Moderna advances Bundibugyo ebolavirus vaccine toward Phase II/III study

Moderna is advancing its investigational mRNA vaccine against Bundibugyo ebolavirus toward a Phase II/III efficacy study following a recommendation from a World Health Organization technical advisory group.

The vaccine candidate, known as mRNA-1469, has been recommended for inclusion in the Tumaini study in the Democratic Republic of the Congo following encouraging preclinical and Phase I findings.

The recommendation was made by the WHO Technical Advisory Group on Candidate Vaccine Prioritization after reviewing available evidence on October 22.

Subject to regulatory approval, mRNA-1469 will be evaluated as part of the DRC government’s response to an outbreak of Bundibugyo virus disease.

Interim findings from Moderna’s first-in-human Phase I study showed that the investigational vaccine was generally well tolerated across all doses evaluated.

The study enrolled healthy adults aged 18 to 65 in Canada.

A single dose generated robust antibody responses specifically targeting Bundibugyo ebolavirus.

The clinical results build on preclinical findings that showed protective responses in relevant experimental models.

Stéphane Bancel, Chief Executive Officer of Moderna, said the programme demonstrates the potential of mRNA technology to support rapid vaccine development against emerging infectious diseases.

He said the next stage of clinical evaluation will assess whether mRNA-1469 can provide protection against Bundibugyo virus disease in affected communities.

The planned Phase II/III Tumaini study is a randomised, blinded, active-controlled adaptive platform trial.

It will use a ring-vaccination approach to evaluate multiple vaccine candidates among people who have been in contact with confirmed cases of Bundibugyo virus disease.

The study is being co-sponsored by the Institut National de Recherche Biomédicale and the University of Antwerp under the oversight of the DRC Ministry of Health.

Moderna is developing mRNA-1469 through an expanded strategic collaboration with the Coalition for Epidemic Preparedness Innovations.

CEPI has committed up to $58.5 million to support preclinical testing, Phase I studies in Canada and Uganda, and the manufacture of additional vaccine doses for the Tumaini trial.

The organisation is also separately funding the Phase II/III study.

Richard Hatchett, Chief Executive Officer of CEPI, said the WHO recommendation represents an important step toward determining whether vaccines specifically targeting Bundibugyo ebolavirus can protect people during an outbreak.

Moderna will provide mRNA-1469 for the study and support its clinical evaluation.

The company is also working with CEPI, Gavi, the Vaccine Alliance and other global health organisations to establish potential procurement and supply mechanisms.

These arrangements are intended to support rapid access for affected communities if the vaccine demonstrates efficacy and receives authorization from relevant health authorities.

Bundibugyo virus is one of four orthoebolaviruses known to cause disease in humans.

There is currently no licensed vaccine specifically indicated to prevent Bundibugyo virus disease.

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