脊髓灰质炎灭活疫苗与二价脊髓灰质炎减毒活疫苗两种序贯基础免疫程序的免疫原性比较

Immunogenicity of two sequential primary immunization schedules with inactivated poliovirus vaccine and bivalent oral poliomyelitis attenuated live vaccine

目的比较脊髓灰质炎(脊灰)灭活疫苗(Inactivated poliovirus vaccine,IPV)与I+III型二价脊灰减毒活疫苗(Bivalent oral poliovirus vaccine,bOPV)两种序贯基础免疫程序的免疫原性。方法在河北省肥乡区招募健康婴儿,随机分成两组,按2-3-4月龄基础免疫程序分别接种IPV-bOPV-bOPV和IPV-IPV-bOPV,检测基础免疫前和免疫后28-42d血清脊灰病毒Ⅰ、Ⅱ、Ⅲ型中和抗体,分析中和抗体阳性率、阳转率和几何平均滴度(Geometric mean titer,GMT)。结果IPV-bOPV-bOPV、IPV-IPV-bOPV程序组分别招募受试者69名、68名,两组婴儿基础免疫后脊灰病毒中和抗体阳性率分别为Ⅰ型100%、100%,Ⅱ型98.55%、100%,Ⅲ型100%、100%;阳转率分别为Ⅰ型100%、100%,Ⅱ型97.06%、100%(Fisher确切概率法,P>0.05),Ⅲ型100%、100%;GMT增长倍数分别为Ⅰ型758倍、810倍(Z=-0.62,P=0.535),Ⅱ型5倍、26倍(Z=-5.15,P<0.001),Ⅲ型379倍、634倍(Z=-3.34,P=0.001)。结论两种IPV与bOPV序贯基础免疫程序均具有良好的免疫原性;IPV-IPV-bOPV程序对Ⅱ、Ⅲ型脊灰病毒的免疫原性优于IPV-bOPV-bOPV程序。

Objective To compare the immunogenicity of two sequential primary immunization schedules with inactivated poliovirus vaccine(IPV)and bivalent oral poliomyelitis attenuated live vaccine(bOPV).Methods We recruited healthy infants in Feixiang district of Hebei province and randomly allocated them into two groups to receive either IPV-bOPV-bOPV or IPV-IPV-bOPV in 2-3-4-month-old immunization schedules.We tested for neutralization antibodies of type I,II,and III poliovirus in sera obtained before and 28-42 days after vaccination to analyze positivity rates,seroconversion rates,and geometric mean titers(GMTs).Results We enrolled 69 and 68 infants into the IPV-bOPV-bOPV group and the IPV-IPV-bOPV group,respectively.By respective study group,neutralizing antibody positivity rates after vaccination were 100%and 100%for typeⅠpoliovirus,98.55%and 100%for typeⅡpoliovirus,and 100%and 100%for typeⅢpoliovirus;seroconversion rates after vaccination were 100%and 100%for typeⅠ,97.06%and 100%(Fisher’s exact test,P>0.05)for typeⅡ,and 100%and 100%for typeⅢ;GMTs after vaccination increased by 758-and 810-fold(Z=-0.62,P=0.535)for type I,5-and 26-fold(Z=-5.15,P<0.001)for type II,and 379-and 634-fold(Z=-3.34,P=0.001)for type III.Conclusion Both sequential primary immunization schedules were shown to have good immunogenicity;the IPV-IPV-bOPV schedule was more immunogenic than the IPVbOPV-bOPV schedule for type II and type III poliovirus.