Establishment of Sandwich ELISA for Quality Control in Rotavirus Vaccine Production

Non-replicating rotavirus vaccines are alternative strategies that may improve the protective efficacy of rotavirus vaccines in low- and middle-income countries. The truncated spike protein VP4 (aa26-476, VP4*)was a candidate antigen for the development of recombinant rotavirus vaccines, with higher...

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Bibliographic Details
Main Authors: Cao Li, Guoxing Luo, Yuanjun Zeng, Feibo Song, Han Yang, Shiyin Zhang, Yingbin Wang, Tingdong Li, Shengxiang Ge, Ningshao Xia
Format: Article
Language:English
Published: MDPI AG 2022-02-01
Series:Vaccines
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Online Access:https://www.mdpi.com/2076-393X/10/2/243
Description
Summary:Non-replicating rotavirus vaccines are alternative strategies that may improve the protective efficacy of rotavirus vaccines in low- and middle-income countries. The truncated spike protein VP4 (aa26-476, VP4*)was a candidate antigen for the development of recombinant rotavirus vaccines, with higher immunogenicity and protective efficacy compared to VP8* and VP5* alone. This article describes the development of three genotype-specific sandwich ELISAs for P[4], P[6], and P[8]-VP4*, which are important for quality control in rotavirus vaccine production. Our results showed that the detection systems had good specificity for the different genotype VP4* and were not influenced by the <i>E. coli</i> host proteins. Moreover, the detection systems play an important role in determining whether the target protein was contaminated by VP4* proteins of other genotypes. They can also detect the adsorption rate of the adjuvant to the P[4], P[6], P[8]-VP4* protein during the process development. The three detection systems will play an important role in the quality control and process development of VP4* based rotavirus vaccines and facilitate the development of recombinant rotavirus vaccines.
ISSN:2076-393X