Abuja: The Coalition for Epidemic Preparedness Innovations (CEPI) has announced the commencement of the world’s first human clinical trial of a vaccine against the Bundibugyo strain of the Ebola virus, with the first volunteer successfully vaccinated at the University of Oxford.
According to News Agency of Nigeria, the Phase I trial, known as BD-Ebov, will assess the safety of the experimental vaccine and its ability to generate immune responses in healthy adult volunteers. The vaccine candidate, ChAdOx1 BDBV, was developed by scientists at the University of Oxford’s Oxford Vaccine Group and the Pandemic Sciences Institute using the same adenoviral vector technology employed in the Oxford/AstraZeneca COVID-19 vaccine.
The announcement marks the first time the ChAdOx1 BDBV vaccine has been administered to humans. The vaccine development programme has progressed rapidly through collaboration among the University of Oxford, its Clinical BioManufacturing Facility, the Serum Institute of India (SII), and CEPI. SII manufactured the vaccine candidate in record time and has stockpiled approximately 620,000 doses, while providing 4,000 investigational doses for the ongoing clinical trial.
CEPI stated that the trial forms part of an 8.6 million U.S. dollar programme supporting the University of Oxford and SII to accelerate the development of a vaccine against the Bundibugyo ebolavirus. The trial arrives as the Democratic Republic of the Congo (DRC) battles a severe outbreak of Bundibugyo Ebola Virus Disease, with more than 2,500 confirmed cases and over 1,000 deaths recorded.
Unlike the Zaire strain of Ebola, for which licensed vaccines are available, there is currently no approved vaccine specifically targeting the Bundibugyo strain. Dr David Pulido-Gomez, Global Chemistry, Manufacturing and Controls Lead at the Pandemic Sciences Institute, emphasized the rapid progression from concept to clinical evaluation within just eight weeks.
Dr Peter Skydmore, Lead Study Doctor, described the vaccination of the first participant as a significant milestone and an important first step in evaluating the vaccine in humans. Over the coming months, the team will continue vaccinating and monitoring participants while assessing the vaccine’s safety and immune responses.
Chief Investigator, Dr Katrina Pollock, highlighted the multinational effort to develop a vaccine against the Bundibugyo ebolavirus and commended the commitment of research partners and volunteers. Professor Teresa Lambe of the Pandemic Sciences Institute also praised the dedication of volunteers and partners, emphasizing the value of sustained investment in epidemic preparedness and vaccine research.
CEPI Chief Executive Officer, Dr Richard Hatchett, noted the urgency of developing a vaccine against the Bundibugyo strain due to the increasing cases in the DRC. The rapid work of the Oxford team to begin early-stage testing is seen as a necessary step towards developing tools to help control the outbreak.
Mr Adar Poonawalla, Chief Executive Officer of the Serum Institute of India, highlighted the rapid manufacture of the vaccine candidate as a demonstration of how scientific innovation and scalable production can accelerate responses to emerging infectious diseases. He reaffirmed the institute’s commitment to supporting equitable access to vaccines for populations most at risk.
Recruitment and vaccination of additional volunteers will continue in the coming weeks, with preparations underway for further clinical studies in Uganda, subject to regulatory approval. If the Phase I trial demonstrates favourable safety and immune responses, CEPI, the University of Oxford, and SII plan to advance to larger late-stage studies to support emergency use authorisation or full regulatory approval.
ChAdOx1 BDBV is an experimental vaccine developed specifically to protect against the Bundibugyo strain of the Ebola virus. It uses the ChAdOx1 platform, a harmless chimpanzee adenovirus vector engineered to carry genetic material from the Bundibugyo ebolavirus, training the body’s immune system to recognise and fight the virus without causing Ebola infection.
Researchers believe that the Phase I trial will evaluate the vaccine’s safety and its ability to stimulate an immune response in healthy volunteers, potentially paving the way for larger trials to determine its efficacy before it can be considered for emergency use authorisation or full licensure.