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DRC vaccinates first participant as the Phase 2/3 Tumaini trial begins in Bunia to test vaccines against Bundibugyo virus.
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9,552 cases and 4,602 deaths were recorded as of October 21 in the country’s largest recorded Bundibugyo outbreak.
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Three vaccine candidates will be assessed, including Ervebo and experimental candidates developed by Moderna and Oxford with the Serum Institute of India.
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No vaccine is specifically approved for Bundibugyo virus, making the trial crucial to the fight against the current outbreak and future epidemics.
October 23, (THEWILL) – The Democratic Republic of the Congo (DRC) has commenced a pivotal Phase 2/3 clinical trial to determine whether vaccine candidates can protect against the deadly Bundibugyo virus, following the vaccination of the first participant in Bunia.
The first participant was vaccinated on Friday, marking the commencement of the Tumaini trial, which is being conducted as part of the country’s response to the ongoing outbreak.
A statement signed on Friday by Jodie Rogers, Senior Communications and Advocacy Manager at the Coalition for Epidemic Preparedness Innovations (CEPI), said that the trial is designed to generate evidence on the safety, immune response and effectiveness of potential vaccines against Bundibugyo virus, for which there is currently no vaccine specifically approved for human use.
The study comes as the DRC battles what CEPI described as the largest recorded Bundibugyo virus disease outbreak and the second-largest Ebola outbreak to date.
As of October 21, the country had recorded 9,552 cases and 4,602 deaths, according to figures cited by CEPI.
The outbreak was declared on May 15 and subsequently designated a Public Health Emergency of International Concern by the World Health Organisation (WHO).
The Africa Centres for Disease Control and Prevention (Africa CDC) also designated the outbreak a Public Health Emergency of Continental Security.
Named after the Swahili word for “hope”, the Tumaini trial will evaluate multiple vaccine candidates to establish whether they can safely and effectively protect people at high risk of infection.
Three Vaccine Candidates
The first candidate to enter the trial is Ervebo, a vaccine licensed for the prevention of Ebola virus disease caused by the Zaire ebolavirus species. However, its effectiveness against Bundibugyo virus in humans remains unknown.
CEPI said the trial would therefore provide critical evidence on whether Ervebo can protect against the virus responsible for the current outbreak.
Two Bundibugyo-specific vaccine candidates are also expected to enter the study as they become available. The candidates are being developed by Moderna and by the University of Oxford in collaboration with the Serum Institute of India, with funding from CEPI.
The trial will use an adaptive platform design, allowing several vaccine candidates to be assessed within a single clinical trial framework.
CEPI said the approach could save valuable time during an outbreak by enabling researchers to evaluate multiple candidates under one coordinated protocol rather than conducting separate trials.
The candidates will be assessed through a ring vaccination strategy, focusing on eligible contacts of confirmed cases who face a higher risk of infection.
Candidate selection is being guided by an independent prioritisation process led by the WHO Technical Advisory Group on Candidate Vaccine Prioritisation.
Any corresponding protocol amendments will be subject to approval by the DRC’s national regulatory authority.
DRC Leads Trial
The Institut National de Recherche Biomédicale (INRB) and the University of Antwerp’s Global Health Institute are co-leading and co-sponsoring the trial, while the DRC Ministry of Health is providing national leadership and oversight.
A Trial Steering Committee, chaired by the ministry’s Incident Response Manager, will provide strategic oversight and ensure the study remains aligned with the broader outbreak response and other investigations into medical countermeasures.
Prof. Steve Ahuka-Mundeke, Incident Manager of the Ebola Response in the DRC, said integrating the trial into the outbreak response was essential to addressing the urgent needs of affected communities.
He said the priority remained stopping transmission and saving lives while ensuring research activities were coordinated with frontline response operations.
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Prof. Hugo Kavunga, Co-Sponsor and Principal Investigator at INRB, described the vaccination of the first participant as a significant milestone achieved through the efforts of Congolese researchers, health workers and their partners.
He said the study placed national scientific leadership at the centre of the outbreak response, with the priority of determining which vaccines could safely and effectively protect people at risk.
Prof. Jean-Pierre Van Geertruyden, Co-Sponsor and Co-Principal Investigator at the University of Antwerp, said the trial brought together Congolese and international expertise to generate reliable evidence on vaccines against Bundibugyo virus.
No Approved Vaccine
CEPI Chief Executive Officer, Dr Richard Hatchett, said the absence of a licensed vaccine specifically targeting Bundibugyo virus had left affected communities and health workers without an approved vaccine against the disease.
He said the commencement of the trial would help generate the evidence required to determine whether candidate vaccines could safely and effectively protect those most at risk.
WHO Health Emergencies Programme Executive Director, Dr Chikwe Ihekweazu, described the trial as a critical step towards determining whether the candidate vaccines could protect people against Bundibugyo virus.
He said the adaptive platform and ring vaccination approach would provide a structured way to evaluate potential vaccines during an active outbreak.
According to Ihekweazu, if successful, the trial could generate the first clear evidence of vaccine efficacy against Bundibugyo virus, potentially improving the response to the current outbreak and future epidemics.
Prof. Placide Mbala, Director of Research, Clinical Trials and Innovation at Africa CDC, said the trial demonstrated the importance of African-led research in addressing public health challenges on the continent.
He said the initiative would generate high-quality scientific evidence to support the current response while strengthening preparedness for future epidemics.
Community Participation
CEPI said the trial would work closely with affected communities, health authorities and response partners to ensure that research activities are properly coordinated with outbreak-control measures.
It said community participation would be essential to building trust and ensuring meaningful involvement in the evaluation of vaccines intended for populations at risk.
The ring vaccination strategy will focus on eligible contacts of confirmed cases, who are considered to face a higher risk of infection.
International Support
CEPI is providing funding, scientific expertise and operational support, while WHO is contributing strategic, technical and scientific advice.
Other partners supporting the trial include Epicentre, Médecins Sans Frontières (MSF), the Institute of Tropical Medicine Antwerp (ITM) and Africa CDC.
WHO has also adapted protocols developed through its Research and Development Blueprint to facilitate the rapid establishment of the trial within the emergency response.
The trial is funded through CEPI’s Bundibugyo virus vaccine development programme, backed by the European Commission, the United States Department of State, the Fund for Science and Technology, the Republic of Korea and CEPI’s core funding.
Gavi, the Vaccine Alliance, has committed up to $40 million to support manufacturing readiness, with the aim of ensuring that successful vaccines can be produced at scale once approved for deployment.
Background
Bundibugyo virus is a member of the Ebolavirus genus and can cause severe and potentially fatal disease.
The virus was first identified during an outbreak in Uganda’s Bundibugyo District in 2007. It is distinct from the Zaire ebolavirus, against which the Ervebo vaccine is licensed.
While vaccines have been developed against Zaire ebolavirus, no vaccine has yet been specifically approved for preventing Bundibugyo virus disease.
The absence of a dedicated vaccine has left outbreak control dependent on measures including early detection, isolation and treatment of cases, contact tracing, infection prevention and control, vaccination where appropriate with investigational or cross-protective candidates, and community engagement.
The current outbreak has intensified the need to establish whether existing vaccines can offer protection against Bundibugyo virus and whether newer, virus-specific candidates can provide safe and effective protection.
The Tumaini trial is expected to generate evidence that could guide vaccine-use decisions during the current outbreak while strengthening preparedness for future Bundibugyo virus epidemics.
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