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.
The announcement in a statement by Ms Jodie Rogers, Senior Communications and Advocacy Manager at CEPI said the milestone comes only weeks after the launch of the BD-Ebov study and marks the first time the ChAdOx1 BDBV vaccine has been administered to humans.
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.
According to the statement, the vaccine development programme had progressed rapidly through collaboration among the University of Oxford, its Clinical BioManufacturing Facility, the Serum Institute of India (SII) and CEPI.
The statement added that 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 said 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.
NAN reports that the trial comes 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, said the vaccine candidate moved from concept to clinical evaluation within just eight weeks.
“Reaching this milestone in such a short timeframe reflects an extraordinary collaborative effort.
“Working alongside colleagues at the Clinical BioManufacturing Facility and the Serum Institute of India, we have taken this vaccine candidate from concept to clinic in just eight weeks,” he said.
Lead Study Doctor, Dr Peter Skydmore, described the vaccination of the first participant as a significant milestone.
“Vaccinating the first participants in a first-in-human study is always a significant moment.
“While these are very early days, they represent an important first step in evaluating this vaccine in humans.
“Over the coming months, we will continue vaccinating and monitoring participants while assessing the vaccine’s safety and immune responses,” he said.
Chief Investigator, Dr Katrina Pollock, said the commencement of the trial marked another important phase in the multinational effort to develop a vaccine against the Bundibugyo ebolavirus.
She commended the commitment of research partners and volunteers, saying their participation was critical to responding to the ongoing outbreak.
Professor Teresa Lambe of the Pandemic Sciences Institute also praised the dedication of volunteers and partners, describing the trial as evidence of the value of sustained investment in epidemic preparedness and vaccine research.
Commenting on the development, CEPI Chief Executive Officer, Dr Richard Hatchett, said the worsening outbreak in the DRC underscored the urgency of developing a vaccine against the Bundibugyo strain.
“With Bundibugyo cases increasing at a concerning rate in the DRC, this epidemic shows no signs of stopping.
“The need for a vaccine against this specific Ebolavirus becomes more urgent every day.
“The rapid work of the Oxford team to begin early-stage testing of their vaccine is a much-needed step towards developing the tools that could help bring this outbreak to an end,” Hatchett said.
Also speaking, Chief Executive Officer of the Serum Institute of India, Mr Adar Poonawalla, said the rapid manufacture of the vaccine candidate demonstrated how scientific innovation and scalable production could accelerate responses to emerging infectious diseases.
He reaffirmed the institute’s commitment to supporting equitable access to vaccines for populations most at risk.
According to the statement, recruitment and vaccination of additional volunteers will continue over the coming weeks, while preparations are underway, subject to regulatory approval, for further clinical studies in Uganda.
It added that if the Phase I trial demonstrates favourable safety and immune responses, CEPI, the University of Oxford and SII will advance to larger late-stage studies to support emergency use authorisation or full regulatory approval.
The partners also pledged to ensure the rapid, affordable and equitable supply of the vaccine to affected countries once it is successfully developed.
NAN reports that ChAdOx1 BDBV is an experimental vaccine developed specifically to protect against the Bundibugyo strain of the Ebola virus, one of the species that causes Ebola Virus Disease.
The vaccine uses the ChAdOx1 platform, a harmless chimpanzee adenovirus vector engineered to carry genetic material from the Bundibugyo ebolavirus.
The technology trains the body’s immune system to recognise and fight the virus without causing Ebola infection.
The same ChAdOx1 platform was used to develop the Oxford/AstraZeneca COVID-19 vaccine, which was deployed globally during the COVID-19 pandemic.
Researchers say the existing platform enabled the rapid development of the Bundibugyo vaccine candidate.
Unlike currently licensed Ebola vaccines, which target the Zaire strain of the virus, ChAdOx1 BDBV is the first vaccine designed specifically against the Bundibugyo ebolavirus.
Scientists believe it could fill a critical gap in global preparedness if it proves safe and effective.
According to researchers, the Phase I trial is intended to evaluate the vaccine’s safety and its ability to stimulate an immune response in healthy volunteers.Successful completion of this phase would pave the way for larger trials to determine how well the vaccine protects against infection before it can be considered for emergency use authorisation or full licensure.
