Uganda’s Ministry of Health, in collaboration with the World Health Organization (WHO) and key partners, has today launched the first-ever clinical efficacy trial for a vaccine targeting the Sudan species of the Ebola virus. This groundbreaking initiative marks the fastest deployment of a randomized vaccine trial during an outbreak.
The vaccine, developed by IAVI, previously underwent Phase 1 and Phase 2 trials to confirm its safety and immunogenicity. This is the first time the vaccine is being tested for efficacy during an active outbreak.
The trial, co-sponsored by WHO, was organized within just four days following the confirmation of the outbreak on January 30. Principal investigators from Makerere University and the Uganda Virus Research Institute (UVRI) led the setup, supported by WHO and other partners.
“This is a critical achievement towards better pandemic preparedness and saving lives when outbreaks occur,” said Dr. Tedros Adhanom Ghebreyesus, WHO Director-General. He commended Uganda’s health workers, communities, and research teams for their dedication.
The trial involves a recombinant vesicular stomatitis virus (rVSV) candidate vaccine. Three vaccination rings have already been defined, with the first targeting approximately 40 contacts linked to a health worker who died from the disease.
The candidate vaccine was donated by IAVI, with financial backing from WHO, CEPI, Canada’s International Development Research Centre (IDRC), the European Commission’s Health Emergency Preparedness and Response Authority (HERA), and support from the Africa CDC.
Despite progress, there is currently no licensed vaccine available to combat Ebola disease from the Sudan virus species. Existing licensed vaccines and treatments are effective only against the Ebola virus, previously known as Zaïre ebolavirus.
The trial’s success could contribute significantly to controlling the outbreak and generating critical data for potential vaccine licensure.