The Sabin Vaccine Institute has begun a Phase II trial in the US to evaluate its Marburg vaccine, with the first doses being given to subjects in Melbourne, Florida.
The trial aims to enrol 200 subjects aged 18 to 70 years at sites in Alabama, Illinois and Texas, as well as Melbourne.
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The double-blind, placebo-controlled study will continue to assess the vaccine’s immunogenicity and safety by monitoring participants over a year.
It expands on Phase II research being carried out in Uganda and Kenya, with preliminary outcomes from those trials expected in the coming months.
Sabin Vaccine Institute CEO Amy Finan said: “Recent outbreaks highlight the urgent need to strengthen our defences against this deadly and unforgiving disease.
“Sabin’s Phase II clinical trials will generate essential data to move this vaccine closer to licensure — and offer a potentially life-saving tool where none exists.”
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By GlobalDataThere are currently no approved vaccines for the Marburg virus disease, a virulent condition leading to haemorrhagic fever.
The disease is caused by the Marburg filovirus, which belongs to the Ebola virus family.
Sabin’s investigational vaccine is based on GSK’s Chimpanzee Adenovirus Type 3 (cAd3) platform and has shown promise in Phase I clinical and non-clinical trials, demonstrating safety and the ability to cause quick immune responses.
Sabin is developing the vaccine amid more frequent outbreaks of the Marburg virus disease, highlighting the need for vaccines to protect high-risk populations.
During Rwanda’s Marburg outbreak last year, the institute contributed to an open-label Phase II trial by supplying the vaccine, which was administered to more than 1,700 subjects within nine days of the outbreak being declared.
Rwanda Biomedical Centre (RBC) offered support for this open-label trial, the data from which will play a key role in supporting the vaccine’s licensure process.
