NOVA SCOTIA, CANADA / RankWire.AI / – Moderna has initiated an early-phase clinical trial for a vaccine targeting Bundibugyo ebolavirus as an outbreak intensifies in the Democratic Republic of the Congo. On August 3, a volunteer in Truro, Nova Scotia, received the initial dose of the mRNA-1469 vaccine. This marks the first time the vaccine has been administered to humans. The World Health Organization has classified the outbreak in Congo as an international public health emergency.
The Phase 1 trial is set to include approximately 80 healthy adults across three sites in Canada, where investigators will assess the vaccine’s safety, tolerability, and its capacity to induce an immune response. It is important to note that this study does not aim to establish the vaccine’s effectiveness in preventing Ebola infection. Early-stage trials are primarily designed to evaluate safety and dosage parameters before progressing to larger-scale testing. The Coalition for Epidemic Preparedness Innovations has pledged up to $50 million to support testing efforts, manufacturing, and additional research doses.
WHO data through July 30 revealed 3,605 confirmed cases and 1,587 fatalities in DR Congo, with at least 651 individuals having recovered by that date. Updated statistics on August 4 showed cases surpassing 3,800 with more than 1,700 deaths. Health officials identified infections across 49 health zones in five provinces, with Ituri remaining the epicenter, responsible for roughly 88% of confirmed cases.
Outbreak underscores absence of an approved vaccine
The ongoing epidemic involves Bundibugyo ebolavirus, a distinct species within the Ebola virus family. Currently, there are no licensed vaccines or targeted treatments for this particular strain. The existing authorized Ebola vaccines are designed to combat Zaire ebolavirus, which causes a different disease form. Historically, Bundibugyo ebolavirus has triggered previous outbreaks in Uganda and DR Congo, with the country experiencing 17 Ebola outbreaks since the virus was first identified in 1976.
Transmission occurs through direct contact with blood, body fluids, organs of infected individuals, or contaminated materials. To combat the outbreak, health authorities have expanded testing, contact tracing, treatment, and infection control measures across affected regions. By July 30, officials had listed 17,863 contacts under surveillance. WHO also reported 151 confirmed cases among healthcare workers, including 44 fatalities. Ongoing armed conflict, displacement of populations, and attacks on health infrastructure have complicated efforts to access and treat patients in multiple communities.
Additional vaccine candidates progress in development
Following Moderna’s efforts, a separate Phase 1 trial was launched by the University of Oxford in the United Kingdom, with the first dose administered on July 24. The Oxford vaccine utilizes the ChAdOx1 platform, contrasting with Moderna’s messenger RNA technology. The Serum Institute of India has produced the Oxford candidate, creating a stockpile of around 620,000 doses and providing 4,000 investigational doses for research purposes.
Both programs are supported by CEPI, which is part of a broader initiative to develop vaccines specifically targeting Bundibugyo Ebola. The organization also endorses two other candidates based on recombinant vesicular stomatitis virus technology, one developed by IAVI with manufacturing led by Hilleman Laboratories, and another by Public Health Vaccines. Currently, none of these candidates has received approval for public use. WHO emphasizes that ongoing surveillance, laboratory diagnostics, patient care, safe burial practices, and community engagement continue to be vital elements of the response to the outbreak.