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

Study of immunogenicity after primary vaccination by different sequential program of inactivated poliovirus vaccine and oral poliovirus vaccine

目的评价脊髓灰质炎灭活疫苗（inactivated polio vaccine，IPV）与脊髓灰质炎减毒活疫苗（oral polio vaccine，OPV）不同序贯免疫程序的基础免疫效果。方法选择在北京居住的≥2月龄（60～89d）婴儿，分为1剂IPV和2剂OPV序贯（I-O—O，122名）、2剂IPV和1剂OPV序贯（I—I-O，103名）、IPV全程（I—I—I，114名）、OPV全程（O—O—O，106名）共4组，分别在2、3、4月龄时接种。检测其血清中脊髓灰质炎中和抗体，以及接种1剂和2剂IPV后的抗体滴度，计算各组保护率。结果完成基础免疫后，O—O—O组I、Ⅱ、Ⅲ型抗体几何平均滴度（GMT）分别为788．32、738．42、631．17，I-I-I组分别为212．02、262．30、537．52，I-O-O组分别为940．35、929．72、940．35，I-I-O组分别为901．09、1102．68、1110．12，差异均有统计学意义（F值分别为47．71、53．84、9．81，P值均〈0．01）；各组3个型别的抗体保护率为98．1％（104／106）～100．0％，差异无统计学意义（P〉0．05）。接种第1剂IPV后，I-O—O组I、Ⅱ、Ⅲ型抗体GMT分别为18．88、37．77、24．64，保护率为82．6％（122／138）。96．4％（133／138）；接种第2剂IPV后，I—I-O组I、Ⅱ、Ⅲ型抗体GMT分别为177．03、168．25、321．86，保护率为99．1％（108／109）～100．0％（109／109）。结论IPV与OPV序贯接种后，脊髓灰质炎中和抗体GMT比单独接种3剂IPV或3剂OPV高；序贯程序中，接种2剂IPV后抗体保护率达到较高水平，有利于减少疫苗相关麻痹病例（VAPP）。为维持高水平免疫屏障并避免VAPP发生，可采用IPV与OPV序贯程序，并以2剂IPV的序贯程序为首选。

Objective To evaluate immunogenicity after primary vaccination by different sequential program of inactivated poliovirus vaccine （ IPV ） and oral poliovirus vaccine （ OPV ）. Methods Children of 2 months old（60 -89 days） selected in Beijing were assigned to 4 groups, 1 dose IPV plus 2 doses OPV （I-O-O,122 children）, 2 doses IPV plus 1 dose OPV （ I-I-O, 103 children）, 3 doses IPV （ I-I-I, 114 children）, and 3 doses OPV （O-O-O, 106 children）, and were vaccinated at the age of 2,3,4 months. Polio neutralizing antibody titers against poliovirus types 1,2, and 3 were tested and protective rates were calculated before the 1st dose, after the last dose, and after the 1 st and 2nd dose of IPV. Results After the primary immunization, geometric mean titers （ GMT ） of polio neutralizing antibody titers against poliovirus types 1,2,and 3 were 788.32,738.42 and 631.17 in O-O-O group, 212.02,262.30 and 537. 52 in I-I-I group, 940. 35,929. 72 and 940. 35 in I-O-O group and 901.09,1102. 68 and 1110. 12 in I-I-O group （ F values were 47. 71,53.84, and 9. 81 respectively, all P values 〈 0. 01 ）. The protective rate of three types among each group was 98. 1% （104/106） - 100. 0% and the difference was not statistically significant （P 〉0.05）. After the 1st dose of IPV, the GMT were 18.88,37.77,24. 64 and the protective rate was 82. 6% （122/138） - 96.4% （133/138） ; after the 2nd dose of IPV, GMT were 177. 03,168. 25,321.86 and the protective rate was 99. 1% （ 108/109 ） - 100.0% （ 109/109 ） in antibody types 1, 2 and 3, respectively. Conclusion GMT of polio neutralizing antibody titers against poliovirus is higher after vaccination by sequential program of IPV and OPV than that by IPV or OPV 3-doses program. High level of protective rate after 2 doses of IPV in I-I-O group may lead to better protection from vaccine associated paralytic poliomyelitis（VAPP）. Sequential program of IPV and OPV can be used to maintain high level of herd immunity and to prevent VAPP, and the I-I-O sequential program should be the first choice.