By Muhammad Amaan
The Coalition for Epidemic Preparedness Innovations (CEPI) says final preparations are underway for a Phase 2/3 clinical trial to evaluate vaccine candidates against Bundibugyo virus in the Democratic Republic of the Congo (DRC).
CEPI in a statement obtained by the Health Reporters, said the trial, named Tumaini, meaning “hope” in Swahili, will assess the safety, immunogenicity and efficacy of vaccine candidates, including Ervebo, subject to ethical and regulatory approval.
The statement said the trial was expected to begin in the coming weeks and would support the government-led response to the ongoing outbreak.
“There is currently no approved vaccine against Bundibugyo virus,” CEPI said, highlighting the gap the trial seeks to address.
It added that the World Health Organization’s Technical Advisory Group on Candidate Vaccine Prioritisation had recommended Ervebo for evaluation in a Phase Three trial, with Bundibugyo-specific candidates to be included when available.
CEPI said that Ervebo was licensed to prevent Ebola virus disease caused by the Zaire strain, while its effectiveness against Bundibugyo virus remained to be evaluated.
The statement said the trial would adopt an adaptive platform design, allowing several candidates to be assessed in parallel within one framework, thereby saving time during an outbreak.
CEPI said the candidates would be evaluated through ring vaccination, which targeted contacts at high risk of infection.
It also said the Institut National de Recherche Biomédicale and the University of Antwerp’s Global Health Institute would lead and co-sponsor the study.
“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.
“Also, supporting timely and equitable access to successful vaccine candidates,” CEPI said.
Other partners include Epicentre, Médecins Sans Frontières and the Institute of Tropical Medicine Antwerp, while CEPI provides funding, scientific expertise and operational support.
The statement said two Bundibugyo-specific vaccine candidates, developed by Moderna and the University of Oxford in collaboration with the Serum Institute of India, were currently undergoing Phase One trials.
“Ervebo is likely to be the first vaccine to enter the trial,” it said.
CEPI has been supporting the development of Bundibugyo-specific vaccines, including candidates at different stages of research, to expand options for responding to outbreaks.
The organisation’s wider programme also supports research into vaccine candidates that could be evaluated against the virus, alongside efforts to strengthen preparedness for emerging infectious disease threats.
The Tumaini 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, and CEPI’s core funding.
