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In a historic move, Uganda, in collaboration with the World Health Organization (WHO) and other global partners, has launched the first-ever clinical trial for a vaccine targeting the Sudan species of the Ebola virus.
The trial, initiated just four days after the confirmation of an outbreak on January 30, marks an unprecedented speed for a randomized vaccine trial in an emergency setting, WHO said in a press statement.
While licensed vaccines exist for the Ebola virus species formerly known as Zaire ebolavirus, no licensed vaccine is currently available for the Sudan species. If this candidate vaccine proves effective, it could play a pivotal role in controlling future outbreaks and pave the way for regulatory approval.
The vaccine trial is being led by principal investigators from Makerere University and the Uganda Virus Research Institute (UVRI), with support from WHO and other partners. This is the first time a vaccine is being assessed for clinical efficacy against Ebola disease caused by the Sudan virus.
Despite the rapid initiation, the trial adheres to stringent national and international regulatory and ethical standards, WHO stated.
The candidate vaccine, a recombinant vesicular stomatitis virus (rVSV) vaccine, was donated by the non-profit organization IAVI. Financial and logistical support has come from WHO, the Coalition for Epidemic Preparedness Innovations (CEPI), Canada’s International Development Research Centre (IDRC), and the European Commission's Health Emergency Preparedness and Response Authority (HERA), with additional backing from the Africa Centres for Disease Control and Prevention (Africa CDC).
WHO Director-General Dr Tedros Adhanom Ghebreyesus hailed the initiative as a critical step towards improving global pandemic preparedness. “We thank our partners for their dedication and cooperation, from IAVI for donating the vaccine, to CEPI, EU HERA and Canada’s IDRC for funding, and Africa CDC for further support. This massive achievement would simply not be possible without them,” he said.
The launch of the trial follows efforts from Uganda’s health authorities in 2022, during a previous outbreak of the Sudan virus, to develop a randomised protocol for evaluating vaccine candidates.
The randomised trial follows a ring vaccination strategy, a proven method for containing infectious disease outbreaks. In the first phase of the trial, three vaccination rings were identified, with approximately 40 individuals — including contacts and contacts of contacts of the first confirmed case, a deceased health worker — set to receive the vaccine.
With the rapid deployment of the trial, researchers hope to gather meaningful data within months, accelerating progress towards a licensed vaccine for Ebola disease caused by the Sudan virus. The global health community will closely monitor the results, which could inform future outbreak responses and vaccine development strategies.