Negotiations between health officials in the Democratic Republic of the Congo and the World Health Organization are progressing to initiate a multi-armed Phase 3 clinical trial examining vaccines designed to combat the spread of Bundibugyo virus in the country’s northeast region. According to the WHO director-general, the current outbreak represents the second-largest Ebola epidemic documented and is advancing at a faster rate than any previous occurrence of the disease, putting it on track to surpass the West African Ebola outbreak of 2014-2016 as the most extensive on record.
Merck’s Ervebo vaccine, which targets a different Ebola species known as Ebola Zaire, will be the first vaccine candidate evaluated in field trials. Though a WHO expert advisory panel initially demonstrated hesitation regarding its use, accumulating research findings from animal and human studies have prompted reconsideration, suggesting the vaccine may provide some degree of cross-protection against Bundibugyo. As of Monday, the outbreak had resulted in more than 4,500 confirmed cases centered in the DRC’s Ituri province, with more than 2,060 deaths recorded.
The trial design will randomize known contacts of infected individuals to receive either Ervebo or a placebo, differing from the ring vaccination methodology used in prior efficacy studies. Additional vaccines specifically targeting the Bundibugyo species are expected to be incorporated into the trial as they become available. The WHO indicated it is preparing to submit the trial protocol to regulatory and ethics authorities in the DRC for approval. Officials from both Oxford Vaccine Group and Moderna are developing candidate vaccines against Bundibugyo, with Phase 1 trial results anticipated in September. A third vaccine candidate is being developed by the nonprofit organization IAVI, though sufficient doses for Phase 3 testing will not be available for several months.
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