DR Congo Ebola cases pass 9,000 as Bundibugyo vaccine trial nears start

The Democratic Republic of Congo (DRC) had recorded 9,066 confirmed Ebola cases and 4,381 deaths as of 11 October, according to a situation report from the country's national Ebola task force, Xinhua reported on 13 October. The outbreak is caused by the Bundibugyo strain, for which no vaccine or treatment has been approved.

The Coalition for Epidemic Preparedness Innovations (CEPI) said on 13 October that final preparations are under way for Tumaini, a Phase 2/3 trial of vaccine candidates against the Bundibugyo virus. The trial is expected to start “in the coming weeks”, subject to ethical and regulatory approval.

The outbreak, declared on 15 May, is the largest and deadliest Ebola outbreak recorded in the DRC. It is the second-largest worldwide after the 2014–2016 West Africa epidemic, which the World Health Organization says caused 28,600 confirmed cases and more than 11,000 deaths in Guinea, Liberia and Sierra Leone, according to an Associated Press report published by Al Jazeera on 13 October.

Cases have been recorded in 65 health zones in seven provinces. Ituri Province accounts for 73.8 per cent of confirmed cases, and North Kivu Province has the highest case fatality rate, at 57.1 per cent. The national rate is 48.3 per cent, and 2,389 patients have recovered.

Health Minister Roger Kamba said earlier this month that the outbreak was becoming more localised, with some zones reporting no new cases for weeks. WHO Director-General Tedros Adhanom Ghebreyesus said on 7 October that the epidemic was slowing in some areas but continued to grow in others, and raised concern about the high proportion of deaths occurring in communities and gaps in contact tracing.

Ervebo, a vaccine approved for the Zaire strain of Ebola, is being given to frontline health workers under research protocols and compassionate-use arrangements. The task force report showed that 399 frontline workers had been vaccinated in Haut-Uele Province as of 11 October. The vaccine's effectiveness against the Bundibugyo strain has not been proven.

Tumaini is an adaptive platform trial that will evaluate the safety, immunogenicity and efficacy of vaccine candidates. The candidates will be assessed through ring vaccination, focused on contacts at high risk of infection. “Ervebo is likely to be the first vaccine to enter the trial,” CEPI said.

Two Bundibugyo-specific candidates, one from Moderna and one from the University of Oxford with the Serum Institute of India, are in Phase 1 trials and will join the study as they become available.

The Institut National de Recherche Biomédicale (INRB) and the University of Antwerp lead and co-sponsor the trial. The DRC Ministry of Health provides national leadership, and its Incident Response Manager chairs the Trial Steering Committee. Epicentre, Médecins Sans Frontières, the Institute of Tropical Medicine Antwerp, WHO and Africa CDC are implementation partners, and CEPI provides funding. The trial is registered on ClinicalTrials.gov as NCT07842107.

Dr Chikwe Ihekweazu, executive director of the WHO Health Emergencies Programme, said on 13 October that a clinical trial to evaluate vaccine efficacy against the Bundibugyo strain is being prepared for the DRC in the coming weeks, according to the Associated Press report carried by Al Jazeera.

The same report said many communities distrust health workers, and that fighting between the M23 rebel group and government forces makes it hard to move supplies to remote areas.

Kenya's Ministry of Health confirmed a second case on 14 October: a 39-year-old man, a close family member of the country's first patient, who developed fever, fatigue and joint pains on 13 October while in quarantine, Eastleigh Voice reported. Kenya has recorded two confirmed cases and one death; the ministry said the two cases are linked and there is no evidence of wider community transmission. The first patient, a Kenyan who had lived in the DRC, travelled through Uganda and died in Nairobi. Uganda reported 20 cases and two deaths earlier this year and was declared Ebola-free in August.