| 孔建,丁一新,张连芝,赵月萍,柳燕,周秀英,董春明,李方军,杜桂枝,迮文远.不同国家液体型脊髓灰质炎疫苗的热稳定性及免疫原性[J].Chinese journal of Epidemiology,1993,14(3):151-154 |
| 不同国家液体型脊髓灰质炎疫苗的热稳定性及免疫原性 |
| Thermostability and Immunogenicity of Trivalent Oral Poliovirus Vaccine Produced by Different Countries |
| Received:October 05, 1992 Revised:November 10, 1992 |
| DOI： |
| KeyWord: 脊髓灰质炎疫苗 GMT |
| English Key Word: TOPV GMT |
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| Abstract: |
| 本文报道了中国、南斯拉夫、比利时三国生产的脊髓灰质炎疫苗(TOPV)的热稳定性试验的结果,以及用它们免疫2月龄儿童后的血清学效果。在37℃放置48小时或反复冻融5次后,各国TOPV总滴度降低的幅度均在0.5Log TCID50/0.1ml之内。免疫三次后,血清抗各型脊髓灰质炎病毒抗体的阳转率都达到了95%以上,各组间抗同型病毒抗体阳转率/GMT的差异无统计学上的显著性,与第二次免后一个月时相比,阳转率/GMT均无显著性增高。 |
| English Abstract: |
Hep-2 cell-based microtiter assay system was used to test the titer of TOPV (Sabin strain). Before immunization, the overall potency results of TOPV produced by China, Yugoslavia, and Belgium were 6.38, 6.25, and 5.75 log TCID 50/0.1ml, respectively. After storage at 37℃ for 2 days or after 5 cycles of freezing and thawing, the overall titer of each TOPV reduced less than 0.5 log TCID 50/0.1ml.
A randomized study was conducted in Anhui Province to test the serological difference among the TOPV which were produced by China, Yugoslavia and Belgium.The formulations of the TOPV produced by China and Yugoslavia were 6.0, 5.0, and 5.5 logTCID50/0.1ml of Sabin types 1, 2, and 3, respectively. All of the children in this study were divided into three groups, and children in group A, B, and C received TOPV produced by China, Yugoslavia, and Belgium, respectively. Three doses of TOPV were given to the children in the group at 2, 3, and 4 months of age. The seroconversion rates and geometric mean titers had no significant differences among these groups before immunization. At the end of one month following the 2nd dose, the rates of seroconversion to type 1~3 poliovirus in group A, B, and C were 88%, 98%, 98%, 92%, 98%, 92%; 100%, 100%and96%, respectively. The rate of seroconversion to type 1 poliovirus in group C was higher than those in group A and B. At the end of one month after the third dose, the rates of seroconversion to type 1~3 poliovirus in group A, B, and C were 95%, 100%, 98%; 98%, 98%, 96%; 100%, 100% and 98%, respectively; no significant differences were found among these groups, and there was no significant increase in seroconversion rates and geometric mean titers as compared with those at one month after the second dose. |
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