First Human Trial of Ebola Vaccine Begins

The Coalition for Epidemic Preparedness Innovations (CEPI) has kicked off the world's first human clinical trial of a vaccine made for the Bundibugyo strain of the Ebola virus. The first volunteer got vaccinated at the University of Oxford.

CEPI's Senior Communications and Advocacy Manager, Jodie Rogers, shared the announcement in a statement to the News Agency of Nigeria (NAN) on Friday.

This Phase I clinical trial, called BD-Ebov, will check how safe the vaccine is and how well it can trigger immune responses in healthy adults.

The vaccine candidate, ChAdOx1 BDBV, was created by scientists at the Oxford Vaccine Group and the Pandemic Sciences Institute. They used the same adenoviral vector technology that was also used in the Oxford/AstraZeneca COVID-19 vaccine.

The statement mentioned that this milestone comes just a few weeks after the BD-Ebov study started. It also marks the first time this vaccine has been given to humans.

The vaccine development moved quickly thanks to teamwork between the University of Oxford, its Clinical BioManufacturing Facility, the Serum Institute of India (SII), and CEPI. The SII made the vaccine candidate in record time and has stockpiled about 620,000 doses. They also provided 4,000 doses for the ongoing trial.

CEPI noted that the trial is part of an $8.6 million program to help the University of Oxford and SII speed up the development of a vaccine against the Bundibugyo strain.

NAN reports that this trial comes as the Democratic Republic of the Congo (DRC) faces a serious outbreak of Bundibugyo Ebola Virus Disease. There have been more than 2,500 confirmed cases and over 1,000 deaths.

Unlike the Zaire strain of Ebola, there is no approved vaccine that specifically targets the Bundibugyo strain.

David Pulido-Gomez, who leads Global Chemistry, Manufacturing, and Controls at the Pandemic Sciences Institute, said the vaccine candidate went from idea to clinical evaluation in just eight weeks. He said, "Reaching this milestone in such a short timeframe reflects an extraordinary collaborative effort."

He added, "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."

The Lead Study Doctor, Peter Skydmore, called the vaccination of the first participant a big milestone. He said that while these are early days, they mark an important step in checking 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 Katrina Pollock said starting this trial is another key phase in the multinational effort to make a vaccine against the Bundibugyo ebolavirus. She praised the commitment of research partners and volunteers, saying their involvement is vital in responding to the ongoing outbreak.

CEPI's Chief Executive Officer, Richard Hatchett, commented on the situation. He said the worsening outbreak in the DRC shows how urgent it is to develop a vaccine against the Bundibugyo strain. He stated, "With Bundibugyo cases increasing at a concerning rate in the DRC, this epidemic shows no signs of stopping."

Adar Poonawalla, CEO of SII, said the quick making of the vaccine candidate shows how scientific innovation and large-scale production can speed up responses to new infectious diseases. He promised that the institute remains committed to ensuring fair access to vaccines for those most at risk.

The statement added that recruiting and vaccinating more volunteers will continue in the coming weeks. They are also preparing for further clinical studies in Uganda, pending regulatory approval.

If Phase I shows good safety and immune responses, CEPI, the University of Oxford, and SII will move to larger studies for emergency use authorisation or full regulatory approval.

The partners also pledged to ensure that the vaccine will be supplied quickly, affordably, and fairly to affected countries once it is developed successfully.

NAN reports that ChAdOx1 BDBV is an experimental vaccine aimed at protecting against the Bundibugyo strain, one of the types that causes Ebola Virus Disease. This vaccine uses the ChAdOx1 platform, which is a harmless chimpanzee adenovirus vector designed to carry genetic material from the Bundibugyo ebolavirus. This method helps the body's immune system learn to recognize and fight the virus without causing Ebola infection. The same technology was used for the Oxford/AstraZeneca COVID-19 vaccine, which was used worldwide during the pandemic. Researchers say this existing platform helped in quickly developing the Bundibugyo vaccine candidate.