Global health funders have fast-tracked three investigational vaccines targeting the Bundibugyo ebolavirus amid an active outbreak in Africa. Moderna has initiated a Phase I clinical trial for its mRNA-1469 candidate in Canada, supported by a coalition investment of up to $50 million.
An ongoing Ebola outbreak driven by the Bundibugyo virus has prompted a coordinated push from international health agencies to accelerate countermeasure development. The Coalition for Epidemic Preparedness Innovations announced a commitment to fund three promising vaccine candidates targeting the strain, which has caused confirmed cases and suspected infections across the Democratic Republic of the Congo and Uganda.
Moderna Initiates Phase I Trial for mRNA-1469 in Canada
Moderna has officially started a first-in-human Phase I clinical trial (NCT07737717) evaluating its mRNA vaccine candidate, mRNA-1469. Approved by Health Canada, the trial takes place across three sites in Canada and enrolls approximately 80 healthy adult participants to examine the vaccine’s safety, tolerability, and immunogenicity.
The candidate utilizes the same mRNA platform that Moderna deployed during the COVID-19 pandemic. While vaccines exist for the Zaire ebolavirus strain, no approved vaccine currently protects against disease caused by the Bundibugyo variant.
“Vaccinating the first participants with mRNA-1469 marks an important milestone in advancing a vaccine candidate against Bundibugyo ebolavirus, for which no approved vaccine currently exists.”
Stéphane Bancel, CEO of Moderna
The development is backed by CEPI, which has committed up to $50m (approximately €43 million) to support preclinical testing and early-stage trials. Should Phase I data support further progression, Moderna plans to rapidly initiate Phase II and Phase III studies. As part of its agreement with CEPI, the company has also committed to making at least 500,000 doses available to low- and middle-income countries at access pricing if the vaccine is licensed.
Portfolio Expansion Adds Oxford and IAIVI Candidates
Alongside the Moderna project, global health funders are advancing two additional vaccine candidates identified by the World Health Organization as the most promising ones currently under development to combat Ebola. The University of Oxford and the Serum Institute of India will receive an initial allocation of up to $8.6 million (about €7.4 million) for preclinical testing and development work leading up to Phase I trials, with manufacturing anchored at the Serum Institute of India.
Photo: euronews.com
Meanwhile, the International AIDS Vaccine Initiative is receiving up to $3.2 million (roughly €2.57 million) for its candidate. That formulation uses the same rVSV vaccine platform found in an already approved and WHO-prequalified vaccine against the Zaire strain of Ebola.
The current epidemiological situation has raised alarm across international bodies. The World Health Organization classified the outbreak as a Public Health Emergency of International Concern, while the Africa Centres for Disease Control and Prevention declared it a Public Health Emergency of Continental Security.
Photo: nanoappsmedical.com
“This fast-growing epidemic is already the second-largest Ebola outbreak in history, and cases are rising more quickly than they did in the 2014 – 2016 West Africa epidemic, which remains the largest on record.”
Can Africa Deliver the Next Generation of Clinical Trials? (Part 1)
Dr Richard Hatchett, CEPI’s CEO
Confirmed cases have surpassed 3,000 in reporting cited by NanoApps Medical, alongside more than 1,400 deaths, while reporting monitored by Euronews noted at least 282 confirmed cases and some 1,000 suspected cases recorded in the Democratic Republic of the Congo. While vaccine trials advance, the WHO emphasizes that stopping transmission relies on established public health tools, including disease surveillance, rapid testing and diagnosis, contact tracing, isolation and care for patients, infection prevention and control, community engagement, and safe and dignified burials.
Simultaneously, the Africa CDC and CEPI published a comprehensive database detailing 45 African clinical trial units across 17 countries to bolster local research infrastructure. Dr Jean Kaseya, Director-General of Africa CDC, emphasized that the continent possesses the scientific expertise, infrastructure and leadership necessary to drive vaccine research and build sustainable R&D and vaccine manufacturing capacity.
Barriers to global oncology clinical trial participation in sub-Saharan Africa
