Establishment of Sandwich ELISA for Quality Control in Rotavirus Vaccine Production.

Establishment of Sandwich ELISA for Quality Control in Rotavirus Vaccine Production.
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DOI:
10.3390/vaccines10020243
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发表时间:
2022-02-05
期刊:
影响因子:
7.8
通讯作者:
Xia N
Xia N
中科院分区:
医学3区
文献类型:
--
作者:
Li C;Luo G;Zeng Y;Song F;Yang H;Zhang S;Wang Y;Li T;Ge S;Xia N

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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 E. coli 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.
人轮状病毒重组 VP8* 亚基肠外疫苗候选物的构建和表征。
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