Oxford launches first human trial of Bundibugyo Ebola vaccine as DRC outbreak intensifies

UK—The University of Oxford’s Oxford Vaccine Group has launched the world’s first Phase I clinical trial of a vaccine targeting Bundibugyo ebolavirus (BDBV), marking a significant milestone in the global response to the ongoing outbreak affecting the Democratic Republic of the Congo (DRC) and neighbouring Uganda.

The BD-Ebov trial, which is being conducted in Oxford, will evaluate the safety, tolerability and immune response of the ChAdOx1 BDBV vaccine in 50 healthy adults aged between 18 and 55 years.

Recruitment of volunteers is currently underway, with participants first attending screening appointments before receiving the vaccine following regulatory approval.

They will then return for scheduled follow-up visits to monitor their health and immune responses.

Rapid vaccine production and international collaboration

To accelerate the programme, the Serum Institute of India (SII) manufactured and stockpiled approximately 620,000 doses of the ChAdOx1 BDBV vaccine candidate within just two weeks for potential future deployment.

The company has also supplied 4,000 investigational doses for use in the Phase I study.

The programme is supported by the Coalition for Epidemic Preparedness Innovations (CEPI), which is funding the University of Oxford and SII through a US$8.6 million programme.

The initiative builds on CEPI’s long-standing collaboration with the University of Oxford and SII’s participation in the organisation’s Vaccine Manufacturing Facility Network.

Meanwhile, preparations are underway for additional clinical studies, subject to regulatory approval, in collaboration with partners including the Medical Research Council/Uganda Virus Research Institute and the London School of Hygiene and Tropical Medicine Uganda Research Unit.

Vaccine builds on proven Oxford technology

Scientists at the Oxford Vaccine Group and the University’s Pandemic Sciences Institute developed the ChAdOx1 BDBV vaccine using the same chimpanzee adenovirus vector platform that underpinned the Oxford/AstraZeneca COVID-19 vaccine, which is estimated to have saved more than six million lives during its first year of use.

Professor Teresa Lambe OBE, Calleva Head of Immunology at the Oxford Vaccine Group and Pandemic Sciences Institute and Lead Scientific Investigator for the study, said the continuing Bundibugyo outbreak highlights the urgent need for effective vaccines and treatments.

She noted that close collaboration among global partners enabled the team to develop the vaccine candidate rapidly, adding that the launch of the trial comes just 57 days after the World Health Organization declared the outbreak a Public Health Emergency of International Concern.

Partners highlight urgency of vaccine development

Professor Katrina Pollock, Chief Investigator at the Oxford Vaccine Group and MRC Clinician Scientist in Vaccinology, described the first-in-human study as the result of extensive collaboration across vaccine development, manufacturing and clinical research.

She said the team aims to conduct a rigorous Phase I trial to assess the vaccine’s safety, tolerability and ability to trigger protective immune responses while thanking volunteers for their participation and encouraging others to join the study.

Dr Nicole Lurie, Executive Director of Preparedness and Response at CEPI, said the Bundibugyo epidemic has become the third-largest Ebola outbreak on record, with infections continuing to increase.

She described the rapid progression of the Oxford vaccine candidate into human testing as a critical achievement that strengthens efforts to protect vulnerable communities and control the outbreak.

Adar Poonawalla, Chief Executive Officer of SII, said the company is proud to support the trial by supplying investigational vaccine doses.

He emphasised that rapid action, preparedness and international collaboration are essential for advancing vaccine candidates during disease outbreaks.

If the Phase I study proves successful, CEPI plans to work with Oxford and SII on late-stage clinical trials to generate data required for emergency use authorisation or full licensure while supporting rapid and affordable vaccine access in affected countries.

Dr Jean Kaseya, Director General of the Africa Centres for Disease Control and Prevention (Africa CDC), welcomed the launch of the trial as an important step toward expanding the tools available to combat Bundibugyo ebolavirus.

He said Africa CDC supports scientific innovation conducted under robust safety and regulatory standards and will continue working with Member States, the World Health Organization, CEPI and other partners to ensure vaccine development aligns with African priorities, community trust and equitable access.