Oxford begins first human trial of Bundibugyo Ebola vaccine

Oxford Vaccine Group has launched 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 study, BD-Ebov, will assess the safety, tolerability and immune response of the ChAdOx1 BDBV vaccine candidate, which is based on the same technology as 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 includes 50 healthy adult participants between the ages of 18 and 55. Volunteers are currently being recruited, with individuals undergoing pre-vaccination screening visits and mandatory clinical follow-up periods, the statement said.

SII supported the study by producing and storing about 620,000 doses of the candidate vaccine over two weeks for potential future use, while also supplying 4,000 trial doses for the Phase I study.

This initiative is funded through an $8.6 million program from the Coalition for Epidemic Preparedness Innovations (CEPI) at the University of Oxford and SII, following SII’s participation in the Coalition’s Vaccine Manufacturing Facility Network.

“During outbreaks, speed, preparedness and global collaboration are critical to the rapid and responsible progress of vaccine candidates. We are proud to contribute to this effort together with CEPI, the University of Oxford and other partners,” said Adar Poonawalla, CEO of SII.

The third largest Ebola epidemic

An active global outbreak of the Bundibugyo strain of Ebola virus has resulted in 1,873 confirmed cases and 672 deaths in the Democratic Republic of the Congo, along with 20 confirmed cases and two deaths in Uganda. This is already the third largest recorded Ebola epidemic.

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

In the meantime, preparations are underway for subsequent clinical trials 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 the ChAdOx BDBV vaccine candidate, demonstrating how collaborative collaborations can enable rapid response in the face of rapidly evolving epidemics,” said Teresa Lambe OBE, Calleva’s Head of Immunology at the Oxford Vaccine Group and Pandemic Sciences Institute.

Katrina Pollock, MRC Clinical Scientist in Vaccinology and Oxford Vaccine Group Principal Investigator, added that the launch of this first human trial of the Bundibugyo ebolavirus vaccine is an important milestone for the program and the culmination of significant efforts by teams across vaccine development, manufacturing and clinical testing.