably, Ituri accounts for 88% of confirmed cases.
Vaccine gap exposed by outbreak
On May 17, WHO declared the outbreak a public health emergency of international concern. This marks the 17th Ebola outbreak in DR Congo since the virus was first identified in 1976. The current epidemic involves the Bundibugyo strain, which previously caused outbreaks in Uganda and DR Congo. At present, no licensed vaccine or specific treatment targets this particular Ebola species. Existing licensed vaccines are designed against Zaire ebolavirus, a different member of the virus family.
Bundibugyo ebolavirus transmits through direct contact with infected blood, body fluids, organs, or contaminated materials. Health authorities have expanded laboratory testing, contact tracing, clinical care, and infection prevention efforts. By July 30, officials had identified 17,863 contacts for monitoring. WHO also reported 151 confirmed infections among healthcare workers, including 44 fatalities. Ongoing conflict, displacement, and attacks on health facilities have hampered response efforts in several affected regions.
Multiple vaccine candidates in clinical testing
This Moderna trial follows a separate Phase 1 study initiated by the University of Oxford, which vaccinated its first volunteer on July 24 using a candidate based on the ChAdOx1 platform. The Serum Institute of India produced approximately 620,000 stockpiled doses of the Oxford vaccine and supplied 4,000 investigational doses for testing. Both programs are supported by CEPI as part of its efforts to develop a vaccine for Bundibugyo ebolavirus.
Moderna’s candidate, mRNA-1469, employs the same underlying technology platform as its COVID-19 vaccine. Additionally, CEPI is supporting 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 created by Public Health Vaccines. None of these candidates has received regulatory approval for public use. According to WHO, maintaining surveillance, rapid diagnosis, patient care, safe burial practices, and community engagement remain crucial to controlling the outbreak.