The University of Oxford has launched the world’s first human clinical trial of a vaccine targeting the Bundibugyo ebolavirus (BDBV), marking a significant step in efforts to contain the ongoing Ebola outbreak affecting parts of Uganda and the Democratic Republic of Congo (DRC).
The early-stage study, named BD-Ebov, will assess the safety and immune response of the ChAdOx1 BDBV vaccine in 50 healthy volunteers aged 18 to 55 in Oxford. Recruitment has already begun, while vaccinations are expected to start in the coming weeks, subject to regulatory approval.
The experimental vaccine was developed by researchers at Oxford’s Vaccine Group and Pandemic Sciences Institute using the same chimpanzee adenovirus (ChAdOx1) platform that powered the widely used Oxford/AstraZeneca COVID-19 vaccine.
The Serum Institute of India (SII), the world’s largest vaccine manufacturer, is partnering on the project. The company said it produced and stockpiled around 620,000 doses of the vaccine candidate within two weeks and has already supplied 4,000 investigational doses for the Phase I trial.
The trial follows the World Health Organization’s (WHO) recommendation in May to prioritize the ChAdOx1 BDBV vaccine, alongside the rVSV Bundibugyo vaccine candidate being developed by the International AIDS Vaccine Initiative (IAVI), for clinical evaluation during the current outbreak.
The Coalition for Epidemic Preparedness Innovations (CEPI) has committed up to $8.6 million to support the vaccine’s development and future testing.
Preparations are also underway for additional clinical trials in Uganda through partnerships with the Medical Research Council/Uganda Virus Research Institute and the London School of Hygiene and Tropical Medicine Uganda Research Unit, pending local regulatory approvals.
If the Phase I trial demonstrates strong safety and immune responses, Oxford, CEPI, and the Serum Institute plan to advance the vaccine into larger late-stage studies to seek emergency-use authorization or full regulatory approval. The partners say their goal is to ensure rapid, affordable access to the vaccine for countries most vulnerable to future Bundibugyo Ebola outbreaks.