- Tumaini, a pivotal Phase 2/3 clinical trial, will evaluate vaccine candidates including Ervebo as part of the DRC's outbreak response.
- There is currently no approved vaccine against Bundibugyo virus. Tumaini aims to close that gap.
Final preparations are underway for Tumaini, which means “hope” in Swahili. This pivotal Phase 2/3 clinical trial will evaluate the safety, immunogenicity and efficacy of vaccine candidates against Bundibugyo virus (BDBV), including Ervebo which is currently licensed for use to prevent Ebola virus (EBOV). The trial will support the Government-led response to the ongoing outbreak in the Democratic Republic of the Congo (DRC). Subject to ethical and regulatory approval, it is expected to begin in the coming weeks.
The Institut National de Recherche Biomédicale (INRB) and the University of Antwerp (Global Health Institute) lead and co-sponsor the Tumaini trial. The DRC Ministry of Health provides national leadership and oversight. Africa CDC plays a strategic role in advancing African-led clinical research, 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.
The Trial Steering Committee is chaired by the DRC Ministry of Health's Incident Response Manager and provides strategic oversight. This ensures the trial is closely aligned with the wider outbreak response and with other studies of medical countermeasures in the region.
Partners including Epicentre, Médecins Sans Frontières (MSF), the Institute of Tropical Medicine Antwerp (ITM), WHO and Africa CDC support implementation of the trial. CEPI provides funding, scientific expertise and operational support and is backing a portfolio of BDBV-specific vaccine candidates that could be evaluated in the study. MSF uses the organisation’s own funding and operational capacity to support the trial.
Tumaini is designed as an adaptive platform trial, subject to ethical and regulatory approval. This allows several vaccine candidates to be evaluated in parallel within a single trial framework, which saves valuable time during an outbreak. Candidates will be assessed through ring vaccination, which focuses on the contacts at high risk of infection. Technical details are available on ClinicalTrials.gov (NCT07842107).
Vaccine candidates will be selected to enter the trial through an independent prioritisation process led by the WHO Technical Advisory Group on Candidate Vaccine Prioritisation (TAG-CVP). TAG-CVP has recommended that Ervebo be prioritised for evaluation in a Phase 3 clinical trial, with BDBV-specific vaccine candidates entering the study as soon as they become available. Two such vaccine candidates, under development by Moderna; and the University of Oxford in collaboration with Serum Institute of India, are currently in Phase 1 trials. Ervebo is likely to be the first vaccine to enter the trial.
The trial is funded by CEPI’s Bundibugyo virus vaccine development programme. To date, the programme is backed by the European Commission, the U.S. Department of State, the Fund for Science and Technology, and CEPI's core funding.
CEPI statement: G7 Leaders' call for a coordinated response to the Bundibugyo ebola outbreak
CEPI statement in response to Pandemic Agreement negotiation extension
