The first participant has been vaccinated in a pivotal clinical trial to evaluate vaccine candidates against Bundibugyo virus in the Democratic Republic of the Congo (DRC).
The Coalition for Epidemic Preparedness Innovations (CEPI) disclosed this in a statement obtained by reporters on Friday.
The trial, named Tumaini (meaning “hope” in Swahili), will evaluate the safety, immunogenicity and efficacy of candidates, including Ervebo, against the virus.
The statement said the first vaccination was administered on Friday in Bunia, DRC, marking the start of the Phase 2/3 trial supporting the government-led outbreak response. It said the trial began as the country faced the largest recorded Bundibugyo virus outbreak and the second-largest Ebola outbreak yet.
According to the statement, the outbreak was declared on 15 May. The World Health Organization (WHO) and Africa Centres for Disease Control and Prevention (Africa CDC) subsequently declared international and continental public health emergencies.
“As of 21 October, 9,552 cases and 4,602 deaths had been confirmed in the DRC,” the statement said.
CEPI said there is currently no approved vaccine to protect against Bundibugyo virus, making the trial important for generating evidence on potential vaccines. It said the trial would use an adaptive platform design to evaluate several vaccine candidates in parallel within a single framework, helping to save time during an outbreak. Candidates would also be assessed through ring vaccination, which focuses on contacts at high risk of infection.
It added that the first candidate to enter the trial was Ervebo, which is licensed for preventing Ebola virus disease caused by the Zaire strain. Two Bundibugyo-specific candidates, funded by CEPI and being developed by Moderna and the University of Oxford in collaboration with the Serum Institute of India, are expected to enter the trial shortly.
CEPI Chief Executive Officer Dr Richard Hatchett said the absence of an approved vaccine had serious consequences for affected communities and frontline health workers.
“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,” he said. “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, WHO Executive Director for the Health Emergencies Programme, said the trial would help establish whether candidate vaccines could protect people against Bundibugyo virus.
“The launch of the Tumaini trial marks a critical step towards establishing whether candidate vaccines can effectively protect people against the Bundibugyo virus,” he said. Ihekweazu said the study reflected WHO’s recommendation to evaluate candidate vaccines through well-designed research during outbreaks, using an adaptive platform and ring vaccination approach.
“The trial is an opportunity to generate the rigorous evidence needed to determine whether these vaccines can protect people at risk,” he said. He added that successful results could provide the first clear evidence of vaccine efficacy against Bundibugyo virus and improve preparedness for future outbreaks.
The incident manager of the Ebola response in the DRC, Prof. Steve Ahuka-Mundeke, said integrating the trial into the response was important for addressing the needs of affected communities.
“Our priority is to stop transmission and save lives, while ensuring that research is closely coordinated with frontline response activities,” he said. Ahuka-Mundeke thanked participants, communities and partners whose trust and engagement made it possible to evaluate potential new tools against the virus.
Prof. Placide Mbala, Director of Research, Clinical Trials and Innovation at Africa CDC, said the trial demonstrated the role of African-led research in addressing public health challenges on the continent.
“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,” he said.
The Institut National de Recherche Biomédicale and the University of Antwerp’s Global Health Institute co-lead and co-sponsor the trial, while the DRC Ministry of Health provides national leadership and oversight. Other partners include Epicentre, Médecins Sans Frontières (MSF), the Institute of Tropical Medicine Antwerp, WHO and Africa CDC.
CEPI funds the trial through its Bundibugyo virus vaccine development programme, supported 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. The statement noted that Gavi, the Vaccine Alliance, had committed up to $40 million to manufacturing readiness to help ensure vaccines could be available at scale if approved for deployment.
