Moderna starts first trial of its Bundibugyo Ebola vaccine

Moderna has started first-in-human testing of its mRNA vaccine against Bundibugyo Ebola virus (BDBV), now causing the worst-ever outbreak of the disease in the Democratic Republic of the Congo (DRC).

The first doses of the mRNA-1469 candidate have already been administered in the phase 1 trial in healthy volunteers, which is underway at three sites in Canada. It comes shortly after a study of another BDBV vaccine developed at Oxford University, ChAdOx1 BDBV, started in the UK.

There is currently no licensed vaccine or treatment for BDBV, which has now claimed more than 1,700 lives in DRC, from just over 3,800 cases, which makes it the second-largest Ebola outbreak on record, according to the World Health Organisation (WHO). This week, the UN health agency warned that the outbreak is still growing "beyond the capacity of the response."

Bundibugyo is one of four species of Ebolavirus that are known to infect humans, but is thought to be responsible for only two of more than 40 outbreaks recorded since the 1970s.

mRNA-1469 is based on the same mRNA vaccine platform that led to the creation of Moderna's Spikevax family of COVID-19 shots, which played an important role in containing the pandemic.

It is being developed under a collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI), a public-private partnership, which has committed up to $50 million to support preclinical testing and the phase 1 trial. It will also help to fund the manufacture of additional clinical trial doses if mRNA-1469 moves into later-stage clinical testing.

CEPI also played a pivotal role in the hunt for vaccines against COVID-19, is also supporting the ChAdOx1 BDBV trial to the tune of $8.6 million, and stepped in to fund Moderna's pandemic flu vaccine candidate last year after the Trump administration withdrew its support.

"If licensed, Moderna is committed to enabling rapid supply and access of its BDBV vaccine to affected countries and to the populations that need them," said the company in a statement.

As part of its agreement with CEPI, it has pledged to make at least 500,000 doses available, rapidly and at affordable prices, for supply to low- and middle-income countries (LMICs).

"Getting Moderna's vaccine candidate into a phase 1 trial this rapidly is a major step forward in the fight against this deadly outbreak," said Dr Richard Hatchett, CEPI's chief executive, who noted that cases in the DRC are rising more quickly than they did in the 2014-2016 West Africa epidemic, caused by the Zaire Ebola species, which remains the largest on record.