Formulation development of a stable, orally delivered live human neonatal rotavirus(rv3-bb) vaccine candidate
June 17-22, 2018
Rotavirus is the most common cause of gastroenteritis among children under 5 years of age leading to ~200,000 deaths in 2013.1 Rotavirus-attributed mortality can be significantly reduced by promoting global implementation of rotavirus vaccination by vaccine dosage cost reduction and optimizing vaccine efficacy in low-resource countries. Furthermore, a rotavirus vaccine administered at birth could prevent neonatal mortality and reduce the risk of intussusception 2. An oral human neonatal rotavirus vaccine candidate (RV3-BB) has been developed from the human neonatal rotavirus strain RV3 (G3P) 2 , and a recently published Phase IIb clinical trial showed RV3-BB was efficacious in preventing severe rotavirus gastroenteritis via a neonatal or infant schedule in Indonesia2. The overall goals of this project are to develop and implement commercially viable bulk and drug product manufacturing processes of a stable liquid formulation for oral delivery (without pre-neutralization) that is affordable in the developing world (Fig. 1). The consortium working on this program is sponsored by the Bill and Melinda Gates Foundation between Batavia Biosciences, Murdoch Children’s Research Institute, BioFarma, and The University of Kansas.
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Prashant Kumar, Swathi Pullagurla, Ravi S. Shukla, Ashaben Patel, Christopher Bird, Ozan Kumru, Sangeeta B. Joshi, and David B. Volkin, "Formulation development of a stable, orally delivered live human neonatal rotavirus(rv3-bb) vaccine candidate" in "Vaccine Technology VII", Amine Kamen, McGill University Tarit Mukhopadhyay, University College London Nathalie Garcon, Bioaster Charles Lutsch, Sanofi Pasteur Eds, ECI Symposium Series, (2018). http://dc.engconfintl.org/vt_vii/24