ArticleHuman vaccines & immunotherapeutics2021
Formulation development of a live attenuated human rotavirus (RV3-BB) vaccine candidate for use in low- and middle-income countries.
Article in Human vaccines & immunotherapeutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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Who cites it
8 citing papers in PubMed.
- Polypeptide Sequence Effects on Virus Thermostability in Complex Coacervate Formulations.Biomacromolecules · 2026Article
- A Comprehensive Analysis of Biopharmaceutical Products Listed in the FDA's Purple Book.AAPS PharmSciTech · 2024Review
- Correlating physicochemical and biological properties to define critical quality attributes of a rAAV vaccine candidate.Molecular therapy. Methods & clinical development · 2023Article
- Expression and Purification of Porcine Rotavirus Structural Proteins in Silkworm Larvae as a Vaccine Candidate.Molecular biotechnology · 2023Article
- 14th International dsRNA Virus Symposium, Banff, Alberta, Canada, 10-14 October 2022.Virus research · 2023Article
- Current and next-generation formulation strategies for inactivated polio vaccines to lower costs, increase coverage, and facilitate polio eradication.Human vaccines & immunotherapeutics · 2022Review
- Developing a manufacturing process to deliver a cost effective and stable liquid human rotavirus vaccine.Vaccine · 2021Article
- Effect of Formulation Variables on the Stability of a Live, Rotavirus (RV3-BB) Vaccine Candidate using in vitro Gastric Digestion Models to Mimic Oral Delivery.Journal of pharmaceutical sciences · 2021Article
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Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
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 pharmaceutical excipients were screened for their ability to stabilize RV3-BB during exposure to elevated temperatures, freeze-thaw and agitation stresses. Sucrose (50-60% w/v), PEG-3350, and a solution pH of 7.8 were selected as promising stabilizers. Using a combination of an
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