Zou Wenqi, Yu Qingchuan, Liu Yan, Li Qingliang, Chen Hong, Gao Jiamei, Shi Chen, Wang Ying, Chen Wei, Bai Xuan, Yang Biao, Zhang Jiuwei, Dong Ben, Ruan Bo, Zhou Liuyifan, Xu Gelin, Hu Zhongyu, Yang Xiaoming
National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co., Ltd, Wuhan, 430207, China.
National Institutes for Food and Drug Control, Beijing, 100050, China.
Virol Sin. 2023 Dec;38(6):889-899. doi: 10.1016/j.virs.2023.11.002. Epub 2023 Nov 14.
The oral hexavalent live human-bovine reassortant rotavirus vaccine (RV6) developed by Wuhan Institute of Biological Products Co., Ltd (WIBP) has finished a randomized, placebo-controlled phase III clinical trial in four provinces of China in 2021. The trail demonstrated that RV6 has a high vaccine efficacy against the prevalent strains and is safe for use in infants. During the phase III clinical trial (2019-2021), 200 rotavirus-positive fecal samples from children with RV gastroenteritis (RVGE) were further studied. Using reverse transcription-polymerase chain reaction and high-throughput sequencing, VP7 and VP4 sequences were obtained and their genetic characteristics, as well as the differences in antigenic epitopes of VP7, were analyzed in detail. Seven rotavirus genotypes were identified. The predominant rotavirus genotype was G9P [8] (77.0%), followed by prevalent strains G8P [8] (8.0%), G3P [8] (3.5%), G3P [9] (1.5%), G1P [8] (1.0%), G2P [4] (1.0%), and G4P [6] (1.0%). The amino acid sequence identities of G1, G2, G3, G4, G8, and G9 genotypes of isolates compared to the vaccine strains were 98.8%, 98.2%-99.7%, 88.4%-99.4%, 98.2%, 94.2%-100%, and 93.9%-100%, respectively. Notably, the vaccine strains exhibited high similarity in amino acid sequence, with only minor differences in antigenic epitopes compared to the Chinese endemic strains. This supports the potential application of the vaccine in preventing diseases caused by rotaviruses.
武汉生物制品研究所有限责任公司（WIBP）研发的口服六价人-牛重配轮状病毒疫苗（RV6）于2021年在中国四个省份完成了一项随机、安慰剂对照的III期临床试验。该试验表明，RV6对流行毒株具有高疫苗效力，且用于婴儿是安全的。在III期临床试验（2019 - 2021年）期间，对200份轮状病毒阳性的轮状病毒胃肠炎（RVGE）患儿粪便样本进行了进一步研究。使用逆转录-聚合酶链反应和高通量测序，获得了VP7和VP4序列，并详细分析了它们的遗传特征以及VP7抗原表位的差异。鉴定出7种轮状病毒基因型。主要的轮状病毒基因型是G9P[8]（77.0%），其次是流行毒株G8P[8]（8.0%）、G3P[8]（3.5%）、G3P[9]（1.5%）、G1P[8]（1.0%）、G2P[4]（1.0%）和G4P[6]（1.0%）。与疫苗株相比，分离株的G1、G2、G3、G4、G8和G9基因型的氨基酸序列同一性分别为98.8%、98.2% - 99.7%、88.4% - 99.4%、98.2%、94.2% - 100%和93.9% - 100%。值得注意的是，疫苗株在氨基酸序列上表现出高度相似性，与中国流行株相比，抗原表位仅有微小差异。这支持了该疫苗在预防轮状病毒引起的疾病方面的潜在应用。
