Final preparations are underway for a clinical trial whose very name speaks to the people it is meant to serve. Tumaini, which means “hope” in Swahili, is a pivotal Phase 2/3 study that will evaluate vaccine candidates against Bundibugyo virus, including Ervebo, a vaccine already licensed to prevent Ebola virus disease. No approved vaccine against Bundibugyo virus exists today. The trial is designed to help close that gap as communities in the Democratic Republic of the Congo (DRC) live through an ongoing outbreak.
Subject to ethical and regulatory approval, the trial is expected to begin in the coming weeks. It will assess the safety, immunogenicity and efficacy of the vaccine candidates and will support the Government-led response to the outbreak, putting an experimental tool in the hands of the response teams working to protect people at risk.
The people steering the effort sit close to the outbreak itself. The trial is led and co-sponsored by the Institut National de Recherche Biomédicale (INRB) and the University of Antwerp’s Global Health Institute, while the DRC Ministry of Health provides national leadership and oversight. The Trial Steering Committee is chaired by the Ministry’s Incident Response Manager and provides strategic oversight, ensuring the study stays closely aligned with the wider outbreak response and with other studies of medical countermeasures in the region.
African-led research sits at the centre of the design. Africa CDC plays a strategic role in advancing that agenda, strengthening regional coordination, ensuring that emerging scientific evidence informs public health decision-making and the wider Ebola outbreak response, and supporting timely and equitable access to successful vaccine candidates. The World Health Organization (WHO) provides strategic, technical and scientific advice.
For communities in the outbreak zone, the shape of the trial matters as much as its science. Tumaini is designed as an adaptive platform trial, again subject to ethical and regulatory approval, meaning several vaccine candidates can be evaluated in parallel within a single framework. That approach saves valuable time during an outbreak, when every week can change who is exposed. Candidates will be assessed through ring vaccination, a method that focuses on the contacts at highest risk of infection rather than the wider population. Technical details are available on ClinicalTrials.gov (NCT07842107).
Which vaccines actually reach the field will be decided through an independent prioritisation process led by the WHO Technical Advisory Group on Candidate Vaccine Prioritisation (TAG-CVP). The group has recommended that Ervebo be prioritised for evaluation in a Phase 3 clinical trial, with Bundibugyo-specific candidates entering the study as soon as they become available. Ervebo is likely to be the first vaccine to enter the trial. Two Bundibugyo-specific candidates, one under development by Moderna and another by the University of Oxford in collaboration with Serum Institute of India, are currently in Phase 1 trials.
Meanwhile, behind the scenes, a broad set of partners is working to make the trial happen. Epicentre, Médecins Sans Frontières (MSF), the Institute of Tropical Medicine Antwerp (ITM), WHO and Africa CDC support implementation. MSF brings its own funding and operational capacity to the effort. CEPI provides funding, scientific expertise and operational support, and is backing a portfolio of Bundibugyo-specific vaccine candidates that could be evaluated in the study.
The trial is funded through CEPI’s Bundibugyo virus vaccine development programme. To date, that programme is backed by the European Commission, the U.S. Department of State, the Fund for Science and Technology, and CEPI’s core funding.
For the people living under the shadow of the outbreak, the hope embedded in the trial’s name is now a matter of weeks away, pending the approvals that will allow it to begin.