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We are proud to announce a fourth publication coming from our rotavirus vaccine project, funded by the Bill & Melinda Gates Foundation. The journal Biologicals has published scientific data generated together with the University of Kansas on the modeling of the long-term 2-8 °C stability profiles of a live, neonatal rotavirus vaccine candidate (RV3-BB) in various liquid formulations via extrapolations of real-time and accelerated stability data.

Wilfried Bakker (Director Science & Innovation at Batavia Biosciences) comments: “We are proud to contribute to science with our projects. It is our mission to reduce human suffering from infectious diseases by deploying our expertise and experience to improve the availability and accessibility of vaccines.”

To accelerate the formulation development of live-virus vaccine candidates, more rapid approaches to rank-order formulations and estimate their real-time storage stability losses are needed. In this case-study, we utilize new and previously described stability data of a live, rotavirus vaccine candidate to model and compare predicted vs. experimental stability profiles.

We are proud to share that good correlations of modeled versus experimental stability data were achieved by employing (1) a high-throughput RT-qPCR assay to measure viral titers, (2) additional assay replicates and stability time-points, and (3) a −80 °C control for each formulation to benchmark results at each stability time-point and temperature.

Instead of accumulating two-year, 2–8 °C storage stability data, the same rank-ordering of the three RV3-BB formulations could have been achieved by modeling 37°, 25°, 15° (and 2–8 °C) stability data over 1, 3 and 12 months, respectively. The results of this case-study are very promising for accelerating future live-virus vaccine candidates formulation development.

About the RV3-BB vaccine

The RV3-BB human neonatal rotavirus vaccine was developed at the Murdoch Children’s Research Institute. The live-attenuated vaccine candidate provides protection from severe rotavirus disease from birth. Due to an earlier peak age of disease in high-mortality settings, the vaccine is tested in a neonatal schedule. In a recent randomized placebo-controlled efficacy study conducted in Central Java and Yogyakarta, Indonesia, three doses of RV3-BB in Indonesian infants resulted in 75% efficacy against severe rotavirus gastroenteritis in the first 18 months of life when administered in a neonatal schedule. This is a significantly higher efficacy than that seen with currently marketed rotavirus vaccines.

This project was funded by a grant from the Bill & Melinda Gates Foundation (#OPP1148427) aimed to accelerate the development of a low-cost, liquid RV3-BB rotavirus vaccine for Gavi-eligible countries through formulation development and bulk process optimization.