A CEPI-backed vaccine candidate developed by the University of Oxford’s Oxford Vaccine Group has become the first Bundibugyo ebolavirus vaccine to enter Phase 1 clinical trials, in a rapid response to the deadly outbreak spreading across the Democratic Republic of the Congo (DRC) and Uganda.
Conducted in Oxford, UK, the trial will assess the safety and immune response of the vaccine candidate – known as ChAdOx1 BDBV – in 50 healthy adults aged 18-55 years.
Just two weeks after the outbreak was declared, CEPI and its long-standing partners the University of Oxford and Serum Institute of India kicked off a $8.6 million partnership to urgently advance the development of the investigational vaccine into clinical trials.
The Serum Institute of India (SII) has manufactured and stockpiled approximately 620,000 doses of the ChAdOx1 BDBV vaccine candidate in two weeks for potential future use and has supplied 4,000 investigational doses for this Phase I trial.
Subject to regulatory approval, preparations are also underway for further clinical studies with partners, including those at the Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit.
If Phase 1 trials are successful, Norway-based Coalition for Epidemic Preparedness Innovations (CEPI) anticipates working with the University of Oxford and SII to support late-stage trials to generate data for emergency use authorisation or licensure.
