First participant vaccinated in pivotal Phase 2/3 Bundibugyo vaccine trial in DRC

Picture: WHO/Dany Bitita

• Tumaini, a pivotal Phase 2/3 clinical trial, will evaluate vaccine candidates including Ervebo as part of the Democratic Republic of the Congo’s (DRC) outbreak response.

• There is currently no approved vaccine against Bundibugyo virus. Tumaini aims to close that gap by generating robust evidence about the performance of multiple vaccine candidates.

Prof Hugo Kavunga, Tumaini Co-Sponsor and Principal Investigator, Institut National de Recherche Biomédicale, said: “Vaccinating the first participant is an important milestone, made possible by the dedication of Congolese researchers, health workers and our partners. With affected communities at the heart of this effort, we are placing national scientific leadership at the service of the outbreak response. Our priority is to establish which vaccines can safely and effectively protect those at risk.”

Prof Jean-Pierre Van geertruyden, Tumaini Co-Sponsor and Co-Principal Investigator, University of Antwerp, said: “During an outbreak, speed and scientific rigour must go hand in hand. Tumaini brings together Congolese and international expertise to generate reliable evidence on vaccines against Bundibugyo virus. Through this partnership, we aim to support the response today while building the knowledge needed to protect communities in future outbreaks.”

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. 

Through the R&D Blueprint, WHO has developed protocols for filovirus vaccine studies that were adapted rapidly for the Tumaini trial. WHO provides leadership in the BVD response supporting the Ministry of Health of the DRC. For the Tumaini trial, WHO provides strategic, technical and scientific advice along with on-the-ground experience to stand up a vaccine trial embedded in an emergency response.

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. Partners including Epicentre, Médecins Sans Frontières (MSF), the Institute of Tropical Medicine Antwerp (ITM), WHO and Africa CDC support implementation of the trial. MSF uses the organisation’s own funding and operational capacity to support the trial. 

Tumaini is funded by CEPI’s Bundibugyo virus vaccine development programme, which, to date, is backed by the European Commission, the U.S. Department of State, the Fund for Science and Technology, the Republic of Korea and CEPI’s core funding. Beyond the trial, Tumaini is part of a broader “push–pull” partnership between CEPI and Gavi, the Vaccine Alliance, in which Gavi has committed up to US$40 million to fund manufacturing readiness to ensure vaccines are available at scale as soon as they are approved for deployment.

Dr Richard Hatchett, CEO of CEPI, said: “There is still no licensed vaccine against Bundibugyo virus, and the cost of that absence is being counted in the DRC every day, in lives lost and in health workers who go to work without protection. Tumaini aims to change that. Today’s first vaccination opens a pivotal trial to generate the evidence needed to get safe and effective vaccines to the people who need them most.”

Dr Chikwe Ihekweazu, Executive Director, Health Emergencies Programme, World Health Organization, said: "The launch of the Tumaini trial marks a critical step towards establishing whether candidate vaccines can effectively protect people against the Bundibugyo virus. This is much more than a research study. The trial reflects WHO’s strong recommendation to evaluate candidate vaccines through well-designed research during outbreaks, using a single adaptive platform and a ring vaccination approach. This is an approach WHO and countries have used in previous outbreaks to test vaccines, including the one that is effective against Ebola virus (previously known as Zaire ebolavirus). The trial is an opportunity to generate the rigorous evidence needed to determine whether these vaccines can protect people at risk. If successful, this would be the first time we have clear evidence of vaccine efficacy against Bundibugyo virus, a major advance that could transform how we respond to this outbreak and prepare for future outbreaks and help save lives."

Prof Placide Mbala, Director of Research, Clinical Trials and Innovation at Africa CDC, said : “Tumaini means hope, and today that hope is being translated into action. At a time when our communities are facing the largest recorded Bundibugyo outbreak, this trial demonstrates the power of African-led research to address African public health challenges. This is our collective commitment to generating high-quality evidence that can save lives today while strengthening preparedness for future epidemics.”