The latest phase comes with the launch of a vaccination study known as BRAVO in Bunia, the capital of Ituri, conducted by Medecins Sans Frontieres (MSF) in collaboration with Congolese health authorities, the Africa Centers for Disease Control and Prevention (Africa CDC) and other scientific partners.
***
The study plans to vaccinate about 20,000 frontline workers in Ituri and North Kivu, two provinces most affected by the outbreak, and follow participants over time to assess the potential effect of Ervebo against the Bundibugyo virus.
Ervebo was developed and licensed against the Zaire virus rather than the Bundibugyo virus driving the current outbreak, and whether it can protect humans against the latter has not been established.
Amid the expanding outbreak, the International Coordinating Group on Vaccine Provision approved an initial allocation of 70,000 doses of Ervebo to the DRC in August. Of the total, 50,000 doses were allocated for health and frontline workers, while 20,000 were set aside for a Phase 3 clinical trial designed to assess the vaccine’s impact against the Bundibugyo virus.
According to the Africa CDC, 16,520 doses had been received in the DRC as of mid-September. The use of Ervebo had already begun on Aug. 27 under a protocol-governed program targeting people at high risk of exposure. As of Sept. 17, a total of 3,771 people had been vaccinated, including 3,063 in Tshopo Province and 708 in Bas-Uele Province, according to the latest epidemiological update issued Saturday by the DRC government.
BRAVO, which is expected to run for nine to 12 months, including three months of vaccination and at least six months of participant follow-up, marks a further step in efforts to generate evidence on the vaccine’s potential effectiveness against Bundibugyo. A separate Phase 3 trial, based on a randomized ring-vaccination strategy, is also planned to more rigorously assess Ervebo’s effectiveness.
According to the DRC government, the country has now reported 7,541 confirmed cases, including 3,639 deaths, with an overall case fatality rate of 48.3 percent. A total of 1,823 patients have recovered.
The outbreak, declared in May, has become the largest and deadliest Ebola outbreak ever recorded in the DRC and the second-largest Ebola outbreak globally, after the 2014-2016 West Africa epidemic.
