Objective To analyze the safety and consistency of domestic live attenuated varicella vaccines (LAVVs) at gene level.Methods The key genes (ORF38,ORF54,and ORF62) of LAVVs produced by four Chinese manufacturers were amplified by polymerase chain reaction (PCR) and sequenced.The sequencing results were compared with the sequences of Dumas,P-Oka,and V-Oka strains in GenBank and with the sequences of Varilrix (GSK) and Varivax (Merck).Results The ORF38 and ORF54 gene sequences of four domestic LAVVs were the same as each other and completely consistent with the sequences of V-Oka and Varilrix;however,it was different from Varivax (Merck) at one site.The ORF62 gene sequences of four domestic LAVVs were similar,and had individual nucleotide differences with V-Oka,Varilrix(GSK),and Varivax (Merck).Conclusions The sequences of ORF38,ORF54,and ORF62 of four domestic LAVVs are almost the same,showing good stability.They have small differences with V-Oka,Varilrix(GSK),and Varivax (Merck),without introducing new mutations.
目的 从基因水平分析国产水痘减毒活疫苗的安全性和一致性。方法 对国内4家企业生产的水痘减毒活疫苗的关键基因(ORF38、ORF54和ORF62)进行PCR扩增和序列测定,并与Genbank公布的Dumas、P-Oka、V-Oka及国外上市疫苗Varilrix(GSK)、Varivax(Merck)的序列进行比对。结果 4家国产水痘减毒活疫苗的ORF38和ORF54区基因序列一致,并且同V-Oka、Varilrix完全一致,与Varivax(Merck)有1处差异。4家国产水痘减毒活疫苗的ORF62区基因序列基本一致,与V-Oka、Varilrix(GSK)和Varivax(Merck)均存在个别核苷酸差异。结论 4家国产水痘减毒活疫苗的ORF38、ORF54和ORF62区基因序列基本一致,稳定性较好,与V-Oka、Varilrix(GSK)和Varivax(Merck)存在较小差异,没有引入新的突变位点。.