目的  对采用不同配制方式制备的，含不同剂量Sabin株脊髓灰质炎（脊灰）灭活疫苗（Sabin strain inactivated poliovirus vaccine，sIPV）的DTaP-sIPV联合疫苗中sIPV的免疫原性进行研究。 方法  按照2种不同方式配制含高、低剂量sIPV的DTaP-sIPV联合疫苗。将70只大鼠按简单随机法分成7组，分别为F1H（DTaP-sIPV高剂量组，配制方式1）、F2H（DTaP-sIPV高剂量组，配制方式2）、sIPV-H（sIPV高剂量组）、F1L（DTaP-sIPV低剂量组，配制方式1）、F2L（DTaP-sIPV低剂量组，配制方式2）、sIPV-L（sIPV低剂量组）、赛诺菲巴斯德五联疫苗潘太欣组。每组10只大鼠，间隔3周双侧后腿肌内注射，0.5 ml/只，共免疫3针。于第0、3、6、9、13、17、21、25周眼眶采血、分离血清，采用微量细胞病变效应抑制法分别测定血清中抗Ⅰ、Ⅱ、Ⅲ型脊灰病毒中和抗体滴度，并进行多样本均数方差分析。结果  每针免疫后，各组抗各型中和抗体滴度均持续上升，第9周均达到最高水平，第13周开始显著下降，至第25周仍维持在一定水平。3针免疫完成后3周，F2H组的抗Ⅰ型脊灰病毒中和抗体几何平均滴度显著高于潘太欣组（F=0.988，P=0.027）；抗Ⅱ型中和抗体，F2H组显著高于F1H组，sIPV-H组显著高于F1H和潘太欣组（F=2.391，P值均<0.05）；抗Ⅲ型中和抗体，各组间差异均无统计学意义。3针基础免疫后各时间点F2H组抗各型中和抗体滴度均为最高，但除第9周其抗Ⅱ型中和抗体显著高于F1H组外，其他差异均无统计学意义。结论  DTaP-sIPV联合疫苗免疫大鼠后可以诱导产生抗各型中和抗体，且其滴度和持续时间均优于或等同于潘太欣组。DTaP-sIPV诱导的中和抗体滴度不低于相应剂量的sIPV。虽然配制方式2可能更佳，但2种配制方式间sIPV的免疫原性差异无统计学意义。

Objective  To evaluate the immunogenicity and sustainability of different doses Sabin strain inactivated poliovirus vaccine (sIPV) in different preparations of DTaP-sIPV . Methods  DTaP-sIPV with high or low dose sIPV was produced using 2 fomulations. Seventy rats were simply randomized into 7 groups (10 per group), which were F1H (DTaP-sIPV high dose, formulation 1), F2H (DTaP-sIPV high dose, formulation 2), sIPV-H (sIPV high dose), F1L (DTaP-sIPV low dose, formulation 1), F2L (DTaP-sIPV low dose, formulation 2), sIPV-L (sIPV low dose), and Sanofi Pasteur pentavalent vaccine PENTAXIM control group. Animals were immunized intramuscularly with 0.5 ml vaccine on hind limbs at 0, 3, and 6 week. Blood was drawn from eyes at 0, 3, 6, 9, 13, 17, 21, and 25 week. The titers of neutralizing antibodies against 3 types of poliovirus (PV) were determined by microcytopathic effect inhibition assay. Results  The neutralizing antibodies against PV1, PV2, and PV3 continuously increased after each immunization to reach peak at 9 week, then decreased significantly from 13 week but retained relatively high levels up to 25 week. Comparing the geometric mean titers (GMT) of neutralizing antibodies in 7 groups, 3 weeks after 3 injections, anti-PV1 in F2H group was significantly higher than in PENTAXIM group (F=0.988, P=0.027); anti-PV2 in F2H group was higher than in F1H group, in sIPV-H group was higher than in F1H and PENTAXIM groups (F=2.391, all P<0.05); anti-PV3 showed no significant difference among all groups. The neutralizing antibodies against all 3 PV in F2H group after 3 immunizations were the highest at every point, but only anti-PV2 at 6 week reached statistical significance over F1H group. Conclusion  DTaP-sIPV immunization can induce neutralizing antibodies against all 3 PV in rats. The immunogenicity and sustaining time are no less than PENTAXIM. The GMT in DTaP-sIPV is no less than sIPV at same dose. The 2 preparations have no statistically significant effect on the immunogenicity of sIPV in DTaP-sIPV, though formulation 2 maybe more preferred.