Objective: To evaluate the immunogenicity of different strains of inactivated poliomyelitis vaccines (IPV) by sequential program. Methods: This parallel-group controlled trial was conducted in immunization clinics in Shanghai from March 2016 to September 2017. Sabin strains inactivated poliomyelitis vaccines (sIPV), WPV strains inactivated poliomyelitis vaccines (wIPV) and live poliomyelitis Type Ⅰ Type Ⅲ vaccine (bOPV) as the investigational vaccine were used at 2, 3, 4 months old in 325 infants in Shanghai. Infants vaccinated by four sequential program were divided into 4 groups: sIPV+sIPV+bOPV, sIPV+wIPV+bOPV, wIPV+sIPV+bOPV and wIPV+wIPV+bOPV. A total of 230 investigators' blood samples were collected before primary immunization and 163 investigators' blood samples were collected after primary immunization. A total of 151 investigators (36, 44, 30 and 41 in each group) finished primary immunization and blood sampling before and after the primary immunization. The geometric mean titer (GMT) of poliovirus typesⅠ and Ⅲ neutralizing antibody was tested and calculated, and the positive results of antibody before and after primary immunization were analyzed. Results: Among the 151 investigators, the age were (2.27±0.61) months and birth weight were (3.27±0.43) kg, and 70 were male. The positive rates of typeⅠwas 98.68% (149 cases), and type Ⅲ was 97.35% (147 cases); the number of investigators tested in each group was 36, 44, 30 and 41, respectively; the positive rates of typeⅠwas 97.22% (35 cases), 100.00% (44 cases), 96.67% (29 cases) and 100.00% (41 cases) (P=0.345); the positive rates of type Ⅲ were 97.22% (35 cases), 95.45% (42 cases), 96.67% (29 cases) and 100.00% (41 cases) (P=0.614). Conclusion: Using sIPV and wIPV simultaneously or alternately for sequential immunization of poliomyelitis vaccines showed good immunogenicity for infants at appropriate age.
目的： 评价不同毒株脊髓灰质炎（脊灰）疫苗序贯免疫程序的免疫原性。 方法： 采用平行对照设计，于2016年3月至2017年9月，在上海市招募各区符合纳入排除标准的预防接种门诊受种者为研究对象，以Sabin株脊灰灭活疫苗（sIPV）、野毒株脊灰灭活疫苗（wIPV）和Ⅰ+Ⅲ型脊灰减毒活疫苗（bOPV）作为研究疫苗，按照4种序贯免疫程序进行基础免疫并分组，即接种sIPV+sIPV+bOPV、sIPV+wIPV+bOPV、wIPV+sIPV+bOPV和wIPV+wIPV+bOPV组，完成基础免疫前采血、基础免疫并采血者共151名，每组分别为36、44、30和41名；检测并计算脊灰Ⅰ、Ⅲ型中和抗体几何平均滴度（GMT）对数转换值，分析研究对象基础免疫后抗体阳性及阳转情况。 结果： 151名研究对象的月龄为（2.27±0.61）个月，出生体重为（3.27±0.43）kg，其中男性为70名。脊灰Ⅰ型中和抗体阳转率为98.68%（149例），Ⅲ型为97.35%（147例）；各组分别检测了36、44、30和41名，免疫后Ⅰ型阳转率分别为97.22%（35例）、100.00%（44例）、96.67%（29例）和100.00%（41例）（P=0.345），Ⅲ型分别为97.22%（35例）、95.45%（42例）、96.67%（29例）和100.00%（41例）（P=0.614）。 结论： 同时或交替使用sIPV和wIPV开展脊髓灰质炎疫苗序贯免疫程序对于适龄婴儿均具有良好的免疫原性。.
Keywords: Experimental studies; Immunocompetence; Poliomyelitis; Sequential program; Vaccines, inactivated.