Sabin IPV疫苗在版纳小耳猪体内的免疫原性及安全性研究
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摘要
目的评价Sabin株脊髓灰质炎灭活疫苗(inactivated poliovirus vaccine derived from Sabin strain,s IPV)在版纳小耳猪体内的免疫原性及安全性,为新型动物模型提供实验依据。方法采用中国医学科学院医学生物学研究所已经上市的s IPV疫苗,设计s IPV肌肉免疫实验组与野毒株IPV(IPV derived from wild strain,w IPV)肌肉免疫对照组,以及生理盐水阴性对照组,按0、1、2月基础免疫程序,接种版纳小耳猪,于免疫接种前及每剂免疫接种后第30天釆血,检测各组的血清中和抗体水平,评价免疫原性,并通过观察小耳猪的状态及体重情况,评价安全性。结果版纳小耳猪3剂免疫后,s IPV试验组与w IPV对照组Ⅰ、Ⅱ、Ⅲ型抗体阳转率均达到了100%,各型中和抗体几何平均滴度(GMT)均远高于1∶8保护水平。版纳小耳猪接种疫苗后体重增加,结果表明s IPV疫苗在版纳小耳猪动物模型中具有良好的安全性。结论 s IPV疫苗在版纳小耳猪体内具有良好的免疫原性及安全性,版纳小耳猪可作为评价s IPV疫苗的新型实验动物模型。
Objective To evaluate the immunogenicity and safety of inactivated poliovirus vaccine derived from Sabin strain( s IPV) in Banna mini pigs,and to provide experimental evidence for the new animal model. Methods s IPV vaccines which are listed at Institute of Medical Biology at Chinese Academy of Medical Sciences were used in this study.The groups of intramuscular s IPV and the wild strain IPV injections( IPV derived from wild strain,w IPV) were designed,and the saline group was used as a negative control group. The Banna mini pigs in various groups were immunized at 0,1 and 2 months. Blood samples were collected before immunization and on days 30 after each immunization. Levels of neutralizing antibodies were tested for evaluating immunogenicity. The safety was evaluated by observation of the status and weight of mini pigs. Results After the three dose immunization schedules in the Banna mini pigs,the seroconversion ratesof type I,II and III s IPV experimental groups and w IPV group were all up to 100%. The neutralizing antibody levels in all the three types were much higher than the protective titer 1: 8. The weight of mini pigs increased after vaccination.Conclusions The s IPV vaccine has good immunogenicity and safety in Banna mini pigs. Banna mini pigs could be a new animal model for evaluation of s IPV vaccine.
Objective To evaluate the immunogenicity and safety of inactivated poliovirus vaccine derived from Sabin strain( s IPV) in Banna mini pigs,and to provide experimental evidence for the new animal model. Methods s IPV vaccines which are listed at Institute of Medical Biology at Chinese Academy of Medical Sciences were used in this study.The groups of intramuscular s IPV and the wild strain IPV injections( IPV derived from wild strain,w IPV) were designed,and the saline group was used as a negative control group. The Banna mini pigs in various groups were immunized at 0,1 and 2 months. Blood samples were collected before immunization and on days 30 after each immunization. Levels of neutralizing antibodies were tested for evaluating immunogenicity. The safety was evaluated by observation of the status and weight of mini pigs. Results After the three dose immunization schedules in the Banna mini pigs,the seroconversion ratesof type I,II and III s IPV experimental groups and w IPV group were all up to 100%. The neutralizing antibody levels in all the three types were much higher than the protective titer 1: 8. The weight of mini pigs increased after vaccination.Conclusions The s IPV vaccine has good immunogenicity and safety in Banna mini pigs. Banna mini pigs could be a new animal model for evaluation of s IPV vaccine.
引文
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[14]Klein P,Sojka M,Kucera J,et al.A porcine model of skin wound infected with a polybacterial biofilm[J].Biofouling,2018,34(2):226-236.
[2]Foiadelli T,Savasta S,Battistone A,et al.Nucleotide variation in Sabin type 3 poliovirus from an Albanian infant with agammaglobulinemia and vaccine associated poliomyelitis[J].BMC Infect Dis,2016,16:277.
[3]Gomber S,Arora V,Dewan P.Vaccine associated paralytic poliomyelitis unmasking common variable immunodeficiency[J].Indian Pediatr,2017,54(3):241-242.
[4]Sun M,Li C,Xu W,et al.Immune serum from Sabin inactivated poliovirus vaccine immunization neutralizes multiple individual wild and vaccine-derived polioviruses[J].Clin Infect Dis,2017,64(10):1317-1325.
[5]Someya Y,Ami Y,Takai-Todaka R,et al.Evaluation of the use of various rat strains for immunogenic potency tests of Sabinderived inactivated polio vaccines[J].Biologicals,2018,52:12-17.
[6]World Health Organization.Polio vaccines:WHO position paper,March 2016-recommendatio-ns[J].Vaccine,2017,35(9):1197-1199.
[7]WHO(2013)Meeting of the Strategic Advisory Group of Experts on Immunization[C].November 2012-conclusions and recommendations[J].Wkly Epidemiol Rec,88:1-16.
[8]Catry J,Luong-Nguyen M,Arakelian L,et al.Circumferential esophageal replacement by a tissue-engineered substitute using mesenchymal stem cells:An experimental study in mini pigs[J].Cell Transplant,2017,26(12):1831-1839.
[9]Ferreira A,Marques P,Ribeiro B,et al.Combining biotechnology with circular bioeconomy:From poultry,swine,cattle,brewery,dairy and urban wastewaters to biohydrogen[J].Environ Res,2018,164:32-38.
[10]World Health Organization.Manual for the virological investigation of polio[A].WHO/EPI/GEN 97.01.1997.
[11]姜述德,David Pye.应用微量中和抑制法测定脊髓灰质炎灭活疫苗的抗原性[J].中国医学科学院学报.1985,7:309-312.Jiang SD,Pye D.Determination of antigenicity of poliomyelitis inactivated vaccine by microneutralization inhibition[J].J Chin Acad Med Sci,1985,7:309-312.
[12]Liao G,Li R,Li C,et al.Phase 3 trial of a Sabin strain-based inactivated poliovirus vaccine[J].J Infect Dis,2016,214(11):1728-1734.
[13]魏鸿.我国小型猪研究现状[J].中国实验动物学杂志.1997,7(4):252-255.Wei H.Research status of mini pigs in China[J].Chin J Laboratory Animal Sci,1997,7(4):252-255.
[14]Klein P,Sojka M,Kucera J,et al.A porcine model of skin wound infected with a polybacterial biofilm[J].Biofouling,2018,34(2):226-236.