CEPI-backed Bundibugyo ebolavirus vaccine trial launched by Oxford Vaccine Group

A CEPI-backed vaccine candidate developed by the University of Oxford’s Oxford Vaccine Group has become the first Bundibugyo ebolavirus vaccine to enter Phase 1 clinical trials, in a rapid response to the deadly outbreak spreading across the Democratic Republic of the Congo (DRC) and Uganda.

Conducted in Oxford, UK, the trial will assess the safety and immune response of the vaccine candidate – known as ChAdOx1 BDBV – in 50 healthy adults aged 18-55 years. Recruitment of volunteers into the study is now underway, and vaccinations are expected to begin in the coming weeks following regulatory review for trial commencement.

With the Bundibugyo emergency already the third-largest Ebola outbreak on record and infection numbers continuing to rise, Dr Nicole Lurie, Executive Director Preparedness and Response at CEPI, described the rapid progress as a pivotal milestone in the response effort.

“Every step brings a safe and effective vaccine closer and helps strengthen our ability to protect vulnerable communities, save lives and bring this outbreak under control”, Dr Lurie said.

Just two weeks after the outbreak was declared, CEPI and its long-standing partners the University of Oxford and Serum Institute of India kicked off a US$8.6 million partnership to urgently advance the development of the investigational vaccine into clinical trials.

“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”, explained Professor Teresa Lambe OBE, Calleva Head of Immunology at the Oxford Vaccine Group and Pandemic Sciences Institute, and the study’s Lead Scientific Investigator.

Head of Africa Centres for Disease Control and Prevention, Dr Jean Kaseya, welcomed the "rapid scientific progress [...] in the global effort to accelerate safe and effective tools against Bundibugyo ebolavirus."   

The ChAdOx1 BDBV vaccine was developed by scientists at the University of Oxford’s Oxford Vaccine Group and Pandemic Sciences Institute and uses the same viral vector platform as the Oxford/AstraZeneca COVID-19 vaccine, which is estimated to have saved over six million lives during its first year of use.

It is one of four initial Bundibugyo vaccine candidates in CEPI’s portfolio as the organisation seeks to advance at least two vaccines to emergency use authorisation, potentially helping to curb the outbreak and save lives. By backing multiple candidates in parallel, CEPI spreads financial risk, maximises development speed and increases the likelihood of success.

The Serum Institute of India (SII) has manufactured and stockpiled approximately620,000 doses of the ChAdOx1 BDBV vaccine candidate in two weeks for potential future use and has supplied 4,000 investigational doses for this Phase I trial.

“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” said Adar Poonawalla, CEO, Serum Institute of India. 

Subject to regulatory approval, preparations are also underway for further clinical studies with partners, including those at the Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit.

If Phase 1 trials are successful, CEPI anticipates working with the University of Oxford and SII to support late-stage trials to generate data for emergency use authorisation or licensure. 

CEPI, SII and the University of Oxford are committed to enabling rapid, affordable supply of Bundibugyo virus vaccines to affected countries and to the populations that need them.

A rapid, coordinated response

Since the declaration of the outbreak on 15th May, CEPI has rapidly mobilised human, technical, and financial resources to support R&D within nationally-led responses. 

This includes activating CEPI’s global networks of laboratories, manufacturers and clinical trial partners; supporting clinical trials to evaluate potential treatments; and engaging regulators to align on regulatory pathways. 

In parallel, CEPI is working closely with partners including affected countries, Gavi, Africa CDC, WHO, UNICEF, the World Bank and development finance institutions and implementation partners such as MSF so the downstream conditions needed to enable equitable access – including procurement, allocation and deployment – are put in place.