Scientists are preparing to test vaccine candidates against the Bundibugyo virus in the Democratic Republic of the Congo (DRC).
The Phase 2/3 clinical trial, expected to begin in the coming weeks subject to ethical and regulatory approval, will assess the safety and effectiveness of existing and experimental vaccines against the virus.
The Coalition for Epidemic Preparedness Innovations (CEPI) said on Tuesday that preparations were underway for the trial, named Tumaini, which means “hope” in Swahili.
“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),” it said.
The trial will initially prioritise Ervebo, a vaccine licensed against the Zaire strain of Ebola virus. Its ability to protect against Bundibugyo virus has yet to be established.
Although both viruses belong to the same genus, Bundibugyo virus is a distinct species. Approval of a vaccine against one species does not establish that it will protect against another.
The World Health Organisation’s Technical Advisory Group on Candidate Vaccine Prioritisation has recommended that Ervebo be evaluated in a Phase 3 trial. Vaccine candidates specifically developed against Bundibugyo virus are also expected to be included as they become available.
Two vaccines designed specifically for Bundibugyo virus are undergoing Phase 1 trials. They are being developed by Moderna and the University of Oxford in collaboration with the Serum Institute of India.
The Tumaini trial will use an adaptive platform design, allowing researchers to assess multiple vaccine candidates within a single trial framework.
Researchers also plan to use a ring vaccination strategy, targeting contacts of infected people and others at high risk of infection.
The Institut National de Recherche Biomédicale and the University of Antwerp’s Global Health Institute are leading and co-sponsoring the trial under the oversight of the DRC Ministry of Health.
The Africa Centres for Disease Control and Prevention is supporting African-led clinical research and regional coordination, while the World Health Organisation is providing scientific and technical guidance.
Other participating organisations include Epicentre, Médecins Sans Frontières and the Institute of Tropical Medicine Antwerp. CEPI is providing funding and technical support.
The trial is funded through CEPI’s Bundibugyo virus vaccine development programme, with contributions from the European Commission, the United States Department of State, the Fund for Science and Technology, and CEPI’s core funding.
