The International AIDS Vaccine Initiative (IAVI) has dosed the first patients with a Sudan ebolavirus (SUDV) vaccine candidate in first-in-human Phase I clinical trial (NCT05724472) in response to the rapidly spreading outbreak of SUDV disease in Uganda.
Non-profit scientific research organisation IAVI was donated the investigational vaccine candidate called rVSV-SUDV-GP by Merck (MSD) to assist the company’s SUDV vaccine development programme.
The vaccine candidate was produced from an existing investigational bulk drug substance previously manufactured by MSD. It uses the same recombinant vesicular stomatitis virus (rVSV) viral vector platform as ERVEBO, a highly efficacious single-dose Zaire ebolavirus vaccine from MSD, which is licensed in the US, UK, EU, Canada, Switzerland, and ten African countries.
rVSV-SUDV-GP is not the only vaccine in development by IAVI
rVSV-SUDV-GP will be pitted against IAVI’s other SUDV vaccine candidate, which utilises the same viral vector but is manufactured using a new production platform.
IAVI is being supported by the Biomedical Advanced Research and Development Authority (BARDA).
IAVI C108 will begin at two US-based clinical trial sites in Austin and San Antonio, and the vaccine will be administered intramuscularly at three dosage levels. It is a placebo-controlled, single-blinded study, which plans to enrol 36 healthy participants who will be followed up for six months after vaccination to monitor safety and immune responses.
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IAVI vice-president and emerging infectious diseases and epidemiology head Dr Swati Gupta said: “IAVI C108 represents an important first step toward generating the data needed for eventual licensure of an rVSV-SUDV vaccine. The development and licensure of ERVEBO have resulted in an important tool in Ebola Zaire outbreak response.
“If proven effective, we are hopeful that a vaccine candidate built on the same viral platform will be similarly important in future SUDV outbreaks. In parallel, we must continue accelerating efforts toward the adequate availability of candidate vaccine doses for evaluation during and ahead of outbreaks with key partners, collaborators, and funders.
“We are grateful to Merck for donating the doses that will be used in IAVI C108 and to BARDA for its support of this trial.”
What symptoms do SUDV patients suffer from?
SUDV patients suffer from recurring viral haemorrhagic fever outbreaks, which cause lasting impacts on health security and geopolitical stability across sub-Saharan Africa.
Symptoms can be abrupt and include fever, fatigue, headache, muscle pain, sore throat, vomiting, rash, diarrhoea, and impaired kidney and liver function symptoms.
Fatality ratios have varied between 41% to 100% in past outbreaks, and there are currently no vaccines or therapeutics licensed for the prevention and treatment of SUDV.