Oxford Launches First Phase I Bundibugyo Ebola Vaccine Trial

The University of Oxford’s Oxford Vaccine Group (OVG) has launched the world’s first Phase I clinical trial, BD-Ebov, evaluating a vaccine candidate specifically developed against Bundibugyo ebolavirus (BDBV). The study, initiated in response to the ongoing outbreak in the Democratic Republic of the Congo and neighboring Uganda, marks an important milestone in efforts to develop a preventive vaccine against this Ebola virus species. The investigational ChAdOx1 BDBV vaccine was developed by scientists at the Oxford Vaccine Group and the Pandemic Sciences Institute using the same ChAdOx viral vector platform employed in the Oxford-AstraZeneca COVID-19 vaccine.

Trial Design and Regulatory Status

The Phase I trial will be conducted in Oxford, United Kingdom, to evaluate the safety, tolerability, and immune response of the ChAdOx1 BDBV vaccine in 50 healthy adults aged 18 to 55 years. Volunteer recruitment is currently underway, with participants undergoing screening before vaccination and scheduled follow-up visits after immunization.

The study has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA), enabling the first-in-human evaluation of the vaccine candidate. The primary objectives are to assess the vaccine’s safety and tolerability, while immunogenicity, or its ability to generate an immune response, will serve as a key secondary objective. Although no interim analysis timeline has been announced, the study is expected to generate data that will guide future clinical development.

Vaccine Development and Manufacturing

To support rapid clinical evaluation, the Serum Institute of India (SII) manufactured and stockpiled approximately 620,000 doses of the ChAdOx1 BDBV vaccine within two weeks for potential future outbreak response. The company has also supplied 4,000 investigational doses for use in the Phase I study.

The vaccine is based on Oxford’s well-established ChAdOx viral vector platform, which previously formed the basis of the Oxford-AstraZeneca COVID-19 vaccine that is estimated to have saved more than six million lives during its first year of global use. Leveraging this established technology could accelerate clinical development while providing a familiar manufacturing platform for large-scale vaccine production if future studies prove successful.

Funding and Future Development

The program is supported by the Coalition for Epidemic Preparedness Innovations (CEPI) through an US$8.6 million funding initiative awarded to the University of Oxford and SII. The initiative builds on CEPI’s long-standing partnership with Oxford and SII’s participation in CEPI’s Vaccine Manufacturing Facility Network.

Preparations are also underway for additional clinical studies, subject to regulatory approvals, in collaboration with the Medical Research Council/Uganda Virus Research Institute and the London School of Hygiene and Tropical Medicine Uganda Research Unit. If Phase I results are favorable, CEPI expects to support later-stage clinical trials aimed at generating evidence for potential emergency use authorization or full licensure.

Expert Perspectives

Professor Teresa Lambe, Calleva Head of Immunology at the Oxford Vaccine Group and the Pandemic Sciences Institute and Lead Scientific Investigator of the study, said the ongoing Bundibugyo outbreak highlights the urgent need for effective vaccines and treatments. She noted that the candidate vaccine was developed through close collaboration among international partners and that the trial reached this milestone only 57 days after the World Health Organization declared the outbreak a Public Health Emergency of International Concern (PHEIC).

Professor Katrina Pollock, Chief Investigator at the Oxford Vaccine Group, described the launch of the first-in-human study as the culmination of extensive work across vaccine development, manufacturing, and clinical testing teams. She emphasized that the trial will generate critical safety and immunogenicity data while thanking volunteers for supporting the research.

Dr. Nicole Lurie, Executive Director of Preparedness and Response at CEPI, said the current Bundibugyo epidemic is already the third-largest Ebola outbreak on record and that rapidly advancing the vaccine into human testing represents a critical step toward strengthening outbreak preparedness.

Adar Poonawalla, Chief Executive Officer of Serum Institute of India, highlighted the importance of rapid manufacturing capacity and global collaboration during infectious disease outbreaks. He reaffirmed SII’s commitment to supporting the program and ensuring affordable vaccine access for countries affected by future Bundibugyo outbreaks.

Dr. Jean Kaseya, Director General of the Africa Centres for Disease Control and Prevention (Africa CDC), welcomed the trial as an important advance for outbreak preparedness while emphasizing that innovation should remain aligned with African priorities, community trust, and equitable access.

What This Means to Patients

Although the ChAdOx1 BDBV vaccine is still in early-stage clinical testing and is not yet available for public use, the BD-Ebov trial represents an important first step toward developing protection against Bundibugyo ebolavirus. If the vaccine demonstrates an acceptable safety profile and generates a strong immune response, it could advance into larger clinical trials and eventually support emergency use during future Ebola outbreaks. The study also demonstrates how rapid scientific collaboration, regulatory support, and global manufacturing partnerships can accelerate the development of vaccines for emerging infectious diseases.

Reference

World’s first Phase I Bundibugyo ebolavirus vaccine trial launched by Oxford Vaccine Group | Oxford University