Sabin Vaccine Institute announced in July 2024 that it has launched a Phase II clinical trial for its vaccine against Sudan ebolavirus. The trial of healthy volunteers takes place at Makerere University Walter Reed Project (MUWRP) in Uganda. The vaccine is based on the cAd3 platform and appeared “promising” in Phase I clinical and non-clinical studies. Ebolavirus disease kills “on average half the people infected”, and there are no approved vaccines for the Sudan strain.
Sudan ebolavirus
Sudan ebolavirus is a “lesser known” filovirus than Ebola Zaire. It can cause severe haemorrhagic fever in humans and nonhuman primates. It is transmitted to humans by infected animals, particularly fruit bats, and can then spread to others through close personal contact or contact with bodily fluids. The most recent outbreak of Sudan ebolavirus occurred in 2022 in Uganda, identified after six suspicious deaths in the Mubende district. The outbreak caused 55 deaths but concluded before a vaccine was deployed for use in an outbreak trial.
The vaccine in trial
In 2019 Sabin announced exclusive agreements with GSK to advance the development of prophylactic candidate vaccines against Zaire ebolavirus, Sudan ebolavirus, and Marburg virus. The Sudan ebolavirus candidate, based on the CAd3 platform, is a single-dose investigational vaccine that has proven safe and capable of eliciting “rapid and robust” immune responses in study
The latest trial will enrol 125 volunteers at MUWRP and the Kenya Medical Research Institute in Siaya, Kenya. It will evaluate the safety and immunogenicity through a randomised, placebo-controlled, double-blind approach. Participants will be monitored for a year and will include younger (18-50) and older (51-70) age groups.
Dr Betty Mwesigwa, deputy executive director of MUWRP and principal investigator at the site, is “pleased” to partner with Sabin again.
“Uganda has the most experience with Sudan ebolavirus outbreaks so we understand the importance of testing and researching an effective Sudan ebolavirus vaccine that could be used in the event of an outbreak.”
Sabin’s Chief Executive Officer, Amy Finan, is “delighted to advance a vaccine candidate that can thwart a deadly and devastating disease”. This is particularly important in the context of a “fairly recent outbreak” and lack of approved treatments.
“Sabin’s vaccine candidate is backed by strong safety and immunogenicity data, and we hope this trial will yield further evidence to move the vaccine closer to licensure.”
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