脊髓灰质炎免疫策略调整进程中不同免疫程序接种效果的比较
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摘要
目的比较脊髓灰质炎(简称脊灰)免疫策略调整过程中不同免疫程序的接种效果。方法在广西壮族自治区开展三价脊灰减毒活疫苗(trivalent oral poliovirus vaccine,tOPV)、Sabin株脊灰灭活疫苗(inactivated poliovirus vaccine,IPV)和脊灰减毒活疫苗(oral poliovirus vaccine,OPV)不同序贯免疫接种,分8个免疫程序组:3剂tOPV糖丸组及液体组、2sIPV+1tOPV糖丸组及液体组、1sIPV+2bOPV糖丸组及液体组、2sIPV+1bOPV糖丸组及液体组;比较各程序组全程基础免疫后28 d血清中脊灰中和抗体阳转率及几何平均滴度(geometric mean titer,GMT)。结果全程基础免疫后sIPV+2bOPV组及2sIPV+bOPV组两种剂型Ⅰ、Ⅲ抗体GMT均高于3剂tOPV组,Ⅱ型抗体阳转率及GMT均低于3剂tOPV组(P <0. 001);2sIPV+bOPV组两种剂型免疫后Ⅰ、Ⅲ型抗体阳转率及GMT均高于2sIPV+tOPV组;IPV/bOPV序贯免疫中,接种2剂IPV后的Ⅰ、Ⅱ、Ⅲ型抗体阳转率及GMT均高于接种1剂IPV,且Ⅱ型抗体阳转率和Ⅱ、Ⅲ抗体GMT差异均有统计学意义(P <0. 001)。结论脊灰免疫策略转换前后不同的免疫程序疫苗接种效果存在差异,建议在IPV供应充足的情况下逐步增加IPV剂次,减少b OPV剂次,实现最终全程接种IPV。
Objective To compare the vaccination effects of various immunization schedules during adjustment of strategy for poliomyelitis immunization. Methods A clinical trial of trivalent oral poliovirus vaccine(tOPV),inactivated poliomyelitis vaccine prepared with Sabin strain(sIPV)and oral poliovirus vaccine(OPV)by different sequential immunization schedules was performed in 1 800 infants in Guangxi Zhuang Autonomous Region,China. The infants were divided into eight groups according to the immunization schedule: 3 doses of tOPV drug candy(DC)group,2 sIPV + 1 tOPV DC group,1 sIPV + 2 bOPV(bivalent OPV)DC group,2 sIPV + 1 bOPV DC group,3 doses of tOPV liquid group,2 sIPV + 1 tOPV liquid group,1 sIPV + 2 b OPV liquid group and 2 sIPV + 1 bOPV liquid group. The seroconversion rates and geometric mean titer(GMT)of poliomyelitis neutralizing antibody 28 days after the full course basic immunization in various groups were compared. Results The GMTs of types I and Ⅲantibodies in sIPV + 2 bOPV and 2 sIPV + bOPV groups were higher,while the positive conversion rate of type Ⅱ antibody were lower,than those in 3 dose of t OPV group(P < 0. 001). However,both the seroconversion rate and GMT of types Ⅰ and Ⅲ antibodies in 2 sIPV + bOPV groups were higher than those in 2 sIPV +t OPV groups. In the sequential immunization with IPV/b OPV,the seroconversion rates and GMTs of types Ⅰ,Ⅱ and Ⅲantibodies after immunization with two doses of IPV were higher than those after immunization with one dose,while there were significant differences in seroconversion rates of type Ⅱ antibody and the GMTs of types Ⅱ and Ⅲ antibodies(P < 0. 001).Conclusion There are differences in the effects of various immunization schedules during transformation of poliomyelitis immunization strategy. It is suggested to increase the doses of IPV and decrease the doses of bOPV gradually under the condition of adequate supply of IPV so as to realize the full course immunization strategy of IPV.
Objective To compare the vaccination effects of various immunization schedules during adjustment of strategy for poliomyelitis immunization. Methods A clinical trial of trivalent oral poliovirus vaccine(tOPV),inactivated poliomyelitis vaccine prepared with Sabin strain(sIPV)and oral poliovirus vaccine(OPV)by different sequential immunization schedules was performed in 1 800 infants in Guangxi Zhuang Autonomous Region,China. The infants were divided into eight groups according to the immunization schedule: 3 doses of tOPV drug candy(DC)group,2 sIPV + 1 tOPV DC group,1 sIPV + 2 bOPV(bivalent OPV)DC group,2 sIPV + 1 bOPV DC group,3 doses of tOPV liquid group,2 sIPV + 1 tOPV liquid group,1 sIPV + 2 b OPV liquid group and 2 sIPV + 1 bOPV liquid group. The seroconversion rates and geometric mean titer(GMT)of poliomyelitis neutralizing antibody 28 days after the full course basic immunization in various groups were compared. Results The GMTs of types I and Ⅲantibodies in sIPV + 2 bOPV and 2 sIPV + bOPV groups were higher,while the positive conversion rate of type Ⅱ antibody were lower,than those in 3 dose of t OPV group(P < 0. 001). However,both the seroconversion rate and GMT of types Ⅰ and Ⅲ antibodies in 2 sIPV + bOPV groups were higher than those in 2 sIPV +t OPV groups. In the sequential immunization with IPV/b OPV,the seroconversion rates and GMTs of types Ⅰ,Ⅱ and Ⅲantibodies after immunization with two doses of IPV were higher than those after immunization with one dose,while there were significant differences in seroconversion rates of type Ⅱ antibody and the GMTs of types Ⅱ and Ⅲ antibodies(P < 0. 001).Conclusion There are differences in the effects of various immunization schedules during transformation of poliomyelitis immunization strategy. It is suggested to increase the doses of IPV and decrease the doses of bOPV gradually under the condition of adequate supply of IPV so as to realize the full course immunization strategy of IPV.
引文
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[2] LIU X C,HUANG T,CHE Y C,et al. Influence of maternal antibodies on effectiveness of different sequential immunization procedures of s IPV 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.
[3] Strategic Advisory Group of Experts(SAGE)on Immunization23-25 October 2018[EB/OL].(2019-01-21). https://www.who.int/immunization/sage/meetings/2018/october/YB_SAGE_October_2018_final.pdf?ua=1.
[4] The Global Polio Eradication Initiative. List of wild poliovirus by country and year[EB/OL].(2018-12-13). http://polioeradication.org/polio-today/polio-now/wild-poliovirus-list/
[5] FERREYRAREYES L,CRUZHERVERT L P,TROY S B,et al.Assessing the individual risk of fecal poliovirus shedding among vaccinated and non-vaccinated subjects following national health weeks in Mexico[J]. Plos One,2017,12(10):1-16.
[6] XING L L,CAO L S. Poliomyelitis immunization status and progress[J]. Chin J Vaccin Immun,2018,24(2):243-248.(in Chinese)邢力莉,曹玲生.脊髓灰质炎疫苗接种现状与进展[J].中国疫苗和免疫,2018,24(2):243-248.
[7] GRASSLY N C,JAFARI H,BAHL S,et al. Waning intestinal immunity after vaccination with oral poliovirus vaccines in India[J]. J Infect Dis,2012,205(10):1554-1561.
[8] SHI X J,LIU L,ZHOU L W,et al. Evaluation on effect of sequential immunization with inactivated poliovirus vaccine and oral live attenuated poliomyelitis vaccine[J]. Chin J Biologicals,2018,31(5):519-522.(in Chinese)石晓娟,刘兰,周莉薇,等.国产脊髓灰质炎灭活疫苗和口服减毒活疫苗序贯接种基础免疫效果评价[J].中国生物制品学杂志,2018,31(5):519-522.
[9] ZHANG L W,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.
[10] LI J,ZHANG Z J Z,ZHAO D,et al. Immunogenicity of primary poliovirus vaccination schedules before and after introduction of bivalent oral poliovirus vaccine in Beijing[J]. Chin J Vaccin Immun,2017(6):613-616.(in Chinese)李娟,张朱佳子,赵丹,等.北京市二价脊髓灰质炎减毒活疫苗引入前后不同基础免疫程序效果和疫苗效价分析[J].中国疫苗和免疫,2017(6):613-616.
[11] TANG G,YIN W,CAO Y D,et al. Immunogenicity of sequential inactivated(IPV)and oral(OPV)poliovirus vaccines versus inactivated polio vaccine alone in healthy infants:a systematic review and meta-analysis[J]. Hum Vaccin&Immunother,2018(11):1-23.
[12] O'RYAN M,BANDYOPADHYAY A S,VILLENA R,et al.Inactivated poliovirus vaccine given alone or in a sequential schedule with bivalent oral poliovirus vaccine in Chilean infants:a randomised,controlled,open-label,phase 4,non-inferiority study[J]. Lancet Infect Dis,2015,15(11):1273-1282.
[13] ASTURIAS E J,BANDYOPADHYAY A S,SELF S,et al.Humoral and intestinal immunity induced by new schedules of bivalent oral poliovirus vaccine and one or two doses of inactivated poliovirus vaccine in Latin American infants:an open-label randomised controlled trial[J]. Lancet,2016,158-169.
[14] LI H Z,SUN M B,YANG J S. Research progress of sequential immunization schedule for poliomyelitis vaccine[J]. Chin J Vaccin Immun,2016(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(3):327-332.
[15] 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(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(2):344-347.
[16] DESAI S,DIENER T,BJ K T,et al. An unusual case of vaccine-associated paralytic poliomyelitis[J]. Can J Infect Dis Med Microbiol,2014,25(4):227-228.
[2] LIU X C,HUANG T,CHE Y C,et al. Influence of maternal antibodies on effectiveness of different sequential immunization procedures of s IPV 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.
[3] Strategic Advisory Group of Experts(SAGE)on Immunization23-25 October 2018[EB/OL].(2019-01-21). https://www.who.int/immunization/sage/meetings/2018/october/YB_SAGE_October_2018_final.pdf?ua=1.
[4] The Global Polio Eradication Initiative. List of wild poliovirus by country and year[EB/OL].(2018-12-13). http://polioeradication.org/polio-today/polio-now/wild-poliovirus-list/
[5] FERREYRAREYES L,CRUZHERVERT L P,TROY S B,et al.Assessing the individual risk of fecal poliovirus shedding among vaccinated and non-vaccinated subjects following national health weeks in Mexico[J]. Plos One,2017,12(10):1-16.
[6] XING L L,CAO L S. Poliomyelitis immunization status and progress[J]. Chin J Vaccin Immun,2018,24(2):243-248.(in Chinese)邢力莉,曹玲生.脊髓灰质炎疫苗接种现状与进展[J].中国疫苗和免疫,2018,24(2):243-248.
[7] GRASSLY N C,JAFARI H,BAHL S,et al. Waning intestinal immunity after vaccination with oral poliovirus vaccines in India[J]. J Infect Dis,2012,205(10):1554-1561.
[8] SHI X J,LIU L,ZHOU L W,et al. Evaluation on effect of sequential immunization with inactivated poliovirus vaccine and oral live attenuated poliomyelitis vaccine[J]. Chin J Biologicals,2018,31(5):519-522.(in Chinese)石晓娟,刘兰,周莉薇,等.国产脊髓灰质炎灭活疫苗和口服减毒活疫苗序贯接种基础免疫效果评价[J].中国生物制品学杂志,2018,31(5):519-522.
[9] ZHANG L W,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.
[10] LI J,ZHANG Z J Z,ZHAO D,et al. Immunogenicity of primary poliovirus vaccination schedules before and after introduction of bivalent oral poliovirus vaccine in Beijing[J]. Chin J Vaccin Immun,2017(6):613-616.(in Chinese)李娟,张朱佳子,赵丹,等.北京市二价脊髓灰质炎减毒活疫苗引入前后不同基础免疫程序效果和疫苗效价分析[J].中国疫苗和免疫,2017(6):613-616.
[11] TANG G,YIN W,CAO Y D,et al. Immunogenicity of sequential inactivated(IPV)and oral(OPV)poliovirus vaccines versus inactivated polio vaccine alone in healthy infants:a systematic review and meta-analysis[J]. Hum Vaccin&Immunother,2018(11):1-23.
[12] O'RYAN M,BANDYOPADHYAY A S,VILLENA R,et al.Inactivated poliovirus vaccine given alone or in a sequential schedule with bivalent oral poliovirus vaccine in Chilean infants:a randomised,controlled,open-label,phase 4,non-inferiority study[J]. Lancet Infect Dis,2015,15(11):1273-1282.
[13] ASTURIAS E J,BANDYOPADHYAY A S,SELF S,et al.Humoral and intestinal immunity induced by new schedules of bivalent oral poliovirus vaccine and one or two doses of inactivated poliovirus vaccine in Latin American infants:an open-label randomised controlled trial[J]. Lancet,2016,158-169.
[14] LI H Z,SUN M B,YANG J S. Research progress of sequential immunization schedule for poliomyelitis vaccine[J]. Chin J Vaccin Immun,2016(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(3):327-332.
[15] 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(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(2):344-347.
[16] DESAI S,DIENER T,BJ K T,et al. An unusual case of vaccine-associated paralytic poliomyelitis[J]. Can J Infect Dis Med Microbiol,2014,25(4):227-228.