- ReiThera has commenced a Phase 2 clinical trial in Uganda for a vaccine against Sudan ebolavirus, having manufactured and shipped the vaccine in support of the initiative led by the Sabin Vaccine Institute.
- The collaboration has resulted in the production of 200,000 vaccine doses, utilising an innovative production process that increased volumetric productivity by more than four times.
ReiThera, a CDMO company dedicated to technology and process development and GMP manufacturing has initiated a Phase 2 clinical trial in Uganda for a vaccine targeting the Sudan ebolavirus, marking a significant step in addressing life-threatening infectious diseases. The trial is part of a collaboration with the Sabin Vaccine Institute, which has been ongoing since 2019. ReiThera has played a crucial role by manufacturing, releasing, and shipping the vaccine to Uganda to support the trial.
This initiative follows the development of a new production process based on cell perfusion in stirred-tank bioreactors, which has significantly enhanced vaccine production capabilities. This method has increased volumetric productivity by over fourfold compared to standard processes. As a result, ReiThera has manufactured and released the equivalent of 200,000 doses of the Sudan ebolavirus vaccine, creating a stockpile ready for deployment in the event of an outbreak in Africa.
In December 2022, ReiThera and Sabin shipped 1,100 doses of the vaccine to Uganda to assist with a local outbreak, demonstrating their commitment to rapid response. The Sudan ebolavirus, which is closely related to other deadly viruses like Marburg and Zaire ebolavirus, poses a high risk of transmission through direct contact with infected bodily fluids.
The investigational vaccine, based on the ChAd3 simian adenoviral platform, has shown promise in protecting animals and has been deemed safe and immunogenic in two Phase 1 trials. The ongoing Phase 2 trial aims to further evaluate the vaccine’s safety and immunogenicity in a larger population in sub-Saharan Africa, where Sudan ebolavirus is endemic.
“Our ability to rapidly produce and deliver high-quality vaccine doses underscores ReiThera’s dedication to supporting Sabin and the global health community in preparing for and responding to unexpected outbreaks,” says Stefano Colloca, Chief Executive Officer of ReiThera. This collaboration exemplifies the potential of innovative production processes in enhancing readiness against health emergencies.
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