Journal article

Formulation development of a live attenuated human rotavirus (RV3-BB) vaccine candidate for use in low- and middle-income countries

Prashant Kumar, Ravi S Shukla, Ashaben Patel, Swathi R Pullagurla, Christopher Bird, Oluwadara Ogun, Ozan S Kumru, Ahd Hamidi, Femke Hoeksema, Christopher Yallop, Julie E Bines, Sangeeta B Joshi, David B Volkin

Human Vaccines & Immunotherapeutics | TAYLOR & FRANCIS INC | Published : 2021


Formulation development was performed with the live, attenuated, human neonatal rotavirus vaccine candidate (RV3-BB) with three main objectives to facilitate use in low- and middle- income countries including (1) a liquid, 2-8°C stable vaccine, (2) no necessity for pre-neutralization of gastric acid prior to oral administration of a small-volume dose, and (3) a low-cost vaccine dosage form. Implementation of a high-throughput RT-qPCR viral infectivity assay for RV3-BB, which correlated well with traditional FFA assays in terms of monitoring RV3-BB stability profiles, enabled more rapid and comprehensive formulation development studies. A wide variety of different classes and types of pharmac..

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Awarded by Bill and Melinda Gates Foundation

Awarded by Australian National Health and Medical Research Council

Funding Acknowledgements

The work was funded by Bill and Melinda Gates Foundation [grant #OPP1148427 awarded to Batavia Biosciences, Leiden]. The grant received by Batavia Biosciences aimed at accelerating the development of low-cost, liquid RV3-BB rotavirus vaccine for GAVI countries through formulation development and bulk process optimization for large scale manufacturing. MCRI acknowledges funding from the Bill and Melinda Gates Foundation [OPP1111055 and OPP11183101], the Australian National Health and Medical Research Council [APP491238, APP1012425, APP546496] and the Victorian Government Infrastructure Grant.