The world's first Phase I clinical trial of a vaccine targeting the Bundibugyo ebolavirus (BDBV) has begun at the University of Oxford.
This marks a major milestone in the global response to the ongoing Ebola outbreak in the Democratic Republic of the Congo and neighbouring Uganda.
The BD-Ebov trial, led by Oxford Vaccine Group, will evaluate the safety and immune response of the ChAdOx1 BDBV vaccine in 50 healthy volunteers aged 18 to 55. Recruitment is now underway, with participants expected to receive vaccinations in the coming weeks following regulatory approval.
In a significant boost to outbreak preparedness, Serum Institute of India (SII) manufactured and stockpiled approximately 620,000 doses of the vaccine candidate in just two weeks for potential future deployment. The company has also supplied 4,000 investigational doses for the Phase I study.
The programme is backed by an US$8.6 million grant from the Coalition for Epidemic Preparedness Innovations (CEPI), which is supporting both the University of Oxford and SII in advancing Bundibugyo vaccine development.
Additional clinical studies are also being prepared with partners, including the Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, subject to regulatory approvals.
The ChAdOx1 BDBV vaccine was developed by scientists at Oxford's Oxford Vaccine Group and Pandemic Sciences Institute using the same viral vector platform as the Oxford/AstraZeneca COVID-19 vaccine.
Professor Teresa Lambe OBE, Calleva Head of Immunology at the Oxford Vaccine Group and Pandemic Sciences Institute, and the study’s Lead Scientific Investigator, said: "The ongoing Bundibugyo ebolavirus outbreak continues to devastate affected communities, underlining the urgent need for effective vaccines and treatments.
"Our team has worked tirelessly with global partners to develop a candidate ChAdOx BDBV vaccine, demonstrating how collaborative partnerships can enable rapid response in the face of rapidly evolving outbreaks. This milestone comes after only 57 days since the World Health Organization declared the outbreak a public health emergency of international concern."
Professor Katrina Pollock, MRC Clinician Scientist in Vaccinology, and Chief Investigator at the Oxford Vaccine Group, said: "Launching this first-in-human study of a Bundibugyo ebolavirus vaccine is an important milestone for the programme and the culmination of a significant effort by teams across vaccine development, manufacturing and clinical testing.
"We are focused on delivering a rigorous Phase 1 trial, to the highest standard of care, to evaluate the safety, tolerability and immune responses generated by the vaccine. We are grateful to all participants in our studies, without whom we could not do this work. We are now inviting interested volunteers to participate in the study to support our efforts."
Nicole Lurie, Executive Director Preparedness and Response at CEPI, said: "The deadly Bundibugyo epidemic is already the third-largest Ebola outbreak on record, and infection numbers are continuing to rise.
"The University of Oxford’s work to progress their Bundibugyo vaccine candidate ready to enter Phase I trials in a matter of weeks is a pivotal milestone in the response effort. Every step that brings a safe and effective vaccine closer helps strengthen our ability to protect vulnerable communities, save lives and bring this outbreak under control."
Adar Poonawalla, CEO, SII, shared: "We are pleased to support this important Phase I trial by supplying investigational doses of the ChAdOx1 BDBV vaccine candidate for clinical evaluation. During outbreaks, speed, preparedness and global collaboration are essential to advancing vaccine candidates quickly and responsibly. We are proud to contribute to this effort alongside CEPI, the University of Oxford and other partners.
"If Phase 1 trials are successful, CEPI anticipates working with the University of Oxford and SII to support late-stage trials to generate data for emergency use authorisation or licensure.
"CEPI, SII and the University of Oxford are committed to enabling rapid, affordable supply of Bundibugyo virus vaccines to affected countries and to the populations that need them."
