论文部分内容阅读
目的探讨国产吸附无细胞白百破联合疫苗(DTaP)的免疫持久性。方法选择无接种禁忌证、3月龄未接种DDT的健康婴儿,采用随机、双盲、同类疫苗平行对照设计的方法,将受试者分为2组,分别接种甲、乙2个生物制品研究所生产的DTaP,全程免疫后1个月、1年采静脉血,白喉抗体(DT)、破伤风抗体(TT)测定采用间接血凝法。抗百日咳毒素抗体(PT)和抗丝状血凝素抗体(FHA)采用酶联免疫吸附试验ELISA方法。结果DTaP全程免疫1年后,DT、TT、PT、FHA抗体GMT均维持在较高水平,与免后1个月抗体GMT差异无统计学意义(P>0.05);2家生物制品研究所DTaP免疫原性(免后1个月、1年)比较,差异无统计学意义(P>0.05)。结论国产DTaP疫苗安全,免疫原性强,质量稳定,纳入国家免疫规划后将有效控制相关疾病的发生和流行。
Objective To investigate the immune persistence of homemade cell-free baicalin combined vaccine (DTaP). Methods A healthy infant with no DDT at 3 months of age was selected. The randomized, double-blind and parallel vaccine design was adopted. The subjects were divided into two groups and inoculated with two biological products The production of DTaP, 1 month after the whole immunization, 1 year collected venous blood, diphtheria antibody (DT), tetanus antibody (TT) determination by indirect hemagglutination. Anti-Pertussis toxin antibodies (PTs) and anti-fibrinogen antibodies (FHA) were tested by enzyme-linked immunosorbent assay (ELISA). Results The GMT of DT, TT, PT, FHA antibodies maintained at a high level after 1 year of whole-dose DTaP immunization, and there was no significant difference between the two groups (P> 0.05). The two institutes of biological products DTaP Immunogenicity (1 month after surgery, 1 year), the difference was not statistically significant (P> 0.05). Conclusion The domestic DTaP vaccine is safe, strong in immunogenicity and stable in quality, and will effectively control the occurrence and prevalence of related diseases after being included in the national immunization program.