NOVA SCOTIA, CANADA / RankWire.AI / – Moderna has commenced a Phase 1 clinical trial of a new vaccine targeting Bundibugyo ebolavirus in Canada. The initial participant received the mRNA-1469 vaccine on August 3 at a facility in Truro, Nova Scotia. This trial launches 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 across three sites in Canada, enrolling approximately 80 healthy adults. The primary goals are to evaluate the vaccine’s safety, tolerability, and its capacity to generate an immune response. It is important to note that this Phase 1 study will not assess the vaccine’s effectiveness in preventing infection, as early-phase trials focus on safety data. The WHO documented 3,605 confirmed cases and 1,587 deaths in DR Congo through July 30, with at least 651 recoveries by that date. As of August 4, CEPI updated these figures, reporting over 3,800 infections and more than 1,700 deaths. The cases are spread across 49 health zones in Ituri, North Kivu, South Kivu, Haut-Uélé, and Tshopo provinces, with 33 zones reporting recent infections and Ituri accounting for 88% of confirmed cases.
Vaccine gap highlighted by outbreak
On May 17, WHO declared the outbreak an international public health emergency. This marks the 17th Ebola outbreak in DR Congo since the virus was first identified in 1976. The current situation involves the Bundibugyo strain, which has previously caused outbreaks in Uganda and DR Congo. Currently, there are no licensed vaccines or targeted treatments for this specific Ebola species. Existing licensed vaccines are designed against Zaire ebolavirus, a different virus in the same family.
Bundibugyo ebolavirus transmits through direct contact with infected blood, body fluids, organs, or contaminated materials. Public health officials have expanded efforts in laboratory testing, contact tracing, clinical management, and infection control. As of July 30, authorities identified 17,863 contacts for monitoring. WHO also reported 151 confirmed infections among healthcare workers, including 44 deaths. Ongoing conflict, displacement, and attacks on healthcare infrastructure have hampered access and response efforts in several affected regions.
Multiple vaccine candidates enter clinical testing
This Moderna trial follows a separate Phase 1 study initiated by the University of Oxford. Oxford researchers vaccinated their first volunteer on July 24 with a candidate based on the ChAdOx1 platform. The Serum Institute of India produced the Oxford vaccine, stockpiling around 620,000 doses and supplying 4,000 investigational doses for clinical trials. Both programs are supported by CEPI as part of its Bundibugyo vaccine development efforts.
Moderna’s mRNA-1469 vaccine employs the same technology platform as the company’s COVID-19 vaccine. Additionally, CEPI supports two other candidates utilizing recombinant vesicular stomatitis virus technology. One candidate was developed by IAVI and manufactured by Hilleman Laboratories, while the other was created by Public Health Vaccines. None of these candidates has yet received regulatory approval for widespread use. According to WHO, efforts such as surveillance, rapid diagnostics, patient care, safe burials, and community engagement remain vital to controlling the outbreak.