NOVA SCOTIA, CANADA / RankWire.AI / – Moderna has initiated a Phase 1 clinical trial for an experimental vaccine targeting Bundibugyo ebolavirus in Canada. The first participant was vaccinated with mRNA-1469 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 take place at three Canadian sites, aiming to enroll approximately 80 healthy adults. The primary goals are to evaluate the vaccine’s safety profile, tolerability, and its potential to elicit an immune response. Since Phase 1 studies focus on early safety data, the trial will not determine whether the vaccine prevents infection. The Coalition for Epidemic Preparedness Innovations has pledged up to $50 million to fund preclinical research, the 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, with at least 651 patients having recovered by that date. Updated data from CEPI on August 4 indicated over 3,800 infections and more than 1,700 deaths. The cases are distributed across 49 health zones in Ituri, North Kivu, South Kivu, Haut-Uélé, and Tshopo provinces. Among these, 33 zones have reported recent infections, with Ituri accounting for 88% of the confirmed cases.
Vaccine gap highlighted by outbreak
On May 17, WHO declared the outbreak an international public health emergency. It marks DR Congo’s 17th Ebola outbreak since the virus was first identified in 1976. The current outbreak involves the Bundibugyo strain, which previously caused outbreaks in Uganda and DR Congo. Presently, no approved vaccines or specific treatments exist for this Ebola strain. Licensed Ebola vaccines protect against Zaire ebolavirus, a different member of the virus family.
Bundibugyo ebolavirus is transmitted through direct contact with infected blood, body fluids, organs, or contaminated materials. In response, public health teams have intensified laboratory testing, contact tracing, clinical care, and infection prevention efforts. By July 30, authorities 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 access and response activities in several affected regions.
Multiple vaccine candidates in early testing phases
Following Moderna’s announcement, a separate Phase 1 trial launched by the University of Oxford is also underway. The Oxford team vaccinated their first volunteer on July 24 with a candidate based on the ChAdOx1 platform. The Serum Institute of India, which manufactured the Oxford vaccine, has produced around 620,000 stockpiled doses and supplied 4,000 investigational doses for clinical testing. Both programs receive support from CEPI as part of its efforts to develop a vaccine for the Bundibugyo strain.
Moderna’s mRNA-1469 utilizes the same technology platform as their COVID-19 vaccine. Additionally, CEPI is backing two other candidates based on recombinant vesicular stomatitis virus technology. One is developed by IAVI with manufacturing led by Hilleman Laboratories, while the other is produced by Public Health Vaccines. None of these candidates have yet gained regulatory approval for widespread use. WHO emphasizes that ongoing surveillance, rapid diagnosis, patient management, safe burial practices, and community engagement are vital to controlling the outbreak.