Moderna’s mRNA-1469 Recommended for Conditional Phase 2/3 Ebola Vaccine Study
Moderna said mRNA-1469 has been recommended for inclusion in the Phase 2/3 Tumaini efficacy study in the Democratic Republic of the Congo, subject to regulatory approval.
Moderna, Inc. (NASDAQ:MRNA) said its investigational mRNA-1469 vaccine candidate has been recommended for inclusion in a Phase 2/3 efficacy study targeting Bundibugyo ebolavirus (BDBV). The proposed evaluation in the Democratic Republic of the Congo (DRC) remains subject to regulatory approval.
The recommendation followed an October 22 review of available evidence by the World Health Organization’s Technical Advisory Group on Candidate Vaccine Prioritization. Moderna said the evidence included preclinical findings and interim results from a Phase 1 clinical trial.
If regulatory approval is granted, mRNA-1469 will be evaluated in the Phase 2/3 Tumaini study. The study is being conducted as part of the DRC government’s response to the Bundibugyo virus disease outbreak.
Moderna reported interim results from a first-in-human Phase 1 study involving healthy adults ages 18 to 65 in Canada. The company said the candidate was generally well tolerated across all doses tested.
According to Moderna, a single dose produced robust BDBV-specific binding antibody responses. The company also cited preclinical research showing protective responses in relevant preclinical models.
Tumaini is planned as a randomized, blinded, active-controlled adaptive platform trial using a ring-vaccination approach. It is intended to assess multiple vaccine candidates, including mRNA-1469, among contacts of confirmed Bundibugyo virus disease cases.
The study is co-sponsored by the Institut National de Recherche Biomédicale and the University of Antwerp. The DRC Ministry of Health provides national leadership and oversight.
Moderna is developing mRNA-1469 through an expanded strategic collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI). CEPI has committed up to US$58.5 million to Moderna for preclinical testing, Phase 1 trials in Canada and Uganda, and the manufacture of additional clinical trial doses for Tumaini.
CEPI is also providing separate funding for the Tumaini study. Moderna said it will supply mRNA-1469 and support its clinical evaluation as part of the trial.
Moderna said it is working with CEPI, Gavi, the Vaccine Alliance, and other global health partners on procurement and supply mechanisms intended to support rapid and equitable access to mRNA-1469. Any rapid deployment to affected populations would depend on the vaccine demonstrating efficacy and receiving authorization from relevant health authorities.
Bundibugyo virus is one of four orthoebolaviruses known to cause disease in humans. Moderna said there is currently no licensed vaccine specifically indicated for the prevention of Bundibugyo virus disease.
Moderna announced that its investigational mRNA vaccine candidate mRNA-1469 has been recommended for inclusion in a Phase 2/3 efficacy study in the Democratic Republic of the Congo (DRC). The recommendation followed an October 22 review by the World Health Organization's Technical Advisory Group on Candidate Vaccine Prioritization, and remains subject to regulatory approval.
Moderna announced the recommendation on November 4, 2026. The World Health Organization's Technical Advisory Group reviewed the available evidence on October 22.
mRNA-1469 is being developed against Bundibugyo ebolavirus (BDBV), which causes Bundibugyo virus disease. Moderna said there is currently no licensed vaccine specifically indicated for preventing Bundibugyo virus disease.
The proposed Phase 2/3 Tumaini study is a randomised, blinded, active-controlled adaptive platform trial using a ring-vaccination approach. It will evaluate multiple vaccine candidates, including mRNA-1469, among contacts of confirmed Bundibugyo virus disease cases, subject to regulatory approval.
Interim results from Moderna's first-in-human Phase 1 study in healthy adults ages 18 to 65 in Canada showed that mRNA-1469 was generally well tolerated across all doses tested. A single dose generated robust BDBV-specific binding antibody responses, according to the company.
Moderna cited preclinical data showing protective responses in relevant preclinical models. The company said this supported the recommendation to advance mRNA-1469 towards the Phase 2/3 efficacy study.
The Tumaini study is being conducted as part of the DRC government's response to the Bundibugyo virus disease outbreak. It is co-sponsored by the Institut National de Recherche Biomédicale and the University of Antwerp, under the national leadership and oversight of the DRC Ministry of Health.
CEPI has committed up to US$58.5 million to Moderna for preclinical testing, Phase 1 trials in Canada and Uganda, and the manufacture of additional clinical trial doses for Tumaini. CEPI is also providing separate funding for the Tumaini study.
Moderna will supply mRNA-1469 and support its clinical evaluation as part of the Tumaini study. The company is working with CEPI, Gavi, the Vaccine Alliance, and other global health partners on the programme.
Moderna said it is working with global health partners to support rapid and equitable access to mRNA-1469, including procurement and supply mechanisms that could enable rapid deployment to affected populations. The company said this would depend on the vaccine demonstrating efficacy and receiving authorisation from relevant health authorities.
Moderna CEO Stéphane Bancel said the company now has an opportunity to evaluate whether its investigational vaccine can help protect people against Bundibugyo virus disease, citing encouraging early clinical data. He also said Moderna was grateful to CEPI, the DRC authorities, global health partners and clinical trial participants for their collaboration.
Moderna describes itself as a pioneer and leader in mRNA medicine, with an mRNA platform used to develop vaccines and therapeutics across infectious diseases, cancer, rare diseases and other areas. Its shares trade on NASDAQ under the ticker symbol MRNA, shown in the source as NASDAQ:MRNA.