The Coalition for Epidemic Preparedness Innovations (CEPI) says the first participant has been dosed in a phase one clinical trial of Moderna’s investigational vaccine against Bundibugyo ebolavirus.

The trial marks a significant step in efforts to develop a vaccine against the virus driving the ongoing Ebola outbreak in the Democratic Republic of the Congo (DRC).

CEPI on Tuesday said the first-in-human trial was being conducted at three sites in Canada.

It said that the purpose of the trial was to assess the safety and tolerability of Moderna’s mRNA-1469 vaccine in healthy adult volunteers and evaluate the immune response it generates.

According to the coalition, the trial comes amid a worsening Ebola outbreak in the DRC, where more than 3,800 people have been infected, and over 1,700 have died.

It said that the World Health Organisation (WHO) declared the outbreak a Public Health Emergency of International Concern on May 17, describing it as the second-largest Ebola outbreak in history.

CEPI said the outbreak had exposed a critical gap in global Ebola preparedness, noting that while licensed vaccines exist for Zaire ebolavirus, no approved vaccine is currently available against Bundibugyo ebolavirus.

The coalition said the Canadian study would enrol about 80 healthy adult volunteers to determine whether the vaccine is safe, well tolerated and capable of generating immune responses that will justify further clinical development.

It said that the investigational vaccine was developed using Moderna’s messenger RNA (mRNA) platform, the same technology deployed in the company’s COVID-19 vaccine.

CEPI said it had committed up to $50 million to support pre-clinical studies, the phase one clinical trial and the manufacture of additional clinical trial doses in parallel with early-stage testing.

It said the investment was intended to enable larger efficacy trials to begin quickly if the phase one study demonstrated promising safety and immune response results.

The coalition said that, if licensed, Moderna had committed to ensuring rapid access to the vaccine for affected countries.

It said the company would make available a minimum of 500,000 doses for timely supply to low- and middle-income countries under access pricing arrangements.

Richard Hatchett, chief executive officer of CEPI, described the commencement of the clinical trial as a significant step in the global response to the outbreak.

“Getting Moderna’s vaccine candidate into a Phase 1 trial this rapidly is a major step forward in the fight against this deadly outbreak,” he said.

He said that every vaccine candidate entering clinical trials increased the chances of rapidly developing a safe and effective vaccine for populations most at risk.

“Moderna’s mRNA-1469 is one of four Bundibugyo Ebola vaccine candidates being supported by CEPI under a portfolio approach designed to accelerate vaccine development,” he said.

He said the strategy involved advancing multiple experimental vaccines in parallel to improve the likelihood of identifying at least one effective vaccine capable of helping to contain the outbreak.

The CEPI boss said the other vaccine candidates included two recombinant vesicular stomatitis virus (rVSV)-based vaccines developed by IAVI, with manufacturing led by Hilleman Laboratories and Public Health Vaccines.

He said that CEPI was also supporting a vaccine candidate developed by the University of Oxford using the ChAdOx viral-vector platform and manufactured by the Serum Institute of India.

“It is already undergoing Phase 1 testing,” Mr Hatchett said.

Commenting on the milestone, Moderna Chief Executive Officer, Stéphane Bancel, said the first dosing represented an important advance in efforts to develop a vaccine against Bundibugyo ebolavirus.

“Dosing the first participant with mRNA-1469 marks an important milestone in advancing a vaccine candidate against Bundibugyo ebolavirus, for which no approved vaccine currently exists,” Mr Bancel said.

(NAN)