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Sabin株脊髓灰质炎灭活疫苗与不同剂型Ⅰ型Ⅲ型脊髓灰质炎减毒活疫苗序贯接种的抗体滴度比较

赵志梅,  黄腾,  李国良,  杨晓蕾,  蒋蕊鞠,  叶慧,  赵婷,  李菁,  刘小畅,  傅宇婷,  施红媛,  周海军,  莫兆军,  车艳春,  杨净思

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文章导航 > 中华疾病控制杂志  > 2019 >  23(4): 402-406
赵志梅, 黄腾, 李国良, 杨晓蕾, 蒋蕊鞠, 叶慧, 赵婷, 李菁, 刘小畅, 傅宇婷, 施红媛, 周海军, 莫兆军, 车艳春, 杨净思. Sabin株脊髓灰质炎灭活疫苗与不同剂型Ⅰ型Ⅲ型脊髓灰质炎减毒活疫苗序贯接种的抗体滴度比较[J]. 中华疾病控制杂志, 2019, 23(4): 402-406. doi: 10.16462/j.cnki.zhjbkz.2019.04.007
引用本文: 赵志梅, 黄腾, 李国良, 杨晓蕾, 蒋蕊鞠, 叶慧, 赵婷, 李菁, 刘小畅, 傅宇婷, 施红媛, 周海军, 莫兆军, 车艳春, 杨净思. Sabin株脊髓灰质炎灭活疫苗与不同剂型Ⅰ型Ⅲ型脊髓灰质炎减毒活疫苗序贯接种的抗体滴度比较[J]. 中华疾病控制杂志, 2019, 23(4): 402-406. doi: 10.16462/j.cnki.zhjbkz.2019.04.007
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ZHAO Zhi-mei, HUANG Teng, LI Guo-liang, YANG Xiao-lei, JIANG Rui-ju, YE Hui, ZHAO Ting, LI Jing, LIU Xiao-chang, FU Yu-ting, SHI Hong-yuan, ZHOU Hai-jun, MO Zhao-jun, CHE Yan-chun, YANG Jing-si. Comparing the antibody titers of sequential program of Sabin strain-based inactivated poliovirus vaccine followed by bivalent types 1 and 3 oral poliovirus vaccine in different dosage forms[J]. CHINESE JOURNAL OF DISEASE CONTROL & PREVENTION, 2019, 23(4): 402-406. doi: 10.16462/j.cnki.zhjbkz.2019.04.007
Citation: ZHAO Zhi-mei, HUANG Teng, LI Guo-liang, YANG Xiao-lei, JIANG Rui-ju, YE Hui, ZHAO Ting, LI Jing, LIU Xiao-chang, FU Yu-ting, SHI Hong-yuan, ZHOU Hai-jun, MO Zhao-jun, CHE Yan-chun, YANG Jing-si. Comparing the antibody titers of sequential program of Sabin strain-based inactivated poliovirus vaccine followed by bivalent types 1 and 3 oral poliovirus vaccine in different dosage forms[J]. CHINESE JOURNAL OF DISEASE CONTROL & PREVENTION, 2019, 23(4): 402-406. doi: 10.16462/j.cnki.zhjbkz.2019.04.007
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Sabin株脊髓灰质炎灭活疫苗与不同剂型Ⅰ型Ⅲ型脊髓灰质炎减毒活疫苗序贯接种的抗体滴度比较

doi: 10.16462/j.cnki.zhjbkz.2019.04.007
  • 1.

    650118 昆明, 中国医学科学院北京协和医学院医学生物学研究所

  • 2.

    530028 南宁, 广西壮族自治区疾病预防控制中心疫苗临床研究所

  • 3.

    310008 杭州, 杭州市妇产科医院检验科

基金项目: 

国家十二五"重大新药创制"科技重大专项 2015ZX09101031

云南省重点新产品开发专项 2016BC002

详细信息
    通讯作者:

    杨净思, E-mail: yjs@imbcams.com.cn

    莫兆军, E-mail: mozhj@126.com

    车艳春, E-mail: cheyanchun@imbcams.com.cn

  • 中图分类号: R512.4

Comparing the antibody titers of sequential program of Sabin strain-based inactivated poliovirus vaccine followed by bivalent types 1 and 3 oral poliovirus vaccine in different dosage forms

  • 1.

    Institute of Medical Biology, Chinese Academy of Medical Sciences, Peking Union Medical College, Kunming 650118, China

  • 2.

    Institute of vaccine clinical study, Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention, Nanning 530028, China

  • 3.

    Clinical Laboratory, Hangzhou Women's Hospital, Hangzhou 310008, China

Funds: 

National Major Scientific and Technological Special Project for "Significant New Drugs Development" during 12th Five-year Plan Period 2015ZX09101031

Key New Product Development Project of Yunnan Province 2016BC002

More Information

    摘要
  • 摘要:   目的  比较Sabin株脊髓灰质炎灭活疫苗(Sabin strain-based inactivated poliovirus vaccine，sIPV)与不同剂型Ⅰ型Ⅲ型脊髓灰质炎减毒活疫苗(bivalent types Ⅰ and Ⅲ oral poliovirus vaccine，bOPV)序贯接种的抗体滴度。  方法  选择柳州400名2月龄婴儿，按1：1：1：1随机分为sIPV+2bOPV糖丸、sIPV+2bOPV液体、2sIPV+bOPV糖丸、2sIPV+bOPV液体4组，按0 d、28 d、56 d免疫程序接种疫苗。检测免前、免后28 d脊灰中和抗体滴度。  结果  序贯程序相同时，1剂sIPV糖丸组与液体组免后Ⅰ型抗体滴度分布差异有统计学意义(Z=-2.589，P=0.010)，Ⅱ型(Z=-0.331，P=0.741)和Ⅲ型(Z=-1.556，P=0.120)差异均无统计学意义(均有P>0.05)；2剂sIPV糖丸组与液体组免后Ⅰ型(Z=-1.249，P=0.212)、Ⅱ型(Z=-1.658，P=0.097)和Ⅲ型(Z=-1.436，P=0.151)抗体滴度分布差异均无统计学意义(均有P>0.05)。剂型相同时，2剂sIPV组与1剂sIPV组各型抗体滴度分布差异均有统计学意义(均有P < 0.05)(1剂sIPV液体组与2剂sIPV液体组：Ⅰ型：Z=-2.766，P=0.006；Ⅱ型：Z=-9.137，P < 0.001；Ⅲ型：Z=-5.529，P < 0.001。1剂sIPV糖丸组与2剂sIPV糖丸组：Ⅰ型：Z=-3.748，P < 0.001；Ⅱ型：Z=-7.660，P < 0.001；Ⅲ型：Z=-6.030，P < 0.001)。  结论  bOPV糖丸和液体剂型免疫效果相似，各地接种部门应结合疫苗效果、接种对象特征和人口密度，选择适宜剂型接种；如sIPV供应充足，建议优先选择2剂sIPV序贯程序完成脊灰基础免疫接种。
    Abstract:   Objective  To evaluate the antibody titer distributions after primary vaccination by different sequential schedules of Sabin strain-based inactivated poliovirus vaccine(sIPV) and bivalent oral attenuated live poliomyelitis vaccine against types 1 and 3 (bOPV) in Drug Candy(DC) form or liquid dosage form.  Methods  Eligible infants of 2 months old selected in Liuzhou were assigned randomly in a ratio of 1:1:1:1 to 4 groups as following: sIPV+2bOPV(DC), sIPV+2bOPV(liquid), 2sIPV+bOPV(DC), 2sIPV+bOPV(liquid), and were vaccinated at 0, 28, 56 days. Polio neutralizing antibody titers against poliovirus types 1, 2 and 3 were tested prior to Dose 1 and at 28 days after Dose 3.  Results  The antibody titer distribution for type 1 was statistically different between sIPV+2bOPV(DC) and sIPV+2bOPV(liquid) (Z=-2.589, P=0.010) while no significant differences were detected between the two groups for type 2(Z=-0.331, P=0.741) and type 3(Z=-1.556, P=0.120). There were no significant differences between 2sIPV +bOPV(DC) and 2sIPV+bOPV(liquid) for the distributions(All P>0.05) (type 1:Z=-1.249, P=0.212; type 2:Z=-1.658, P=0.097; type 3:Z=-1.436, P=0.151). In the same dosage forms with different sequential schedules, the antibody titer distributions were significantly different between 2 doses sIPV and 1 dose sIPV groups(All P < 0.05)(sIPV+2bOPV(liquid) vs 2sIPV+bOPV(liquid): type 1:Z=-2.766, P=0.006; type 2:Z=-9.137, P < 0.001; type 3:Z=-5.529, P < 0.001. sIPV+2bOPV(DC) vs 2sIPV+bOPV(DC): type 1:Z=-3.748, P < 0.001; type 2:Z=-7.660, P < 0.001; type 3:Z=-6.030, P < 0.001).  Conclusions  Different dosage forms have similar immune effects, so appropriate dosage forms should be selected for vaccination according to the effectiveness, characteristics of subjects and the population density. In the case of sufficient supply of sIPV, 2 doses sIPV sequential program should be the first choice to complete the primary immunization.
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  • 图  1  免后各组Ⅰ型、Ⅱ型、Ⅲ型抗体滴度逆向累积分布图

    Figure  1.  Reverse poliovirus antibody distribution curves for type 1, type 2 and type 3 at 28 days post-Dose 3

    下载: 全尺寸图片 幻灯片

    表  1  免后各组Ⅰ型抗体滴度分布比较[n(%)]

    Table  1.   Comparison of the neutralizing antibody distributions against poliovirus type 1[n(%)]

    抗体滴度 sIPV+2bOPV糖丸 sIPV+2bOPV液体 2sIPV+bOPV糖丸 2sIPV+bOPV液体
    128~ 0(0.00) 0(0.00) 1(1.14) 1(1.09)
    256~ 3(3.45) 0(0.00) 1(1.14) 1(1.09)
    512~ 2(2.30) 3(3.61) 4(4.55) 2(2.17)
    1 024~ 11(12.64) 6(7.23) 4(4.55) 1(1.09)
    2 048~ 10(11.49) 8(9.64) 6(6.82) 7(7.61)
    4 096~ 34(39.08) 23(27.71) 18(20.45) 16(17.39)
    8 192~ 18(20.69) 27(32.53) 27(30.68) 30(32.61)
    ≥16 384 9(10.34) 16(19.28) 27(30.68) 34(36.96)
    合计 87(100.00) 83(100.00) 88(100.00) 92(100.00)
    注：4组间比较：χ2=29.385，P＜0.001。组间两两比较：sIPV+2bOPV糖丸vs液体Z=-2.589，P=0.010；2sIPV+bOPV糖丸vs液体Z=-1.249，P=0.212；sIPV+2bOPV糖丸vs 2sIPV+bOPV糖丸Z=-3.748，P＜0.001；sIPV+2bOPV液体vs 2sIPV+bOPV液体Z=-2.766，P=0.006。
    下载: 导出CSV

    表  2  免后各组Ⅱ型抗体滴度分布比较[n(%)]

    Table  2.   Comparison of the neutralizing antibody distributions against poliovirus type 2[n(%)]

    抗体滴度 sIPV+2bOPV糖丸 sIPV+2bOPV液体 2sIPV+bOPV糖丸 2sIPV+bOPV液体
    0~ 25(28.74) 23(27.71) 3(3.41) 2(2.17)
    8~ 33(37.93) 35(42.17) 9(10.23) 9(9.78)
    16~ 17(19.54) 16(19.28) 11(12.50) 6(6.52)
    32~ 3(3.45) 6(7.23) 21(23.86) 15(16.30)
    64~ 4(4.60) 2(2.41) 17(19.32) 25(27.17)
    128~ 1(1.15) 0(0.00) 14(15.91) 14(15.22)
    256~ 0(0.00) 0(0.00) 6(6.82) 13(14.13)
    512~ 1(1.15) 0(0.00) 2(2.27) 5(5.43)
    1 024~ 2(2.30) 0(0.00) 1(1.14) 2(2.17)
    2 048~4 096 1(1.15) 1(1.20) 4(4.55) 1(1.09)
    合计 87(100.00) 83(100.00) 88(100.00) 92(100.00)
    注：4组间比较：χ2=142.667，P＜0.001。组间两两比较：sIPV+2bOPV糖丸vs液体Z=-0.331，P=0.741；2sIPV+bOPV糖丸vs液体Z=-1.658，P=0.097；sIPV+2bOPV糖丸vs 2sIPV+bOPV糖丸Z=-7.660，P＜0.001；sIPV+2bOPV液体vs 2sIPV+bOPV液体Z=-9.137，P＜0.001。
    下载: 导出CSV

    表  3  免后各组Ⅲ型抗体滴度分布比较[n(%)]

    Table  3.   Comparison of the neutralizing antibody distributions against poliovirus type 3[n(%)]

    抗体滴度 sIPV+2bOPV糖丸 sIPV+2bOPV液体 2sIPV+bOPV糖丸 2sIPV+bOPV液体
    16~ 0(0.00) 0(0.00) 1(1.14) 0(0.00)
    32~ 0(0.00) 0(0.00) 1(1.14) 1(1.09)
    64~ 1(1.15) 0(0.00) 0(0.00) 0(0.00)
    128~ 2(2.30) 1(1.20) 2(2.27) 1(1.09)
    256~ 5(5.75) 5(6.02) 2(2.27) 3(3.26)
    512~ 26(29.89) 22(26.51) 6(6.82) 4(4.35)
    1 024~ 32(36.78) 24(28.92) 10(11.36) 12(13.04)
    2 048~ 12(13.79) 15(18.07) 29(32.95) 19(20.65)
    4 096~ 7(8.05) 12(14.46) 23(26.14) 35(38.04)
    8 192~ 2(2.30) 4(4.82) 12(13.64) 12(13.04)
    ≥16 384 0(0.00) 0(0.00) 2(2.27) 5(5.43)
    合计 87(100.00) 83(100.00) 88(100.00) 92(100.00)
    注：4组间比较：χ2=70.453，P＜0.001。组间两两比较：sIPV+2bOPV糖丸vs液体Z=-1.556，P=0.120；2sIPV+bOPV糖丸vs液体Z=-1.436，P=0.151；sIPV+2bOPV糖丸vs 2sIPV+bOPV糖丸Z=-6.030，P＜0.001；sIPV+2bOPV液体vs 2sIPV+bOPV液体Z=-5.529，P＜0.001。
    下载: 导出CSV
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  • 收稿日期:  2018-10-21
  • 修回日期:  2019-01-26
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