In the eastern part of the Democratic Republic of Congo (DRC), a large-scale clinical trial of vaccines designed to combat the Bundibugyo Ebola virus began on Friday. The first participants were vaccinated in the country that is battling the largest registered outbreak of this virus.
The Phase 2/3 trial, named Tumaini, was launched in Bunia, the capital of the most affected province of Ituri. The research is funded and supported by the Coalition for Epidemic Preparedness Innovations.
This situation unfolds against the backdrop of an escalating Ebola crisis, which has claimed over 4,600 lives in the DRC since May. Despite the scale of the outbreak, no vaccine specifically developed against the Bundibugyo virus has been approved yet.
Tumaini, which translates to 'hope' in Swahili, aims to assess the safety, immune response, and efficacy of several vaccine candidates. Special attention is paid to people who have been in contact with confirmed Ebola patients and are at high risk of infection.
The study uses an adaptive platform design, allowing multiple vaccine candidates to be evaluated within a single study through a ring vaccination approach targeting contacts of confirmed cases.
The first vaccine included in the trial is Ervebo. This vaccine already has a license to prevent diseases caused by the Zaire ebolavirus, but its effectiveness against the Bundibugyo virus has not yet been proven.
Two more vaccines specifically developed against the Bundibugyo virus are expected to join the trial soon: one developed by Moderna, and the other by Oxford University in collaboration with the Serum Institute of India.
Chike Ikechewazu, Executive Director of the World Health Organization's Emergency Programme, noted that the launch of the Tumaini trial is a critical step in determining the ability of candidate vaccines to effectively protect people from the Bundibugyo virus.
WHO Regional Director for Africa, Mohamed Janabi, also welcomed the start of the trial on Friday. He emphasized that the study will provide vital data on candidate vaccines while strengthening the response to the current outbreak and preparedness for future epidemics.
According to the latest data published Wednesday by local DRC health authorities, 9,704 confirmed cases of Ebola, including 4,687 deaths, were recorded as of October 20, corresponding to a fatality rate of 48.3%.
The epidemic was declared in the DRC on May 15, and two days later, the WHO classified it as a public health emergency of international concern. Subsequently, the African Centre for Disease Control and Prevention declared it a continental security emergency.
The current Ebola outbreak is the largest and deadliest in the history of the DRC and the second-largest Ebola outbreak in the world after the West Africa epidemic during 2014–2016.