Phase 1 clinical development
A platform approach to vaccine development
All of IAVI’s emerging infectious disease vaccines use the same technology behind Merck’s Ebolavirus vaccine, ERVEBO®, which is licensed in more than a dozen countries.
IAVI and our partners are developing a single-dose vaccine candidate for protection against SUDV and contributed to outbreak responses in sub-Saharan Africa. Several SUDV vaccines are in development, though none are yet approved for use.
SUDV (family Filoviridae) is an orthoebolavirus that repeatedly spills over from wildlife into humans to cause outbreaks of Sudan virus disease (SVD) — sometimes called Ebola disease — a severe viral hemorrhagic fever with a high case fatality rate. SUDV is included in the World Health Organization (WHO) pathogen prioritization framework to accelerate medical countermeasures to respond to epidemics and pandemics.
IAVI’s SUDV vaccine candidate* is currently in Phase 1 clinical development. Results from a Phase 1, placebo-controlled clinical trial conducted in the U.S. (NCT05724472) demonstrated that one dose has an acceptable safety profile and elicts an immune response that can be detected for at least six months after vaccination. Preclinical challenge studies show that 100% of vaccinated animals were protected from infection with one dose.
IAVI’s SUDV vaccine R&D program is funded by the U.S. Biomedical Advanced Research Authority, the Dutch Government, and the Japanese Ministry of Finance.
*In 2022, Merck, known as MSD outside the United States and Canada, produced and donated to IAVI vials of rVSV∆G-SEBOV-GP candidate vaccine from existing investigational drug substance to supplement IAVI’s ongoing SUDV vaccine development program. IAVI now acts as developer and regulatory sponsor and is responsible for all aspects of future development of rVSV∆G-SEBOV-GP.
More about SUDV
Rapid response
In 2025, WHO prioritized evaluation of IAVI’s SUDV candidate vaccine*, which was already prepositioned in Uganda, as part of a global collaborative effort supporting the country’s SVD outbreak response. The resulting ring vaccination trial (TOKEMEZA SVD) was initiated by Makerere University Lung Institute in Kampala just four days after the outbreak was declared.
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SUDV vaccines or therapeutics
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Reported Ebola outbreaks caused by SUDV in sub-Saharan Africa
