Sabin Vaccine Institute, a US-based nonprofit organisation, has initiated a Phase 2 clinical trial of its vaccine against Sudan ebolavirus in healthy volunteers in Uganda.

The investigational Sudan ebolavirus vaccine has been built on the cAd3 platform like Sabin Vaccine Institute’s Marburg vaccine candidate. It has shown promising results in Phase 1 clinical and non-clinical studies. 

The Sudan ebolavirus vaccine candidate was found to be safe and capable of inducing rapid and strong immune responses lasting up to 12 months in previous studies.

The latest study marks Sabin Vaccine Institute’s second Phase 2 clinical trial collaboration with Makerere University Walter Reed Project (MUWRP) based in Kampala, Uganda.

Under the trial, healthy volunteers are receiving the single-dose vaccine at MUWRP.

Concurrently, a Phase 2 trial for a Marburg vaccine is ongoing at MUWRP, with enrolment recently completed and initial results anticipated later this year.

Enrolment will also commence in the coming weeks at the Kenya Medical Research Institute in Siaya, Kenya for the Sudan ebolavirus vaccine trial. A total of 125 volunteers will participate in the trial across both Uganda and Kenya.

Sabin Vaccine Institute CEO Amy Finan said: “We are delighted to advance a vaccine candidate that can thwart a deadly and devastating disease, especially one that caused a fairly recent outbreak and for which no approved treatments exist.

“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.”

The Phase 2 clinical trial aims to assess the safety and immunogenicity of the Sudan ebolavirus vaccine in a larger cohort compared to previous studies.

It is designed as a randomised, placebo-controlled, double-blind study. The participants, spanning younger, 18-50 years, and older, 51-70 years, age groups, will be monitored for one year, with interim results expected in 2025.

Alongside trials in Uganda and Kenya, Sabin Vaccine Institute intends to conduct a similar Phase 2 trial for the Sudan ebolavirus vaccine candidate in the US.

Funding for the trials is provided by the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services’ Administration for Strategic Preparedness and Response. This is through multi-year contracts with Sabin Vaccine Institute.

BARDA had paid approximately $216m so far to the vaccine organisation for advancing vaccine research and development against Sudan ebolavirus and Marburg virus diseases.

Collaboration between BARDA and Sabin Vaccine Institute began in September 2019 to develop these monovalent vaccine candidates.