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目的评价国产b型流感嗜血杆菌(Haemophilus influenzae type b,Hib)结合疫苗PRP-TT的加强免疫效果。方法分别用安儿宝和呵儿贝两种Hib结合疫苗,对在广西柳州市常住儿童进行3、4、5月龄3针免疫,1年后,进行第4剂加强免疫。分别于3针免疫1年后和加强免疫1个月后采血,分离血清,采用ELISA和体外杀菌实验(Serum bactericidal assay,SBA)分别检测免疫前后血清IgG抗体浓度和加强免疫后SBA抗体滴度。结果安儿宝和呵儿贝疫苗3针免疫1年后,血清IgG抗体几何平均数浓度(Geometric mean concentrations,GMCs)分别为3.17μg/ml和3.00μg/ml,二者差异无统计学意义(P>0.05);其中,IgG抗体浓度在1.00μg/ml以上的血清所占的比例分别为79%(62/78)和76%(115/152),二者差异无统计学意义(P>0.05)。加强免疫后1个月,两种疫苗免疫血清中IgG抗体GMCs分别为71.33μg/ml和65.35μg/ml,二者差异无统计学意义(P>0.05);IgG抗体浓度均能100%达1.00μg/ml以上。两种疫苗加强免疫后的血清IgG抗体浓度与各自加强免疫前比较,差异均有统计学意义(P<0.05)。加强免疫后,两种疫苗免疫血清的SBA抗体滴度分别为5 263和4 637,二者差异无统计学意义(P>0.05)。两种疫苗免疫后血清IgG抗体浓度和SBA抗体滴度均具有相关性(r值分别为0.696和0.689,P<0.05)。结论 3针免疫1年后,两种疫苗免疫血清中IgG抗体仍保持较高的水平,第4剂加强免疫后,抗体水平迅速显著升高,100%达1.00μg/ml以上,且具有有效的体外杀菌功能。
Objective To evaluate the boosting effect of domestic Haemophilus influenzae type b (Hib) conjugate vaccine PRP-TT. Methods Two kinds of Hib conjugate vaccines were respectively used to treat 3, 4 and 5 months of age-old children in Liuzhou, Guangxi. One year later, the fourth dose was boosted. Serum samples were collected at 1 year after 3 doses of immunization and 1 month after immunization. Serum bactericidal assay (ELISA) and serological bactericidal assay (SBA) were used to detect serum IgG antibody concentration and immune SBA antibody titer respectively. Results After 1 year of immunization with 3 doses of Amgen and Aphrodisiac vaccines, the geometric mean concentrations (GMEs) of serum IgG were 3.17μg / ml and 3.00μg / ml, respectively, with no significant difference P> 0.05). Serum IgG concentrations above 1.00μg / ml accounted for 79% (62/78) and 76% (115/152), respectively, with no significant difference between the two groups (P> 0.05). The IgG antibody GMCs of the two vaccine immunized sera were 71.33μg / ml and 65.35μg / ml respectively at one month after booster immunization, the difference was not statistically significant (P> 0.05). The IgG antibody concentration could reach 100% μg / ml or more. The serum IgG antibody concentrations of the two vaccines after boosting were significantly different from those before boosting (P <0.05). After booster immunization, the SBA antibody titers of the two vaccine serums were respectively 5 263 and 4637, with no significant difference (P> 0.05). The serum IgG antibody titer and SBA antibody titer of the two vaccines were correlated (r = 0.696 and 0.689, respectively, P <0.05). Conclusions After 1 year of 3-needle immunization, the IgG antibodies of the two vaccines still maintain a high level. After the fourth immunization, the antibody levels rapidly and significantly increased to above 100μg / ml with a dose of 1.00μg / ml In vitro bactericidal function.