国产吸附无细胞白百破联合疫苗的免疫持久性

Immune Persistence of Domestic Adsorhed Acellular Diphtheria Tetanus and Pertussis Combined Vaccine

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 domestic adsorhed acellular diphtheria tetanus and pertussis Ccombined vaccine （DTaP）. [ Methods] The 3-month-old healthy infants, without vaccination contraindication, unvaccinated DDT were selected and divided into 2 groups by randomized, double-blind and parallel-controlled similar vaccine design method; the 2 groups were inoculated respectively with A, B Dtap made by 2 Institutes of Biological Products. Full immunization 1 month later and 1 year later, mining vein blood respectively, diphtheria （ DT）, tetanus antibody （TT） were measured by indirect hemagglutination method. Antibody anti-pertussis toxin （DT） and anti-filamentous hemagglutinin antibody （ FHA） were measured by using ELISA method. [Results]DTaP full immunization I year later, the DT, TT, PT, FHA antibody GMTs were maintained at a high level, compared with antibody GMT after 1 month, the difference was not significant （ P 〉 0.05 ） ; the difference of immunogenicity between the 2 DTaP （immunization after 1 month, 1 year） was not significant （ P 〉0.05）. [ Conclusion] Domestic DTaP vaccine was safe, with strong immunogenicity and stable quality, will effectively control the occurrence of related diseases and epidemic when it is brought into national immunization program.