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狂犬病暴露后使用"2-1-1"程序接种人用狂犬病疫苗(Vero细胞)3年免疫持久性及2剂加强免疫效果观察

黄竹航,  苏家立,  郑慧贞,  张怡滨,  汤妍,  夏艳辉,  陈义建,  张磊,  范仁锋,  张吉凯

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文章导航 > 中华疾病控制杂志  > 2019 >  23(5): 607-612
黄竹航, 苏家立, 郑慧贞, 张怡滨, 汤妍, 夏艳辉, 陈义建, 张磊, 范仁锋, 张吉凯. 狂犬病暴露后使用'2-1-1'程序接种人用狂犬病疫苗(Vero细胞)3年免疫持久性及2剂加强免疫效果观察[J]. 中华疾病控制杂志, 2019, 23(5): 607-612. doi: 10.16462/j.cnki.zhjbkz.2019.05.023
引用本文: 黄竹航, 苏家立, 郑慧贞, 张怡滨, 汤妍, 夏艳辉, 陈义建, 张磊, 范仁锋, 张吉凯. 狂犬病暴露后使用"2-1-1"程序接种人用狂犬病疫苗(Vero细胞)3年免疫持久性及2剂加强免疫效果观察[J]. 中华疾病控制杂志, 2019, 23(5): 607-612. doi: 10.16462/j.cnki.zhjbkz.2019.05.023
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HUANG Zhu-hang, SU Jia-li, ZHENG Hui-zhen, ZHANG Yi-bin, TANG Yan, XIA Yan-hui, CHEN Yi-jian, ZHANG Lei, FAN Ren-feng, ZHANG Ji-kai. Persistence of rabies antibody 3 years after postexposure prophylaxis with 2-1-1 regimen of Vero-cell rabies vaccine for human use and antibody response to two booster doses[J]. CHINESE JOURNAL OF DISEASE CONTROL & PREVENTION, 2019, 23(5): 607-612. doi: 10.16462/j.cnki.zhjbkz.2019.05.023
Citation: HUANG Zhu-hang, SU Jia-li, ZHENG Hui-zhen, ZHANG Yi-bin, TANG Yan, XIA Yan-hui, CHEN Yi-jian, ZHANG Lei, FAN Ren-feng, ZHANG Ji-kai. Persistence of rabies antibody 3 years after postexposure prophylaxis with 2-1-1 regimen of Vero-cell rabies vaccine for human use and antibody response to two booster doses[J]. CHINESE JOURNAL OF DISEASE CONTROL & PREVENTION, 2019, 23(5): 607-612. doi: 10.16462/j.cnki.zhjbkz.2019.05.023
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狂犬病暴露后使用"2-1-1"程序接种人用狂犬病疫苗(Vero细胞)3年免疫持久性及2剂加强免疫效果观察

doi: 10.16462/j.cnki.zhjbkz.2019.05.023
  • 1.

    510440 广州, 广东省生物制品与药物研究所生物制品监测评价室

  • 2.

    511430 广州, 广东省疾病预防控制中心传染病预防控制所

  • 3.

    110179 沈阳, 辽宁成大生物股份有限公司医学市场部

基金项目: 

广东省疫苗临床研究技术服务平台 Guangdong provincial development and reform commission[2016] No. 779

广东省实验室体系建设专项资金 Guangdong province vaccine safety key scientific research base, 2012A061300003

广州市疫苗安全性评价重点实验室建设专项资金 2014SY000009

广东省医学科学技术研究基金项目 B2016009

详细信息
    通讯作者:

    张吉凯, E-mail: 527929822@qq.com

  • 中图分类号: R512.2;R181

Persistence of rabies antibody 3 years after postexposure prophylaxis with 2-1-1 regimen of Vero-cell rabies vaccine for human use and antibody response to two booster doses

  • 1.

    Guangdong Provincial Institute of Biological Products and Materia Medica, Department of Biological Products Surveillance and Evaluation, Guangzhou 510440, China

  • 2.

    Guangdong Provincial Center for Disease Control and Prevention, Institute for Infectious Disease Control and Prevention, Guangzhou 511430, China

  • 3.

    Liaoning Chengda Biological Limited by Share Ltd, Department of Medical Market, Shenyang 110179, China

Funds: 

Guangdong technology service platform for clinical research on vaccines Guangdong provincial development and reform commission[2016] No. 779

Guangdong province laboratory system construction special funds Guangdong province vaccine safety key scientific research base, 2012A061300003

Guangzhou vaccine safety evaluation of key laboratory special funds 2014SY000009

Guangdong province medical science and technology research fund project B2016009

More Information

    摘要
  • 摘要:   目的  评价使用"2-1-1"程序接种狂犬病疫苗的免疫持久性及2剂加强免疫效果。  方法  选择曾暴露后使用"2-1-1"程序后1年、2年和3年的对象314人，进行2剂加强免疫，在加强免疫前、后14天分别采集血清，采用酶联免疫吸附实验(enzyme linked immunosorbent assay，ELISA)法检测人狂犬病毒IgG抗体，分析使用"2-1-1"程序后1年、2年、3年及经2剂加强免疫后的抗体几何平均浓度(geometric mean concentration，GMC)和抗体阳性率。  结果  303人按"2-1-1"程序接种疫苗后1年、2年和3年的抗体GMC分别为1.33 IU/mL、1.04 IU/mL和0.72 IU/mL，抗体阳性率分别为77.78%、66.67%和55.56%。282人经2剂加强免疫后，1年组、2年组和3年组的抗体GMC分别为16.83 IU/mL、19.37 IU/mL和21.05 IU/mL，加强免疫后抗体GMC均高于加强免疫前(t=16.54，P < 0.001；t=13.85，P < 0.001；t=16.02，P < 0.001)；抗体阳性率分别为100.00%、99.00%和100.00%。  结论  狂犬病暴露后使用"2-1-1"程序具有良好的免疫持久性，3年内2剂次加强免疫后具有较好的免疫应答。
    Abstract:   Objective  To evaluate the antibody persistence following rabies postexposure prophylaxis (PEP) with 2-1-1 regimen and antibody response to two booster doses.  Methods  A total of 314 healthy volunteers at year 1, year 2, year 3 who had received a complete rabies PEP using 2-1-1 regimen were recruited. Two booster doses of rabies vaccine were inoculated, and blood samples were obtained before and 14 days after two booster doses. Human rabies virus IgG antibody was evaluated by ELISA, and the antibody levels and antibody positive rates were analyzed.  Results  The antibody GMC of 303 people at year 1, year 2, year 3 after a complete immunization was 1.33 IU/mL, 1.04 IU/mL and 0.72 IU/mL, with an antibody positive rate of 77.78%, 66.67% and 55.56%, respectively. Among 282 people who received 2 doses for booster immunization, the antibody GMC at day 14 of 1 year, 2 year and 3 year immunization group was 16.83 IU/mL, 19.37 IU/mL and 21.05 IU/mL respectively, which was higher than that before booster immunization (t=16.54, P < 0.001; t=13.85, P < 0.001; t=16.02, P < 0.001). The antibody positive rate was 100.00%, 99.00% and 100.00%, respectively.  Conclusions  The immune persistence of rabies antibody after PEP with antirabies vaccine using the 2-1-1 regimen is good so as to the immune response after 2 doses of booster immunization in 3 years is effective.
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  • 表  1  受试者加强免疫前狂犬病毒IgG抗体水平

    Table  1.   The IgG antibody levels in rabies virus before booster immunizations

    性别 1年组 2年组 3年组
    检测数(人) GMC(IU/mL) 95%CI值 检测数(人) GMC(IU/mL) 95%CI值 检测数(人) GMC(IU/mL) 95%CI值
    男性
      18~岁 19 1.59 0.94~2.69 17 0.73 0.14~3.90 14 1.44 0.50~4.13
      31~岁 19 1.96 1.12~3.41 18 0.68 0.27~1.68 17 0.50 0.20~1.25
      41~岁 20 0.72 0.29~1.79 18 0.67 0.17~2.67 17 0.70 0.26~1.92
      小计 58 1.30 0.88~1.92 53 0.69 0.33~1.42 48 0.77 0.45~1.32
    女性
      18~岁 17 1.38 0.64~3.01 16 1.15 0.53~2.50 1 0.39
      31~岁 18 1.07 0.63~1.81 19 1.34 0.62~2.88 17 0.99 0.56~2.17
      41~岁 15 1.84 0.87~3.91 17 2.62 1.44~4.77 24 0.52 0.25~1.07
      小计 50 1.38 0.95~1.99 52 1.59 1.07~2.38 42 0.67 0.40~1.11
    合计
      18~岁 36 1.49 0.96~2.30 33 0.91 0.37~2.22 15 1.32 0.49~3.56
      31~岁 37 1.46 1.00~2.13 37 0.96 0.54~1.70 34 0.70 0.40~1.26
      41~岁 35 1.08 0.59~1.97 35 1.30 0.60~2.80 41 0.59 0.33~1.04
      小计 108 1.33 1.02~1.74 105 1.04 0.69~1.58 90 0.72 0.50~1.04
    下载: 导出CSV

    表  2  受试者加强免疫前狂犬病毒IgG抗体阳性率

    Table  2.   The positive rate of IgG antibody in rabies virus before booster immunizations

    性别 1年组 2年组 3年组
    检测数(人) 阳性数(人) 阳性率(%) 检测数(人) 阳性数(人) 阳性率(%) 检测数(人) 阳性数(人) 阳性率(%)
    男性
      18~岁 19 16 84.21 17 12 70.59 14 9 64.29
      31~岁 19 18 94.74 18 9 50.00 17 7 41.18
      41~岁 20 10 50.00 18 9 50.00 17 10 58.82
      小计 58 44 75.86 53 30 56.60 48 26 54.17
    女性
      18~岁 17 14 68.75 16 11 68.75 1 0 0.00
      31~岁 18 14 68.42 19 13 68.42 17 11 64.71
      41~岁 15 12 94.12 17 16 94.12 24 13 54.17
      小计 50 40 76.92 52 40 76.92 42 24 57.14
    合计
      18~岁 36 30 83.33 33 23 69.70 15 9 60.00
      31~岁 37 32 86.49 37 22 59.46 34 18 52.94
      41~岁 35 22 62.86 35 25 71.43 41 23 56.10
      小计 108 84 77.78 105 70 66.67 90 50 55.56
    下载: 导出CSV

    表  3  受试者加强免疫后狂犬病毒IgG抗体水平

    Table  3.   The IgG antibody levels in rabies virus after booster immunizations

    性别 1年组 2年组 3年组
    检测数(人) GMC(IU/mL) 95%CI值 检测数(人) GMC(IU/mL) 95%CI值 检测数(人) GMC(IU/mL) 95%CI值
    男性(岁)
      18~ 18 18.44 11.95~28.46 16 31.30 17.67~55.46 13 29.32 18.95~45.38
      31~ 16 11.79 8.13~17.12 16 18.31 10.54~31.82 16 23.71 13.33~42.20
      41~ 19 12.56 9.03~17.47 17 20.53 9.07~46.47 17 16.05 11.26~22.86
      小计 53 14.04 11.36~17.36 50 22.60 15.76~32.40 46 21.79 16.82~28.24
    女性(岁)
      18~ 16 22.91 13.38~39.21 16 16.23 9.65~27.28 1 69.30 -
      31~ 17 23.05 14.20~37.43 19 13.56 9.01~20.42 16 25.89 15.80~42.41
      41~ 14 16.03 15.74~27.06 15 21.96 13.06~36.95 19 15.28 9.65~24.19
      小计 47 20.64 15.74~27.06 50 16.60 12.78~21.56 36 20.14 14.49~28.01
    合计(岁)
      18~ 34 20.42 14.76~28.26 32 22.54 15.36~33.06 14 31.18 20.44~47.56
      31~ 33 16.66 12.16~22.82 36 15.63 11.29~21.63 32 24.78 17.33~35.42
      41~ 33 13.93 10.73~18.08 32 21.19 13.24~33.92 36 15.64 11.82~20.69
      小计 100 16.83 14.18~19.97 100 19.37 15.53~24.15 82 21.05 17.22~25.73
    下载: 导出CSV

    表  4  受试者加强免疫后狂犬病毒IgG抗体阳性率

    Table  4.   The positive rate of IgG antibody in rabies virus after booster immunizations

    性别 1年组 2年组 3年组
    检测数(人) 阳性数(人) 阳性率(%) 检测数(人) 阳性数(人) 阳性率(%) 检测数(人) 阳性数(人) 阳性率(%)
    男性(岁)
      18~ 18 18 100.00 16 16 100.00 13 13 100.00
      31~ 16 16 100.00 16 17 100.00 16 16 100.00
      41~ 19 19 100.00 17 16 94.12 17 17 100.00
      小计 53 53 100.00 50 49 98.00 46 46 100.00
    女性(岁)
      18~ 16 16 100.00 16 16 100.00 1 1 100.00
      31~ 17 17 100.00 19 19 100.00 16 16 100.00
      41~ 14 14 100.00 15 15 100.00 19 19 100.00
      小计 47 47 100.00 50 50 100.00 36 36 100.00
    合计(岁)
      18~ 34 34 100.00 32 32 100.00 14 14 100.00
      31~ 33 33 100.00 36 36 100.00 32 32 100.00
      41~ 33 33 100.00 32 31 96.88 36 36 100.00
      小计 100 100 100.00 100 99 99.00 82 82 100.00
    下载: 导出CSV
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