国内脊髓灰质炎疫苗不同序贯免疫程序免疫效果及安全性的研究进展
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摘要
口服脊髓灰质炎减毒活疫苗(oral poliomyelitis attenuated live vaccine,OPV)和脊髓灰质炎灭活疫苗(inactivated poliomyelitis vaccine,IPV)的实施在消灭脊髓灰质炎(poliomyelitis)中发挥了重要作用,但仍存在疫苗相关麻痹型脊髓灰质炎(vaccine-associated paralytic poliomyelitis,VAPP)和疫苗衍生脊髓灰质炎病毒(vaccine-derived poliovirus,VDPV)病例的发生。为避免该风险,中国自2016年5月1日起停用三价OPV(trivalent oral poliomyelitis attenuated live vaccine,t OPV),改用二价脊髓灰质炎减毒活疫苗(bivalent oral poliomyelitis attenuated live vaccine,bOPV),并将IPV纳入国家免疫规划(national immunization program,NIP),即采用IPV-OPV-OPV-OPV序贯免疫程序进行接种,不仅能降低VAPP的发生,还能维持较高的肠道黏膜免疫力。本文就国内不同IPV-OPV序贯免疫程序的应用、免疫效果及安全性作一综述。
The implementation of oral live attenuated poliomyelitis vaccine(OPV)and inactivated poliomyelitis vaccine(IPV)plays an important role in the eradication of polio. However,the cases of vaccine-associated paralytic poliomyelitis(VAPP) and vaccine-derived poliovirus(VDPV) are still exist. In order to avoid the risk,Chinese government has stopped the application of trivalent oral poliomyelitis attenuated live vaccine(t OPV)and switched to that of bivalent oral poliomyelitis attenuated live vaccine(bOPV)since May 1,2016,and has included IPV into the National Immunization Program(NIP). Therefore,the IPV-OPV-OPV-OPV sequential immunization schedule has been adopted in China,which not only reduces the incidence of VAPP,but also maintains high intestinal mucosal immunity. In this paper,the application,immune effect and safety of various IPV-OPV sequential immunization schedules in China are reviewed.
The implementation of oral live attenuated poliomyelitis vaccine(OPV)and inactivated poliomyelitis vaccine(IPV)plays an important role in the eradication of polio. However,the cases of vaccine-associated paralytic poliomyelitis(VAPP) and vaccine-derived poliovirus(VDPV) are still exist. In order to avoid the risk,Chinese government has stopped the application of trivalent oral poliomyelitis attenuated live vaccine(t OPV)and switched to that of bivalent oral poliomyelitis attenuated live vaccine(bOPV)since May 1,2016,and has included IPV into the National Immunization Program(NIP). Therefore,the IPV-OPV-OPV-OPV sequential immunization schedule has been adopted in China,which not only reduces the incidence of VAPP,but also maintains high intestinal mucosal immunity. In this paper,the application,immune effect and safety of various IPV-OPV sequential immunization schedules in China are reviewed.
引文
[1] PENG X,HU X,SALAZAR M A. On reducing the risk of vaccine-associated paralytic poliomyelitis in the global transition from oral to inactivated poliovirus vaccine[J]. Lancet,2018,392(10147):610-612.
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[3] WEN N,SU Q R,AN Z J,et al. Considerations and suggestions for polio vaccination strategies in China[J]. Chin J Vaccin Immun,2018,24(3):349-353.(in Chinese)温宁,苏琪茹,安志杰,等.中国脊髓灰质炎疫苗免疫策略的思考及建议[J].中国疫苗和免疫,2018,24(3):349-353.
[4] JORBA J,DIOP O M,IBER J,et al. Update on vaccine-derived polioviruses-worldwide,January 2017-June 2018[J]. Morb Mortal Wkly Rep,2018,67(42):1189-1194.
[5] WANG H B,LUO H M,LI L,et al. Vaccine-derived poliovirus surveillance in China during 2001-2013:the potential challenge for maintaining polio free status[J]. BMC Infect Dis,2017,17(1):742.
[6] VIDOR E,JEAN D S. Inactivated poliovirus vaccines:an inevitable choice for eliminating poliomyelitis[J]. Chin J Prevent Med,2016,50(12):1021-1031.(in Chinese)VIDOR E,舒俭德.脊髓灰质炎病毒灭活疫苗:全球消灭脊髓灰质炎的必然选择[J].中华预防医学杂志,2016,50(12):1021-1031.
[7] LUO H M,YU W Z,WEN N,et al. Application of poliomyelitis vaccine and recommendation on switch of immunization strategies in China[J]. Chin J Vaccin Immun,2014,20(2):172-176.(in Chinese)罗会明,余文周,温宁,等.中国脊髓灰质炎疫苗使用历史回顾及免疫策略调整建议[J].中国疫苗和免疫,2014,20(2):172-176.
[8] PLATT L R,ESTIVARIZ C F,SUTTER R W. Vaccine-associated paralytic poliomyelitis:a review of the epidemiology and estimation of the global burden[J]. J Infect Dis,2014,210(Suppl 1):S380-S389.
[9] WHO. Polio vaccines:WHO position paper,March 2016-recommendations[J]. Vaccine, 2017,35(9):1197-1199.
[10] BONNET M C,DUTTA A. World wide experience with inactivated poliovirus vaccine[J]. Vaccine,2008,26(39):4978-4983.
[11] XIONG W Y,DONG Z. Review on the immunization strategy in polio post-eradication era and comparison of the safety of polio vaccination programs[J]. Chin J Pharmacovigilance,2017,14(2):90-94.(in Chinese)熊玮仪,董铎.消灭脊灰后期的免疫策略及脊灰疫苗不同免疫程序的安全性比较[J].中国药物警戒,2017,14(2):90-94.
[12] TAN Q,ZHU Q,ZHENG H,et al. Epidemiological serosurvey of poliovirus in Guangdong,China:a cross-sectional study[J].Hum Vaccin Immunother,2018,14(11):2644-2648.
[13] ZHAO D,MA R,ZHOU T,et al. Introduction of inactivated poliovirus vaccine and impact on vaccine-associated paralytic poliomyelitis-Beijing,China,2014-2016[J]. Morb Mortal Wkly Rep,2017,66(49):1357-1361.
[14] LIAO X Q,YANG T,LAN Y J. The influencing factors and coping strategies of vaccine-derived poliovirus[J]. Modern Prevent Med,2016,43(5):773-775.(in Chinese)廖香琼,杨婷,兰亚佳.脊髓灰质炎口服疫苗衍生病毒流行特征及应对策略[J].现代预防医学,2016,43(5):773-775.
[15] LI H Z,SUN M B,YANG J S. Research progress of sequential immunization schedule for poliomyelitis vaccine[J]. Chin J Vaccin Immun,2016,22(3):327-332.(in Chinese)李洪哲,孙明波,杨净思.脊髓灰质炎疫苗序贯免疫程序的研究与应用进展[J].中国疫苗和免疫,2016,22(3):327-332.
[16] HAMPTON L M,FARELL M,RAMIREZ-GONZALEZ A,et al. Cessation of trivalent oral poliovirus vaccine and introduction of inactivated poliovirus vaccine-worldwide, 2016[J].Morb Mortal Wkly Rep,2016,65(35):934-938.
[17] TANG G,YIN W,CAO Y,et al. Immunogenicity of sequential inactivated and oral poliovirus vaccines(OPV)versus inactivated poliovirus vaccine(IPV)alone in healthy infants:a systematic review and meta-analysis[J]. Hum Vaccin Immunother,2018,14(11):2636-2643.
[18] LU L,LI X M,LIU D L,et al. Study of immunogenicity after primary vaccination by different sequential program of inactivated poliovirus vaccine and oral poliovirus vaccine[J]. Chin J Prevent Med,2012,46(6):510-513.(in Chinese)卢莉,李晓梅,刘东磊,等.脊髓灰质炎灭活疫苗和减毒活疫苗不同序贯免疫程序的基础免疫效果研究[J].中华预防医学杂志,2012,46(6):510-513.
[19] LIN X L,YANG J,YE X L. Study of immunogenicity after primary vaccination by different sequential program of inactivated poliovirus vaccine and oral poliovirus vaccine[J]. Modern Prevent Med,2018,45(2):344-347.(in Chinese)林喜乐,杨洁,叶晓玲.不同序贯程序的脊髓灰质炎灭活疫苗和减毒活疫苗的免疫效果研究[J].现代预防医学,2018,45(2):344-347.
[20] LIU L,LI X,ZHANG H,et al. Immunogenicity and persistence from different 3-dose schedules of live and inactivated polio vaccines in Chinese infants[J]. Vaccine,2015,33(36):4653-4658.
[21] ZHANG L W,XU Y,XING H Y,et al. Evaluation of immune effects of primary and booster immunizations with inactivated and oral polio vaccines by various sequential programs in Changping District,Beijing City,China[J]. Chin J Biologicals,2014,27(10):1283-1287.(in Chinese)张丽文,许颖,邢海鹰,等.北京市昌平区脊髓灰质炎灭活疫苗与口服脊髓灰质炎减毒活疫苗不同序贯免疫程序的基础及加强免疫效果的评价[J].中国生物制品学杂志,2014,27(10):1283-1287.
[22] LI Q,HU Y,ZHANG B,et al. A meta-analysis on immunogenicity of one dose or two dose salk strain inactivated poliovirus vaccine among children under seven years[J]. J Prevent Med,2016,28(9):874-878,882.(in Chinese)李倩,胡昱,张兵,等. 7岁以下儿童接种1剂次或2剂次SalkIPV免疫效果的Meta分析[J].预防医学,2016,28(9):874-878,882.
[23] YING Z F,WANG J F,LI J,et al. Immuno-persistence of inactivated poliomyelitis vaccine in infants in China[J]. Chin J Biologicals,2012,25(9):1195-1197.(in Chinese)英志芳,王剑锋,李娟,等.脊髓灰质炎灭活疫苗在中国婴儿中的免疫持久性[J].中国生物制品学杂志,2012,25(9):1195-1197.
[24] LIU X C,HUANG T,CHE Y C,et al. Influence of maternal antibodies on effectiveness of different sequential immunization procedures of sIPV in infants[J]. Prog Microbiol Immunol,2018,46(3):1-7.(in Chinese)刘小畅,黄腾,车艳春,等.婴儿脊灰母传抗体对Sabin株脊髓灰质炎灭活疫苗不同序贯免疫接种程序效果的影响[J].微生物学免疫学进展,2018,46(3):1-7.
[25] LI Z,DING W,GUO Q,et al. Analysis of the dose-sparing effect of adjuvanted Sabin-inactivated poliovirus vaccine(sIPV)[J]. Hum Vaccin Immunother,2018,14(8):1987-1994.
[26] QIU J,YANG Y,HUANG L,et al. Immunogenicity and safety evaluation of bivalent types 1 and 3 oral poliovirus vaccine by comparing different poliomyelitis vaccination schedules in China:a randomized controlled non-inferiority clinical trial[J].Hum Vaccin Immunother, 2017,13(6):1-10.
[27] YE H,HUANG T,YING Z F,et al. Comparing the immunogenicity and safety of sequential inoculation of sIPV followed by b OPV(Ⅰ+Ⅲ)in different dosage forms[J]. Chin J Prevent Med,2018,52(1):43-49.(in Chinese)叶慧,黄腾,英志芳,等. Sabin株脊髓灰质炎灭活疫苗与不同剂型Ⅰ+Ⅲ型脊髓灰质炎减毒活疫苗序贯接种的免疫原性和安全性比较[J].中华预防医学杂志,2018,52(1):43-49.
[28] SUN L,CONG Y L,WANG J H,et al. Adverse events following immunization of bivalent oral poliovirus vaccines in Hebei province:analysis on surveillance data[J]. Chin J Public Health,2018,34(6):877-881.(in Chinese)孙丽,丛艳丽,王晶辉,等.二价脊灰疫苗疑似预防接种异常反应监测分析[J].中国公共卫生,2018,34(06):877-881.
[29] XIAO S C,LIU Y J,LI G Y,et al. Immuno-persistence of inactivated poliomyelitis vaccine in infants in China[J]. Chin J Biologicals,2018,34(14):1949-1951.(in Chinese)肖胜传,刘雅姬,黎国英,等.梅州市Sabin株脊髓灰质炎灭活疫苗替代减毒活疫苗序贯程序免疫效果[J].职业与健康,2018,34(14):1949-1951.
[30] IQBAL S,SHI J,SEIB K,et al. Preparation for global introduction of inactivated poliovirus vaccine:safety evidence from the US Vaccine Adverse Event Reporting System,2000-12[J].Lancet Infect Dis,2015,15(10):1175-1182.
[2] HU L N,YU W Z. Systematic review on application of poliomyelitis vaccine and immunization strategies[J]. Chin J Vaccin Immun,2014,20(1):73-78.(in Chinese)胡丽楠,余文周,罗会明.脊髓灰质炎疫苗应用现状及免疫策略进展[J].中国疫苗和免疫,2014,20(1):73-78.
[3] WEN N,SU Q R,AN Z J,et al. Considerations and suggestions for polio vaccination strategies in China[J]. Chin J Vaccin Immun,2018,24(3):349-353.(in Chinese)温宁,苏琪茹,安志杰,等.中国脊髓灰质炎疫苗免疫策略的思考及建议[J].中国疫苗和免疫,2018,24(3):349-353.
[4] JORBA J,DIOP O M,IBER J,et al. Update on vaccine-derived polioviruses-worldwide,January 2017-June 2018[J]. Morb Mortal Wkly Rep,2018,67(42):1189-1194.
[5] WANG H B,LUO H M,LI L,et al. Vaccine-derived poliovirus surveillance in China during 2001-2013:the potential challenge for maintaining polio free status[J]. BMC Infect Dis,2017,17(1):742.
[6] VIDOR E,JEAN D S. Inactivated poliovirus vaccines:an inevitable choice for eliminating poliomyelitis[J]. Chin J Prevent Med,2016,50(12):1021-1031.(in Chinese)VIDOR E,舒俭德.脊髓灰质炎病毒灭活疫苗:全球消灭脊髓灰质炎的必然选择[J].中华预防医学杂志,2016,50(12):1021-1031.
[7] LUO H M,YU W Z,WEN N,et al. Application of poliomyelitis vaccine and recommendation on switch of immunization strategies in China[J]. Chin J Vaccin Immun,2014,20(2):172-176.(in Chinese)罗会明,余文周,温宁,等.中国脊髓灰质炎疫苗使用历史回顾及免疫策略调整建议[J].中国疫苗和免疫,2014,20(2):172-176.
[8] PLATT L R,ESTIVARIZ C F,SUTTER R W. Vaccine-associated paralytic poliomyelitis:a review of the epidemiology and estimation of the global burden[J]. J Infect Dis,2014,210(Suppl 1):S380-S389.
[9] WHO. Polio vaccines:WHO position paper,March 2016-recommendations[J]. Vaccine, 2017,35(9):1197-1199.
[10] BONNET M C,DUTTA A. World wide experience with inactivated poliovirus vaccine[J]. Vaccine,2008,26(39):4978-4983.
[11] XIONG W Y,DONG Z. Review on the immunization strategy in polio post-eradication era and comparison of the safety of polio vaccination programs[J]. Chin J Pharmacovigilance,2017,14(2):90-94.(in Chinese)熊玮仪,董铎.消灭脊灰后期的免疫策略及脊灰疫苗不同免疫程序的安全性比较[J].中国药物警戒,2017,14(2):90-94.
[12] TAN Q,ZHU Q,ZHENG H,et al. Epidemiological serosurvey of poliovirus in Guangdong,China:a cross-sectional study[J].Hum Vaccin Immunother,2018,14(11):2644-2648.
[13] ZHAO D,MA R,ZHOU T,et al. Introduction of inactivated poliovirus vaccine and impact on vaccine-associated paralytic poliomyelitis-Beijing,China,2014-2016[J]. Morb Mortal Wkly Rep,2017,66(49):1357-1361.
[14] LIAO X Q,YANG T,LAN Y J. The influencing factors and coping strategies of vaccine-derived poliovirus[J]. Modern Prevent Med,2016,43(5):773-775.(in Chinese)廖香琼,杨婷,兰亚佳.脊髓灰质炎口服疫苗衍生病毒流行特征及应对策略[J].现代预防医学,2016,43(5):773-775.
[15] LI H Z,SUN M B,YANG J S. Research progress of sequential immunization schedule for poliomyelitis vaccine[J]. Chin J Vaccin Immun,2016,22(3):327-332.(in Chinese)李洪哲,孙明波,杨净思.脊髓灰质炎疫苗序贯免疫程序的研究与应用进展[J].中国疫苗和免疫,2016,22(3):327-332.
[16] HAMPTON L M,FARELL M,RAMIREZ-GONZALEZ A,et al. Cessation of trivalent oral poliovirus vaccine and introduction of inactivated poliovirus vaccine-worldwide, 2016[J].Morb Mortal Wkly Rep,2016,65(35):934-938.
[17] TANG G,YIN W,CAO Y,et al. Immunogenicity of sequential inactivated and oral poliovirus vaccines(OPV)versus inactivated poliovirus vaccine(IPV)alone in healthy infants:a systematic review and meta-analysis[J]. Hum Vaccin Immunother,2018,14(11):2636-2643.
[18] LU L,LI X M,LIU D L,et al. Study of immunogenicity after primary vaccination by different sequential program of inactivated poliovirus vaccine and oral poliovirus vaccine[J]. Chin J Prevent Med,2012,46(6):510-513.(in Chinese)卢莉,李晓梅,刘东磊,等.脊髓灰质炎灭活疫苗和减毒活疫苗不同序贯免疫程序的基础免疫效果研究[J].中华预防医学杂志,2012,46(6):510-513.
[19] LIN X L,YANG J,YE X L. Study of immunogenicity after primary vaccination by different sequential program of inactivated poliovirus vaccine and oral poliovirus vaccine[J]. Modern Prevent Med,2018,45(2):344-347.(in Chinese)林喜乐,杨洁,叶晓玲.不同序贯程序的脊髓灰质炎灭活疫苗和减毒活疫苗的免疫效果研究[J].现代预防医学,2018,45(2):344-347.
[20] LIU L,LI X,ZHANG H,et al. Immunogenicity and persistence from different 3-dose schedules of live and inactivated polio vaccines in Chinese infants[J]. Vaccine,2015,33(36):4653-4658.
[21] ZHANG L W,XU Y,XING H Y,et al. Evaluation of immune effects of primary and booster immunizations with inactivated and oral polio vaccines by various sequential programs in Changping District,Beijing City,China[J]. Chin J Biologicals,2014,27(10):1283-1287.(in Chinese)张丽文,许颖,邢海鹰,等.北京市昌平区脊髓灰质炎灭活疫苗与口服脊髓灰质炎减毒活疫苗不同序贯免疫程序的基础及加强免疫效果的评价[J].中国生物制品学杂志,2014,27(10):1283-1287.
[22] LI Q,HU Y,ZHANG B,et al. A meta-analysis on immunogenicity of one dose or two dose salk strain inactivated poliovirus vaccine among children under seven years[J]. J Prevent Med,2016,28(9):874-878,882.(in Chinese)李倩,胡昱,张兵,等. 7岁以下儿童接种1剂次或2剂次SalkIPV免疫效果的Meta分析[J].预防医学,2016,28(9):874-878,882.
[23] YING Z F,WANG J F,LI J,et al. Immuno-persistence of inactivated poliomyelitis vaccine in infants in China[J]. Chin J Biologicals,2012,25(9):1195-1197.(in Chinese)英志芳,王剑锋,李娟,等.脊髓灰质炎灭活疫苗在中国婴儿中的免疫持久性[J].中国生物制品学杂志,2012,25(9):1195-1197.
[24] LIU X C,HUANG T,CHE Y C,et al. Influence of maternal antibodies on effectiveness of different sequential immunization procedures of sIPV in infants[J]. Prog Microbiol Immunol,2018,46(3):1-7.(in Chinese)刘小畅,黄腾,车艳春,等.婴儿脊灰母传抗体对Sabin株脊髓灰质炎灭活疫苗不同序贯免疫接种程序效果的影响[J].微生物学免疫学进展,2018,46(3):1-7.
[25] LI Z,DING W,GUO Q,et al. Analysis of the dose-sparing effect of adjuvanted Sabin-inactivated poliovirus vaccine(sIPV)[J]. Hum Vaccin Immunother,2018,14(8):1987-1994.
[26] QIU J,YANG Y,HUANG L,et al. Immunogenicity and safety evaluation of bivalent types 1 and 3 oral poliovirus vaccine by comparing different poliomyelitis vaccination schedules in China:a randomized controlled non-inferiority clinical trial[J].Hum Vaccin Immunother, 2017,13(6):1-10.
[27] YE H,HUANG T,YING Z F,et al. Comparing the immunogenicity and safety of sequential inoculation of sIPV followed by b OPV(Ⅰ+Ⅲ)in different dosage forms[J]. Chin J Prevent Med,2018,52(1):43-49.(in Chinese)叶慧,黄腾,英志芳,等. Sabin株脊髓灰质炎灭活疫苗与不同剂型Ⅰ+Ⅲ型脊髓灰质炎减毒活疫苗序贯接种的免疫原性和安全性比较[J].中华预防医学杂志,2018,52(1):43-49.
[28] SUN L,CONG Y L,WANG J H,et al. Adverse events following immunization of bivalent oral poliovirus vaccines in Hebei province:analysis on surveillance data[J]. Chin J Public Health,2018,34(6):877-881.(in Chinese)孙丽,丛艳丽,王晶辉,等.二价脊灰疫苗疑似预防接种异常反应监测分析[J].中国公共卫生,2018,34(06):877-881.
[29] XIAO S C,LIU Y J,LI G Y,et al. Immuno-persistence of inactivated poliomyelitis vaccine in infants in China[J]. Chin J Biologicals,2018,34(14):1949-1951.(in Chinese)肖胜传,刘雅姬,黎国英,等.梅州市Sabin株脊髓灰质炎灭活疫苗替代减毒活疫苗序贯程序免疫效果[J].职业与健康,2018,34(14):1949-1951.
[30] IQBAL S,SHI J,SEIB K,et al. Preparation for global introduction of inactivated poliovirus vaccine:safety evidence from the US Vaccine Adverse Event Reporting System,2000-12[J].Lancet Infect Dis,2015,15(10):1175-1182.