Moderna's experimental Ebola vaccine is set to advance to a Phase 2/3 efficacy trial in the Democratic Republic of the Congo (DRC), marking a significant step in efforts to combat the deadly Bundibugyo virus disease outbreak.

 

The company's investigational mRNA vaccine candidate, mRNA-1469, has been recommended for inclusion in the Phase 2/3 Tumaini study following encouraging preclinical findings and early clinical results. 

 

The recommendation was made after the World Health Organization's Technical Advisory Group on Candidate Vaccine Prioritization (TAG-CVP) reviewed the available evidence on October 22.

 

Subject to regulatory approval, the vaccine will be evaluated as part of the DRC government's outbreak response, potentially bringing researchers closer to determining whether an mRNA-based vaccine can protect people against Bundibugyo ebolavirus (BDBV).

 

"The ability to rapidly develop and advance vaccine candidates against emerging infectious diseases is an important part of the promise of mRNA technology," said Stéphane Bancel, Chief Executive Officer of Moderna. 

 

"With encouraging early clinical data, we now have an opportunity to evaluate whether our investigational vaccine can help protect people against Bundibugyo virus disease. We are grateful to CEPI, the DRC authorities and our global health partners and clinical trial participants for their collaboration in advancing this important work."

 

The recommendation follows promising early findings from Moderna's first-in-human Phase 1 trial involving healthy adults aged 18 to 65 in Canada. Interim results showed that mRNA-1469 was generally well tolerated across all doses tested, with a single dose generating robust BDBV-specific binding antibody responses.

 

The clinical findings build on encouraging preclinical data, which demonstrated protective immune responses in relevant animal models.

 

Moderna is developing mRNA-1469 through its expanded strategic partnership with the Coalition for Epidemic Preparedness Innovations (CEPI), which has committed up to US$58.5 million to support preclinical testing, Phase 1 trials in Canada and Uganda, and the manufacture of additional clinical trial doses for the Tumaini study.

 

CEPI is also providing separate funding for the Tumaini trial. Moderna will supply the investigational vaccine and support its clinical evaluation.

 

"Safe and effective vaccines are urgently needed to help bring the devastating outbreak in the DRC under control. Our longstanding partnership with Moderna and the company's dedication to meeting this challenge enabled the vaccine candidate to move rapidly into clinical trials, and the recommendation from WHO's technical advisory group to include it in the Tumaini study is an important milestone," said Richard Hatchett, CEO of CEPI. 

 

"It brings us a step closer to finding out, as quickly as possible, whether BDBV-specific vaccines can protect people against this disease and, if they can, getting them to the communities that need them most."

 

The Phase 2/3 Tumaini study will use a randomized, blinded, active-controlled adaptive platform design to assess multiple vaccine candidates, including mRNA-1469.

 

The trial will employ a ring-vaccination approach, targeting contacts of confirmed Bundibugyo virus disease cases. This strategy is designed to help researchers evaluate vaccine performance among people who may have been exposed to the virus.

 

The study is co-sponsored by the Institut National de Recherche Biomédicale (INRB) and the University of Antwerp, under the national leadership and oversight of the DRC Ministry of Health.

 

Beyond clinical development, Moderna is working with CEPI, Gavi, the Vaccine Alliance, and other global health partners to establish mechanisms for rapid and equitable access to mRNA-1469.

 

These efforts include developing procurement and supply arrangements that could support swift vaccine deployment to affected communities if the candidate demonstrates efficacy and receives authorization from the relevant health authorities.

 

Bundibugyo virus is one of four orthoebolaviruses known to cause disease in humans. Despite the serious public health threat posed by the virus, no vaccine is currently licensed specifically to prevent Bundibugyo virus disease.

 

The planned Phase 2/3 trial will therefore be a critical step in determining whether Moderna's experimental vaccine can help address a significant gap in the global response to Ebola-related outbreaks.