Song Xue, Ren Xiumei, Song Yang, Yang Shengbao, Lu Kailang, Zhang Yan, Liu Jiankai
Beijing Minhai Biotechnology Co., Ltd., Beijing 102609, China.
Vaccines (Basel). 2025 Aug 20;13(8):879. doi: 10.3390/vaccines13080879.
: 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.
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。