First trial of Bundibugyo Ebola vaccine starts in UK
Gani Nurhakim
The University of Oxford has launched what it says is the world's first phase I clinical trial of a vaccine specifically designed to protect against the Bundibugyo Ebola virus (BDBV) currently causing an outbreak in central Africa.
The BD-Ebov study, which is being run by the university's Oxford Vaccine Group, is testing the ChAdOx1 BDBV shot in 50 healthy adults aged 18–55 years, with recruitment now underway and dosing waiting for approval from the UK medicines regulator.
The start of the trial comes just eight weeks after scientists in the group first started developing a BDBV candidate, around the same time as the current Ebola outbreak in the Democratic Republic of the Congo and Uganda was declared a public health emergency by the WHO. It is based on the same viral vector platform as the Oxford/AstraZeneca COVID-19 vaccine, which was an important factor in resolving the 2020-2023 pandemic.
The outbreak is one of the largest recorded, with 1,792 confirmed cases and a death toll currently recorded at 625. The latest outbreak is particularly challenging because it involves a rare species of Ebola for which there is currently no vaccine, while the region affected is fairly remote and affected by conflict.
Bundibugyo is one of four species of Ebolavirus that are known to infect humans, but is thought to be responsible for only two of more than 40 outbreaks recorded since the 1970s.
Serum Institute of India (SII) is partnering with Oxford University on the ChAdOx1 BDBV programme, as it did with the COVID-19 shot. The company said it had manufactured and stockpiled about 620,000 doses of the vaccine candidate within two weeks and has supplied 4,000 investigational doses for the phase 1 study.
In May, the WHO named ChAdOx1 BDBV and a single-dose rVSV Bundibugyo vaccine being developed by the International AIDS Vaccine Initiative (IAVI) as the most promising candidates for clinical testing.
Funding for the trial is being provided by the Coalition for Epidemic Preparedness Innovations (CEPI), which has made $60 million available for trials of BDBV vaccines. The bulk of that ($50 million) is earmarked for an mRNA vaccine being developed by Moderna, with ChAdOx1 BDBV in line for $8.6 million and the rVSV candidate allocated $3.2 million.
"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," said Prof Katrina Pollock, chief investigator at the Oxford Vaccine Group.
"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," she added.
Photo by Gani Nurhakim on Unsplash
