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目的:评价Sabin株脊髓灰质炎灭活疫苗(Sabin strain inactivated poliomyelitis vaccine,s IPV)的免疫原性。方法:将130只大鼠随机分成13组,分别为无佐剂s IPV原倍(Ⅰ/Ⅱ/Ⅲ型抗原含量为:10 DU/50 DU/30 DU)、3倍、9倍、27倍稀释抗原剂量组、含佐剂s IPV原倍(Ⅰ/Ⅱ/Ⅲ型抗原含量为:10 DU/50 DU/30 DU)、3倍、9倍、27倍稀释抗原剂量组、野毒株脊髓灰质炎灭活疫苗(Conventional inactivated poliomyelitis vaccine,c IPV)原倍(Ⅰ/Ⅱ/Ⅲ型抗原含量为:40 DU/8 DU/32 DU)、3倍、9倍、27倍稀释抗原剂量组和阴性对照组。每组10只,腿部肌内注射,0.5 m L·只-1,免疫两剂,免疫间隔时间为21 d。免疫前、第1剂免疫后21 d眼眶采血、第2剂免疫后21 d心脏穿刺采血,分离血清,采用微量细胞病变抑制法测定血清中抗脊髓灰质炎病毒Ⅰ,Ⅱ,Ⅲ型中和抗体效价,计算无佐剂s IPV和含佐剂s IPV ED50值、并与c IPV进行比较。结果:免疫1剂后,无佐剂s IPV、含佐剂s IPV和c IPV组Ⅰ/Ⅱ/Ⅲ型在不同稀释度时,除含佐剂s IPVⅠ型均为100%阳转率,其他几组均随着抗原稀释度的增加中和抗体的阳转率梯度下降。Ⅰ型无佐剂、含佐剂s IPV ED50分别是c IPV的0.02,0.004倍;Ⅱ型无佐剂、含佐剂s IPV ED50分别是c IPV的26.83,5.55倍;Ⅲ型无佐剂、含佐剂s IPV分别是c IPV的0.24,0.13倍。Ⅰ型含佐剂s IPV组1剂免疫后各剂量组大鼠血清中和抗体显著高于无佐剂s IPV相应剂量组(P<0.05),免疫两剂后,略高于无佐剂组,但没有统计学差异。Ⅱ型含佐剂s IPV各剂量组1剂免疫后大鼠血清中和抗体略高于无佐剂相应剂量组,但仅16.7 DU组存在统计学差异(P<0.05),免疫两剂后,仅50 DU组明显高于无佐剂组(P<0.05)。Ⅲ型含佐剂s IPV各剂量组1剂免疫后大鼠血清中和抗体略高于无佐剂相应剂量组,但均无统计学差异;免疫两剂后,30 DU组和1.1 DU组明显高于相应剂量组(P<0.05)。结论:s IPV免疫原性较好,其中Ⅰ型免疫原性明显优于c IPV、Ⅱ型低于c IPV、Ⅲ型略优于c IPV;Sabin株抗原含量和中和效价存在明显的量效关系;A1(OH)3佐剂可以减少抗原的使用量,提高s IPV疫苗的免疫原性。
Objective: To evaluate the immunogenicity of the Sabin strain inactivated poliomyelitis vaccine (sIPV). Methods: Thirty rats were randomly divided into 13 groups: untreated s IPV primary (10/50/30 DU), 3x, 9x, 27x Dilution antigen group, containing the original s IPV adjuvant (Ⅰ / Ⅱ / Ⅲ antigen content: 10 DU / 50 DU / 30 DU), 3 times, 9 times, 27 times diluted antigen dose group, wild strain of spinal cord The original antigen (40Iu / 8 DU / 32 DU), 3X, 9X and 27X antigen dosage groups of Conventional inactivated poliomyelitis vaccine (c IPV) Negative control group. Each group of 10, intramuscular injection of the leg, 0.5 m L · only -1, two immune, immune interval time of 21 d. Serum samples of anti-poliovirus Ⅰ, Ⅱ and Ⅲ neutralizing antibodies were detected by micro-cytopathic effect inhibition before or after immunization of the first dose on the orbit of mice 21 days after the first immunization. Titers were calculated for the non-adjuvanted s IPV and adjuvanted s IPV ED50 values and compared to c IPV. Results: After immunization with 1 dose, the sIPV without adjuvant, sIPV with adjuvant sIPV and cIPV group Ⅰ / Ⅱ / Ⅲ at different dilutions, except those with adjuvant s IPV Ⅰ type were 100% positive conversion rate, other In each group, the gradient of positive conversion rate of neutralizing antibody decreased with the increase of antigen dilution. Type I non-adjuvant, with adjuvant s IPV ED50 respectively c IPV 0.02,0.004 times; Type II without adjuvant, with adjuvant s IPV ED50 respectively c IPV 26.83,5.55 times; Type III no adjuvant, The IPV with adjuvant was 0.24 and 0.13 times the c IPV, respectively. Serum neutralizing antibodies in each dose group were significantly higher than those in the unadjuvanted s IPV group (P <0.05) after immunization with one dose of adjuvant s IPV group , But no statistical difference. The level of neutralizing antibody in serum of rats with type Ⅱ adjuvant s IPV was slightly higher than that without adjuvant, but there was a significant difference only in 16.7 DU group (P <0.05) Only 50 DU group was significantly higher than the non-adjuvant group (P <0.05). The serum neutralizing antibodies of the rats with type Ⅲ adjuvant s IPV in each dose group were slightly higher than those without adjuvant, but there was no significant difference between the two groups Higher than the corresponding dose group (P <0.05). CONCLUSION: The immunogenicity of sVIP is better than that of cIPV, while that of type II is lower than that of cIPV, while that of type III is slightly better than that of cIPV. There is a significant amount of antigens and neutralizing titers in Sabin A1 (OH) 3 adjuvant can reduce the amount of antigen used and improve the immunogenicity of s IPV vaccine.