The collaboration between ReiThera and the Sabin Vaccine Institute has reached an important milestone in the fight against life-threatening infectious diseases, with the initiation of a Phase 2 clinical trial in Uganda for the development of a vaccine against Sudan ebolavirus. In support of this challenging effort led by Sabin, ReiThera has manufactured, released, and shipped the vaccine to Uganda.
Since 2019, ReiThera has been supporting the Sabin team by developing an innovative, intensified production process based on cell perfusion in stirred-tank bioreactors for the manufacturing of Sudan ebolavirus vaccine clinical lots. The introduction of this process step resulted in a more than fourfold increase in volumetric productivity compared to the standard process. This approach, combined with an updated downstream process, has led to the release of a high-quality product at the desired vaccine dose and since the beginning of the program, the equivalent of 200,000 doses of the Sudan ebolavirus vaccine have been manufactured and released by ReiThera.
This effort has generated an impressive vaccine stockpile, ready to be deployed in the event of an unanticipated outbreak in Africa. In December 2022, Reithera and Sabin, under the WHO umbrella, were the first to ship 1,100 doses of the Sudan ebolavirus vaccine to Uganda to help with a local outbreak.
Sudan ebolavirus is a filovirus, in the same family as Marburg virus disease and Zaire ebolavirus, which killed 11,325 people in the outbreak in West Africa from 2014 to 2016. Ebolavirus disease spreads between people via direct contact with the blood or other bodily fluids of infected individuals and is highly virulent, causing hemorrhagic fever and multiple organ failure.
Sabin’s single-dose investigational Sudan ebolavirus vaccine is based on the ChAd3 simian adenoviral platform. It was found to protect monkeys from death following viral inoculation and was safe and immunogenic in humans in two Phase 1 trials, generating antibody responses comparable to those observed in the protected monkeys. The Phase 2 clinical trial will evaluate the vaccine’s safety and immunogenicity in a larger group of individuals in sub-Saharan Africa where the disease 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. “Our work with Sabin exemplifies how our innovative production processes can make a significant impact in readiness and response to unexpected health emergencies.”
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