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目的评价口服脊髓灰质炎(脊灰)减毒活疫苗(人二倍体细胞)[Oral Poliomyelitis Attenuated Live Vaccine(Human Diploid Cell),OPV(HDC)],在≥2月龄儿童中的安全性和免疫原性。方法采用随机、盲态、对照的原则进行设计,1200名2～5月龄婴儿随机接种OPV(HDC)和对照疫苗,用抗脊灰病毒中和抗体试验检测免疫前、后抗体。结果接种3剂OPV(HDC)后全身反应轻微,全程免疫后1个月,Ⅰ、Ⅱ、Ⅲ型中和抗体免疫成功率分别为98.28%、95.32%、95.34%;免疫后易感人群的Ⅰ、Ⅱ、Ⅲ型中和抗体几何平均滴度,分别为1∶1243.72、1∶234.38、1∶273.10。结论 OPV(HDC)在≥2月龄儿童中具有良好的安全性和免疫原性。
Objective To evaluate the safety and safety of Oral Poliomyelitis Attenuated Live Vaccine (OPP (HDC)] in oral poliovirus (poliovirus) Immunogenicity. Methods A randomized, blinded and controlled trial was designed. One hundred and twenty two to five month-old infants were randomly assigned to OPV (HDC) and control vaccines. Anti-poliovirus neutralizing antibody test was used to detect the antibody levels before and after immunization. Results The systemic reaction was mild after three doses of OPV (HDC). The immunization success rates of type I, type II and type III neutralizing antibodies were 98.28%, 95.32% and 95.34% respectively one month after the whole immunization. The geometric mean titers of type II and type III neutralizing antibodies were 1:1243.72, 1: 234.38 and 1: 273.10, respectively. Conclusion OPV (HDC) has good safety and immunogenicity in children ≥ 2 months old.