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

Abstract

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..

View full abstract

Grants

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.