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一种新型减毒活腮腺炎疫苗株的研发及生物学特性

Development and Biological Properties of a New Live Attenuated Mumps Vaccine Strain.

作者信息

Song Xue, Ren Xiumei, Song Yang, Yang Shengbao, Lu Kailang, Zhang Yan, Liu Jiankai

机构信息

Beijing Minhai Biotechnology Co., Ltd., Beijing 102609, China.

出版信息

Vaccines (Basel). 2025 Aug 20;13(8):879. doi: 10.3390/vaccines13080879.

Abstract

: This study aimed to develop a new attenuated live mumps vaccine strain and determine its biological properties and effectiveness. : Plaque purification and amplification were performed in chicken embryo cells. Candidate live attenuated mumps MuV-365 strain sequencing was performed. After evaluating the potential neurotoxicity of the MuV-365 mumps strain, a preclinical safety evaluation of measles-mumps-rubella (MMR) live attenuated vaccine containing the MuV-365 strain was performed to support the registration and application of the MMR vaccine. Finally, mumps neutralization antibody titers and the concentration of anti-serum mumps-specific IgG were determined to evaluate the immunogenicity and efficacy of the MuV-365 strain and MMR vaccine in mice and rhesus monkeys. : The plaque of the PL-KUM main seed virus was screened, and strains whose sequences were highly homologous to RIT4385 (JL-5 derived) were selected to amplify. The candidate live attenuated mumps MuV-365 strain was then developed. Safety evaluation results indicated that the MuV-365 strain had no potential neurotoxicity, and the MMR vaccine containing the MuV-365 strain also showed no significant safety hazard. The immunogenicity of MuV-365 strain in BALB/c mice was not inferior to S79 and PL-KUM. After two doses of the MuV-365 strain, the concentration of anti-serum mumps-specific IgG of the MuV-365 strain was significantly higher than that of the S79 strain ( < 0.01). In rhesus monkeys, the MMR vaccine had good immunogenicity against measles and rubella after one dose, while immunogenicity against mumps improved after two doses. : The developed MuV-365 strain was genetically stable, with adequate safety and immunogenicity.

摘要

本研究旨在研发一种新型减毒活腮腺炎疫苗株,并确定其生物学特性和有效性。在鸡胚细胞中进行蚀斑纯化和扩增。对候选减毒活腮腺炎MuV-365株进行测序。在评估MuV-365腮腺炎株的潜在神经毒性后,对含MuV-365株的麻疹-腮腺炎-风疹(MMR)减毒活疫苗进行临床前安全性评估,以支持MMR疫苗的注册和应用。最后,测定腮腺炎中和抗体滴度和抗血清腮腺炎特异性IgG浓度,以评估MuV-365株和MMR疫苗在小鼠和恒河猴中的免疫原性和效力。筛选PL-KUM主种子病毒的蚀斑,选择与RIT4385(源自JL-5)序列高度同源的毒株进行扩增。随后研发出候选减毒活腮腺炎MuV-365株。安全性评估结果表明,MuV-365株无潜在神经毒性,含MuV-365株的MMR疫苗也未显示出明显的安全隐患。MuV-365株在BALB/c小鼠中的免疫原性不低于S79和PL-KUM。接种两剂MuV-365株后,MuV-365株抗血清腮腺炎特异性IgG浓度显著高于S79株(<0.01)。在恒河猴中,一剂MMR疫苗对麻疹和风疹具有良好的免疫原性,而两剂后对腮腺炎的免疫原性有所提高。研发的MuV-365株遗传稳定,具有足够的安全性和免疫原性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3c1f/12389834/5cb8bff4de5f/vaccines-13-00879-g001.jpg

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