Oxford begins first human trial of Bundibugyo Ebola vaccine

The Oxford Vaccine Group has begun the world's first Phase I clinical trial of a vaccine against the Bundibugyo strain of the Ebola virus, according to a joint statement issued by the University of Oxford and the Serum Institute of India (SII) on Monday.

The first-in-human trial, BD-Ebov, will assess the safety, tolerability and immune responses of the ChAdOx1 BDBV vaccine candidate, which is based on the same technology used in the Oxford/AstraZeneca covid-19 vaccine.

The human trial began 57 days after the World Health Organization declared the Bundibugyo Ebola outbreak a public health emergency of international concern.

The evaluation involves 50 healthy adult participants aged 18 to 55 years. Volunteer recruitment is currently active, with individuals undergoing screening visits prior to vaccination and mandatory clinical follow-up periods, the statement said.

The SII has supported the trial by manufacturing and stockpiling about 620,000 doses of the vaccine candidate in two weeks for potential future use, while supplying 4,000 investigational doses for the Phase I study.

This initiative is financed through an $8.6 million programme from the Coalition for Epidemic Preparedness Innovations (CEPI) to the University of Oxford and the SII, following the SII's participation in the coalition's Vaccine Manufacturing Facility Network.

“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 the CEPI, the University of Oxford and other partners,” said Adar Poonawalla, chief executive of the SII.

Third-largest Ebola outbreak

The active global outbreak of the Bundibugyo ebolavirus strain has resulted in 1,873 confirmed cases and 672 deaths in the Democratic Republic of the Congo, alongside 20 confirmed cases and two deaths in Uganda. It is already the third-largest Ebola outbreak on record.

India has initiated enhanced screening and surveillance measures at international airports and entry points to maintain public health preparedness against the virus.

Meanwhile, preparations are ongoing for subsequent clinical assessments in collaboration with the Medical Research Council/Uganda Virus Research Institute and the London School of Hygiene and Tropical Medicine Uganda Research Unit.

“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,” said Teresa Lambe OBE, Calleva head of immunology at the Oxford Vaccine Group and Pandemic Sciences Institute.

Katrina Pollock, an MRC clinician-scientist in vaccinology and chief investigator at the Oxford Vaccine Group, added that 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.