The University of Oxford has launched a Phase I clinical trial of its ChAdOx1 BDBV vaccine candidate against the Bundibugyo strain of Ebola as the current outbreak continues to spread….reports Asian Lite News Desk
The University of Oxford has launched a Phase I clinical trial of a vaccine candidate targeting the Bundibugyo strain of Ebola, marking a key milestone in efforts to combat the ongoing outbreak that has become one of the largest on record.
The first-in-human trial, being conducted in Oxford, will evaluate the safety and immune response of the ChAdOx1 BDBV vaccine in 50 healthy adults aged between 18 and 55. Recruitment of volunteers has begun, with participants undergoing screening before receiving the vaccine following regulatory approval. They will then attend a series of follow-up visits to monitor the vaccine’s safety and effectiveness.
To support the rapid start of the trial, the Serum Institute of India (SII) has manufactured and stockpiled approximately 620,000 doses of the vaccine candidate within two weeks for potential future use. The company has also supplied 4,000 investigational doses for the Phase I study.
The programme is supported by US$8.6 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI) to the University of Oxford and SII to accelerate the development of vaccines against the Bundibugyo ebolavirus. Preparations are also underway, subject to regulatory approval, for additional clinical studies with partners including the Medical Research Council/Uganda Virus Research Institute and the London School of Hygiene and Tropical Medicine Uganda Research Unit.
The ChAdOx1 BDBV vaccine was developed by scientists at Oxford’s Oxford Vaccine Group and Pandemic Sciences Institute using the same viral vector platform as the Oxford/AstraZeneca COVID-19 vaccine.
Professor Teresa Lambe OBE, Calleva Head of Immunology at the Oxford Vaccine Group and Pandemic Sciences Institute and the study’s Lead Scientific Investigator, said the outbreak highlighted the urgent need for new vaccines.
“The ongoing Bundibugyo ebolavirus outbreak continues to devastate affected communities, underlining the urgent need for effective vaccines and treatments. Our team has worked tirelessly with global partners to develop a candidate ChAdOx BDBV vaccine, demonstrating how collaborative partnerships can enable rapid response in the face of rapidly evolving outbreaks. This milestone comes after only 57 days since the World Health Organization declared the outbreak a public health emergency of international concern,” she said.
Professor Katrina Pollock, Chief Investigator at the Oxford Vaccine Group, described the launch of the trial as an important milestone.
“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. 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 said.
She also encouraged volunteers to participate in the study, thanking previous participants for supporting vaccine research.
CEPI Executive Director for Preparedness and Response Dr Nicole Lurie said the current Bundibugyo epidemic was already the third-largest Ebola outbreak on record and continued to expand.
“The University of Oxford’s work to progress their Bundibugyo vaccine candidate ready to enter Phase I trials in a matter of weeks is a pivotal milestone in the response effort. Every step that brings a safe and effective vaccine closer helps strengthen our ability to protect vulnerable communities, save lives and bring this outbreak under control,” she said.
Serum Institute of India Chief Executive Officer Adar Poonawalla said the company was proud to support the programme by supplying investigational doses for clinical evaluation.
“We are pleased to support this important Phase I trial by supplying investigational doses of the ChAdOx1 BDBV vaccine candidate for clinical evaluation. During outbreaks, speed, preparedness and global collaboration are essential to advancing vaccine candidates quickly and responsibly. We are proud to contribute to this effort alongside CEPI, the University of Oxford and other partners,” he said.
He added that, if the Phase I trial proves successful, CEPI expects to support late-stage studies with Oxford and SII to generate data required for emergency use authorisation or full licensure. The organisations also committed to ensuring rapid and affordable access to Bundibugyo vaccines for affected countries.
Africa Centres for Disease Control and Prevention Director General Dr Jean Kaseya welcomed the start of the study, describing it as an important step in accelerating the development of safe and effective tools against the virus.
He said early-stage clinical trials would not provide an immediate solution for communities affected by the current outbreak but remained essential to strengthening preparedness for future epidemics, adding that Africa CDC would continue working with partners to ensure vaccine development aligns with African priorities and equitable access.
