Sabin Vaccine Institute Initiates Phase 2 Clinical Trial for Sudan Ebolavirus Vaccine
Tuesday, July 16, 2024
Sabin Vaccine Institute has launched a Phase 2 clinical trial for its vaccine against Sudan ebolavirus at Makerere University Walter Reed Project (MUWRP) in Uganda. This strain of ebolavirus lacks approved vaccines and was involved in a recent outbreak that resulted in significant fatalities. According to the World Health Organization, Sudan ebolavirus typically has a fatality rate of about 50% among those infected.
Sudan ebolavirus belongs to the filovirus family, which includes Marburg virus disease and Zaire ebolavirus. The latter caused over 11,000 deaths during an outbreak in West Africa from 2014-16. The disease spreads through direct contact with bodily fluids of infected individuals and causes severe hemorrhagic fever.
Sabin’s vaccine candidate for Sudan ebolavirus uses the cAd3 platform, similar to their Marburg vaccine candidate. Phase 1 clinical and non-clinical studies have shown promising results, indicating safety and robust immune responses lasting up to 12 months.
This marks Sabin’s second Phase 2 collaboration with MUWRP in Uganda’s capital, Kampala, following ongoing trials for a Marburg vaccine. Dr. Betty Mwesigwa, deputy executive director of MUWRP, is leading the current Sudan ebolavirus trial. Additional participants will be enrolled at Kenya Medical Research Institute in Siaya, Kenya, under the supervision of Dr. Videlis Nduba. The trial aims to involve 125 volunteers across both countries.
Sabin, emphasized the potential of their vaccine to combat this deadly disease, particularly given its recent outbreak history and lack of approved treatments. She highlighted the vaccine’s strong safety and immune response data, expressing optimism that this trial will provide further evidence for its eventual approval.
The most recent Sudan ebolavirus outbreak occurred in Uganda's Mubende district in fall 2022, resulting in 55 deaths. Sabin’s vaccine was included by the WHO as a candidate during this outbreak, although it ended before deployment.
The Phase 2 trial focuses on evaluating safety and immune responses in a larger cohort than previous phases. It employs a randomized, double-blind, placebo-controlled approach to minimize bias. Participants, spanning younger (18-50 years) and older (51-70 years) age groups, will be monitored for a year, with interim results anticipated next year.
Funding for the Sudan ebolavirus vaccine trials is provided by BARDA, part of the U.S. Department of Health and Human Services, under multi-year contracts totaling $216 million. This partnership commenced in September 2019 to develop monovalent vaccine candidates against Sudan ebolavirus and Marburg virus diseases.
Sabin’s research and development efforts utilize the cAd3 platform, licensed exclusively from GSK since August 2019, following collaborative development with the U.S. NIH and Okairos. This technology underpins their prophylactic vaccines targeting Zaire ebolavirus, Sudan ebolavirus, and Marburg virus.
In summary, Sabin’s Phase 2 clinical trial for the Sudan ebolavirus vaccine represents a critical step towards potentially addressing this lethal disease, leveraging robust partnerships and significant research funding.
Source: globenewswire.com
