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
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摘要
目的评价我国国产脊髓灰质炎灭活疫苗(Sabin株)和口服脊髓灰质炎减毒活疫苗序贯接种基础免疫的效果。方法采用同期非随机对照实验研究方法,于2015年9~12月期间,在宁夏回族自治区吴忠市同心县选择满2月龄健康儿童180人,按照国家规定的免疫程序,分别在2、3、4月龄各接种1剂次脊髓灰质炎疫苗。将上述儿童分为两组:一组采用t OPV+t OPV+t OPV的基础免疫程序(简称O-O-O组),另一组采用国产IPV(Sabin株)+t OPV+t OPV(简称I-O-O组)序贯接种的基础免疫程序。分别采集同一受种者免疫前和完成3剂次脊髓灰质炎疫苗基础免疫后30 d的血清标本,采用微量中和试验测定血清中3个脊髓灰质炎型别(Ⅰ、Ⅱ、Ⅲ型)的抗体滴度,计算GMT及抗体保护率。结果 3剂次脊髓灰质炎疫苗基础免疫程序接种完成后,I-O-O组脊髓灰质炎Ⅱ、Ⅲ型抗体滴度均高于O-O-O组;两组均获得较好的针对3种型别脊髓灰质炎病毒的抗体保护率,差异无统计学意义(P>0.05)。结论国产IPV(Sabin株)和t OPV序贯接种的免疫程序能够提供与全程接种t OPV相似甚至更高的针对脊髓灰质炎病毒的免疫保护能力。
Objective To evaluate the effect of sequential immunization with domestic inactivated poliovirus vaccine and oral live attenuated poliomyelitis vaccine. Methods A non-randomized controlled experimental study was carried out.During the period from September to December 2015,180 healthy children at age of 2 months in Tongxin County,Ningxia Hui Autonomous Region,China were selected,and immunized with poliovirus vaccine at ages of 2,3 and 4 months according to the national immunization schedule. The children were divided into two groups,one for a immunization schedule of t OPV + t OPV + t OPV(O-O-O) while another one for IPV(Sabin) + t OPV + t OPV(I-O-O). The serum samples were collected before the first dose and 30 d after the third dose,and determined for antibody titers against poliovirus of types Ⅰ,Ⅱ and Ⅲ,based on which the GMT and protection rate were calculated. Results After 3 doses of vaccines were given,the antibody titers against poliovirus of typesⅡand Ⅲ in I-O-O group were higher than those in O-O-O group. However,high protective rates against the three types of poliovirus were observed in the two groups,which showed no significant difference(P > 0. 05). Conclusion Compared with full course of immunization with t OPV,the sequential immunization with domestic IPV(Sabin)and t OPV provided similar or even higher immune protection against poliovirus.
Objective To evaluate the effect of sequential immunization with domestic inactivated poliovirus vaccine and oral live attenuated poliomyelitis vaccine. Methods A non-randomized controlled experimental study was carried out.During the period from September to December 2015,180 healthy children at age of 2 months in Tongxin County,Ningxia Hui Autonomous Region,China were selected,and immunized with poliovirus vaccine at ages of 2,3 and 4 months according to the national immunization schedule. The children were divided into two groups,one for a immunization schedule of t OPV + t OPV + t OPV(O-O-O) while another one for IPV(Sabin) + t OPV + t OPV(I-O-O). The serum samples were collected before the first dose and 30 d after the third dose,and determined for antibody titers against poliovirus of types Ⅰ,Ⅱ and Ⅲ,based on which the GMT and protection rate were calculated. Results After 3 doses of vaccines were given,the antibody titers against poliovirus of typesⅡand Ⅲ in I-O-O group were higher than those in O-O-O group. However,high protective rates against the three types of poliovirus were observed in the two groups,which showed no significant difference(P > 0. 05). Conclusion Compared with full course of immunization with t OPV,the sequential immunization with domestic IPV(Sabin)and t OPV provided similar or even higher immune protection against poliovirus.
引文
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[2]HU L N,YU W Z,LUO H M.Systematic review on application of poliomyelitis vaccine and immunization strategies[J].Chin J Vac 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.
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[6]LIU H B,LIN J P,WU Y H,et al.Serological responses following primary immunization with poliomyelitis vaccine by various schedules[J].Chin J Biologicals,2013,26(11):1641-1643.(in Chinese)刘洪波,林嘉鹏,吴衍恒,等.不同脊髓灰质炎疫苗免疫程序基础免疫后的血清学反应[J].中国生物制品学杂志,2013,26(11):1641-1643.
[7]MODLIN J F,HALSEY N A,THOMS M L,et al.Humoral and mucosal immunity in infants induced by three sequential inactivated poliovirus vaccine-live attenuated oral poliovirus vaccine immunization schedules[J].Infect Dis,1997,175(Suppl1):S228-S234.
[8]BONNET M C,DUTTA A.World wide experience with inactivated poliovirus vaccine[J].Vaccine,2008,26(39):4978-4983.
[9]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 randomized,controlled,open-label,phase 4,non-inferiority study[J].Lancet Infect Dis,2015,15(11):1273-1282.
[10]MCBEAN A M,THOMS M L,ALBRECHT P,et al.Serologic response to oral polio vaccine and enhanced-potency inactivated polio vaccines[J].Am J Epidem,1988,128(3):615-628.
[2]HU L N,YU W Z,LUO H M.Systematic review on application of poliomyelitis vaccine and immunization strategies[J].Chin J Vac 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]WATTIGNEY W A,MOOTREY G T,BRAUN M M,et al.Surveillance for poliovirus vaccine adverse events,1991 to 1998:impact of a sequential vaccination schedule of inactivated poliovirus vaccine followed by oral poliovirus vaccine[J].Pediatrics,2001,107(5):E83.
[4]LU L,LI X M,LIU D L,et al.Study of immunogenicity after primary vaccination by sequential program of inactivated poliovirus vaccine and oral poliovirus vaccine[J].Chin J Prev 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.
[5]WHO.Polio Vaccines:WHO Position Paper,January 2014[J].WER,2014,89(9):73-92.WHO.世界卫生组织关于脊髓灰质炎疫苗的立场文件(2014年2月)[J].中国疫苗和免疫,2014,20(4):376-380.
[6]LIU H B,LIN J P,WU Y H,et al.Serological responses following primary immunization with poliomyelitis vaccine by various schedules[J].Chin J Biologicals,2013,26(11):1641-1643.(in Chinese)刘洪波,林嘉鹏,吴衍恒,等.不同脊髓灰质炎疫苗免疫程序基础免疫后的血清学反应[J].中国生物制品学杂志,2013,26(11):1641-1643.
[7]MODLIN J F,HALSEY N A,THOMS M L,et al.Humoral and mucosal immunity in infants induced by three sequential inactivated poliovirus vaccine-live attenuated oral poliovirus vaccine immunization schedules[J].Infect Dis,1997,175(Suppl1):S228-S234.
[8]BONNET M C,DUTTA A.World wide experience with inactivated poliovirus vaccine[J].Vaccine,2008,26(39):4978-4983.
[9]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 randomized,controlled,open-label,phase 4,non-inferiority study[J].Lancet Infect Dis,2015,15(11):1273-1282.
[10]MCBEAN A M,THOMS M L,ALBRECHT P,et al.Serologic response to oral polio vaccine and enhanced-potency inactivated polio vaccines[J].Am J Epidem,1988,128(3):615-628.